Trial | Phase | Enrollment | Study Type | Start Date | Status |
Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg? [NCT05617664] | | 150 participants (Anticipated) | Interventional | 2022-11-23 | Recruiting |
An Open-label, Randomized, 2-way Crossover Study to Evaluate the Pharmacokinetics of Mirabegron and Its Metabolites in Healthy Young and Elderly Male and Female Subjects [NCT01285596] | Phase 1 | 75 participants (Actual) | Interventional | 2009-03-31 | Completed |
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence [NCT05806164] | Phase 4 | 432 participants (Anticipated) | Interventional | 2023-06-06 | Recruiting |
Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study [NCT03600766] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-08-01 | Active, not recruiting |
A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects [NCT01284309] | Phase 1 | 321 participants (Actual) | Interventional | 2010-11-30 | Completed |
A Phase 1, Randomized, Double-Blind, Placebo and Active Controlled, Parallel Crossover Study to Evaluate the Effect of Repeat Oral Doses of Mirabegron on Cardiac Repolarization in Healthy Male and Female Adult Subjects [NCT01199523] | Phase 1 | 352 participants (Actual) | Interventional | 2010-05-31 | Completed |
A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC) [NCT01297179] | Phase 1 | 30 participants (Actual) | Interventional | 2008-10-31 | Completed |
Far Eastern Memorial Hospital [NCT03695822] | Phase 4 | 0 participants (Actual) | Interventional | 2018-12-24 | Withdrawn(stopped due to I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case.) |
Comparative Study of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After Transurethral Resection of the Prostate - A Randomized Prospective Study [NCT03632772] | Phase 2 | 130 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB) [NCT02386072] | | 1,524 participants (Actual) | Observational | 2015-01-05 | Completed |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Comparison Clinical Study to Investigate the Efficacy and Safety of the β3 Adrenoceptor Agonist, Mirabegron With Overactive Bladder Symptoms in Men [NCT02361502] | Phase 4 | 462 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers [NCT01334905] | Phase 1 | 12 participants (Actual) | Interventional | 2011-03-31 | Completed |
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects [NCT02127034] | Phase 1 | 26 participants (Actual) | Interventional | 2014-03-31 | Completed |
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania [NCT03602508] | | 5,589 participants (Actual) | Observational | 2018-07-20 | Completed |
An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirab [NCT01297192] | Phase 1 | 41 participants (Actual) | Interventional | 2009-03-31 | Completed |
An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects. [NCT01284868] | Phase 1 | 12 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder [NCT01604928] | Phase 2 | 260 participants (Actual) | Interventional | 2004-04-30 | Completed |
Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study [NCT05946902] | Phase 4 | 150 participants (Anticipated) | Interventional | 2023-09-12 | Recruiting |
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial [NCT05490082] | Phase 3 | 100 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
Effects of Sympathicomimetic Agonists on the Disease Course and Mutant Allele Burden in Patients With JAK2-mutated Myeloproliferative Neoplasms. A Multicenter Phase II Trial. [NCT02311569] | Phase 2 | 39 participants (Actual) | Interventional | 2015-04-30 | Completed |
Effect of Mirabegron on Bladder Compliance ; a Prospective Paired Comparison of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance [NCT05745584] | | 15 participants (Anticipated) | Interventional | 2016-01-12 | Active, not recruiting |
Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence With Treatment in Overactive Bladder (OAB) Patients Prescribed Betmiga® - A Multicenter Non-interventional Post Authorisation Study (PAS) [NCT02320773] | | 863 participants (Actual) | Observational | 2014-11-25 | Completed |
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy [NCT03612401] | Early Phase 1 | 20 participants (Actual) | Interventional | 2018-12-05 | Completed |
Mirabegron For Erectile Dysfunction [NCT02916693] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2017-08-01 | Completed |
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder [NCT00688688] | Phase 3 | 2,792 participants (Actual) | Interventional | 2008-04-25 | Completed |
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) [NCT00410514] | Phase 2 | 200 participants (Actual) | Interventional | 2006-12-31 | Completed |
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Ur [NCT02757768] | Phase 4 | 715 participants (Actual) | Interventional | 2016-06-13 | Completed |
Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Predictive Factors for the First Line Use and the Dose Effectiveness Relationship [NCT03059134] | Phase 3 | 168 participants (Actual) | Interventional | 2015-04-28 | Completed |
Identifying Responsible Signaling Pathway for Adrenergic Beta-3 Receptor Regulation in Human Subcutaneous White Adipose Tissue [NCT05634174] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
Mirabegron and Physiological Function in Cold Environments - Aim 1 [NCT04766021] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2021-11-30 | Completed |
Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity [NCT05713799] | Phase 2 | 60 participants (Anticipated) | Interventional | 2024-01-03 | Not yet recruiting |
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial [NCT02095665] | Phase 4 | 22 participants (Actual) | Interventional | 2014-01-01 | Completed |
Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study [NCT03536494] | | 1,932 participants (Actual) | Interventional | 2017-01-01 | Completed |
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome [NCT05040984] | | 500 participants (Anticipated) | Observational | 2021-04-30 | Recruiting |
Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing [NCT03251300] | Phase 4 | 120 participants (Anticipated) | Interventional | 2017-08-01 | Recruiting |
Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study [NCT05880862] | Early Phase 1 | 48 participants (Anticipated) | Interventional | 2023-09-28 | Recruiting |
Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial [NCT05188742] | Phase 4 | 180 participants (Anticipated) | Interventional | 2021-11-10 | Recruiting |
A Multicentre, Open-Label, Single Dose, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overacti [NCT02526979] | Phase 1 | 9 participants (Actual) | Interventional | 2015-12-17 | Completed |
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics [NCT05051436] | Phase 4 | 96 participants (Anticipated) | Interventional | 2021-12-13 | Recruiting |
A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron [NCT00939757] | Phase 1 | 76 participants (Actual) | Interventional | 2009-05-31 | Completed |
Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia [NCT04503850] | | 100 participants (Anticipated) | Observational | 2020-10-01 | Not yet recruiting |
Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial [NCT03817931] | Phase 4 | 30 participants (Anticipated) | Interventional | 2019-08-05 | Recruiting |
A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178 [NCT00965926] | Phase 1 | 72 participants (Actual) | Interventional | 2009-07-31 | Completed |
Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease) [NCT02570035] | | 316 participants (Actual) | Observational | 2012-12-31 | Completed |
A Multi-centre Randomized, Placebo-controlled Trial of Mirabegron, a New beta3-adrenergic Receptor Agonist on Left Ventricular Mass and Diastolic Function in Patients With Structural Heart Disease [NCT02599480] | Phase 2 | 296 participants (Actual) | Interventional | 2016-04-30 | Active, not recruiting |
Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder [NCT02622555] | | 221 participants (Actual) | Observational | 2013-08-31 | Completed |
A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition [NCT02536976] | Phase 4 | 7 participants (Actual) | Interventional | 2015-12-31 | Completed |
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects [NCT02169713] | Phase 1 | 20 participants (Actual) | Interventional | 2014-05-31 | Completed |
THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS [NCT06124066] | Phase 4 | 42 participants (Actual) | Interventional | 2022-07-01 | Completed |
Efficacy and Safety of Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder [NCT03558919] | Phase 4 | 81 participants (Actual) | Interventional | 2017-01-01 | Completed |
A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China [NCT03572231] | | 805 participants (Actual) | Observational | 2018-07-19 | Completed |
An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers. [NCT04485585] | Phase 1 | 36 participants (Actual) | Interventional | 2020-07-20 | Completed |
Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Comparison of Therapeutic Efficacy and Safety Between 25mg and 50mg [NCT03044912] | Phase 3 | 574 participants (Anticipated) | Interventional | 2015-11-16 | Recruiting |
Mirabegron and Physiological Function in Cold Environments - Aim 1 [NCT05990387] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2023-07-19 | Recruiting |
A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis [NCT02787083] | Phase 3 | 9 participants (Actual) | Interventional | 2016-08-31 | Terminated(stopped due to Low enrollment) |
Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder [NCT03106623] | Phase 2 | 207 participants (Actual) | Interventional | 2017-04-07 | Completed |
An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults [NCT05992428] | Phase 1 | 36 participants (Anticipated) | Interventional | 2023-08-22 | Recruiting |
An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With [NCT02751931] | Phase 3 | 91 participants (Actual) | Interventional | 2016-06-17 | Completed |
Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR) [NCT02086188] | Phase 4 | 28 participants (Actual) | Interventional | 2014-05-31 | Completed |
Using Mirabegron to Increase Blood Pressure in Patients With Postural Orthostatic Tachycardia Syndrome [NCT06133075] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-11-22 | Not yet recruiting |
The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury [NCT02893553] | Phase 2 | 41 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00662909] | Phase 3 | 2,149 participants (Actual) | Interventional | 2008-03-28 | Completed |
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial [NCT02540707] | Phase 4 | 113 participants (Actual) | Interventional | 2015-09-08 | Completed |
Beta3 Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure [NCT02775539] | Phase 2 | 80 participants (Anticipated) | Interventional | 2016-06-30 | Not yet recruiting |
A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Assess the Pharmacokinetics of Mirabegron OCAS Formulations With Different Release Rates Versus IV Infusion in Healthy Volunteers [NCT00940121] | Phase 1 | 91 participants (Actual) | Interventional | 2009-04-30 | Completed |
Beta 3 Agonist Treatment in Heart Failure-2 [NCT03926754] | Phase 2/Phase 3 | 56 participants (Actual) | Interventional | 2017-01-23 | Completed |
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder [NCT00689104] | Phase 3 | 2,336 participants (Actual) | Interventional | 2008-04-28 | Completed |
A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects With Symptoms of Overactive Bladder [NCT00912964] | Phase 3 | 2,030 participants (Actual) | Interventional | 2009-04-28 | Completed |
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects [NCT00856570] | Phase 1 | 24 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain [NCT05658874] | Phase 3 | 80 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder [NCT00840645] | Phase 3 | 204 participants (Actual) | Interventional | 2008-12-31 | Completed |
A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects [NCT04562090] | Phase 4 | 249 participants (Actual) | Interventional | 2021-01-06 | Completed |
Sympathomimetics and Sympatholytics in Type 2 Diabetes: Teaching Old Drugs New Tricks [NCT04823442] | | 9 participants (Actual) | Interventional | 2021-01-21 | Completed |
The Activation of Brown and Beige Fat and Role in Insulin Sensitivity [NCT02919176] | Early Phase 1 | 39 participants (Actual) | Interventional | 2016-09-01 | Completed |
Title: A Randomized Clinical Trial Comparing Percutaneous Tibial Nerve Stimulation in Combination With Mirabegron to Percutaneous Tibial Nerve Stimulation Plus Placebo in Women With Refractory OAB Symptoms [NCT04907032] | Phase 4 | 54 participants (Actual) | Interventional | 2021-10-01 | Completed |
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder [NCT00966004] | Phase 3 | 1,139 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178 [NCT00750620] | Phase 1 | 33 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178) [NCT00776516] | Phase 1 | 24 participants (Actual) | Interventional | 2008-10-31 | Completed |
A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder [NCT04641975] | Phase 3 | 26 participants (Actual) | Interventional | 2021-03-15 | Terminated(stopped due to Termination due to operational futility) |
Long-Term Specified Drug Use-results Survey of Betanis Tablets [NCT01901120] | | 1,263 participants (Actual) | Observational | 2012-10-31 | Completed |
To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker [NCT04693897] | | 400 participants (Anticipated) | Observational [Patient Registry] | 2021-03-01 | Not yet recruiting |
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder [NCT01043666] | Phase 3 | 1,126 participants (Actual) | Interventional | 2009-12-31 | Completed |
Beta 3 Agonist Treatment in Heart Failure [NCT01876433] | Phase 2 | 70 participants (Actual) | Interventional | 2013-09-30 | Completed |
Drug Use-Results Survey of Betanis Tablets 25 and 50 mg [NCT01919047] | | 10,711 participants (Actual) | Observational | 2012-04-30 | Completed |
Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine - [NCT01964183] | Phase 4 | 24 participants (Actual) | Interventional | 2013-06-30 | Completed |
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity [NCT05968885] | Phase 4 | 300 participants (Anticipated) | Interventional | 2021-10-01 | Recruiting |
An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Thre [NCT02010944] | Phase 1 | 72 participants (Actual) | Interventional | 2012-09-30 | Completed |
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence [NCT05362292] | Phase 4 | 270 participants (Anticipated) | Interventional | 2022-10-04 | Recruiting |
A Multicentre, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS Tablets in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Ov [NCT02211846] | Phase 1 | 34 participants (Actual) | Interventional | 2014-09-21 | Completed |
Predictor for Re-treatment of Overactive Bladder Syndrome After Discontinuation of Mirabegron Treatment for Female Overactive Bladder Syndrome [NCT04550702] | | 120 participants (Actual) | Observational | 2015-01-01 | Completed |
An Exploratory Open Label, Three-way Crossover Study to Compare the Pharmacokinetic Profiles of Three Different YM178 Modified Release (OCAS) Formulations Under Fasted and Fed Conditions With YM178 Immediate Release (IR) Formulation Under Fasted Condition [NCT01646294] | Phase 1 | 34 participants (Actual) | Interventional | 2005-01-31 | Completed |
EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA. [NCT02279615] | Phase 4 | 200 participants (Anticipated) | Interventional | 2021-12-31 | Not yet recruiting |
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron [NCT01340027] | Phase 2 | 1,307 participants (Actual) | Interventional | 2011-03-29 | Completed |
Effect of Mirabegron on Promoting Brown Adipose Tissue Activation [NCT05779514] | | 20 participants (Anticipated) | Interventional | 2022-08-18 | Recruiting |
Mirabegron And Ureteral Stent-related Pain (MAP) Trial [NCT04286152] | Phase 3 | 142 participants (Anticipated) | Interventional | 2020-02-03 | Recruiting |
Pharmacological or Cold-induced Activation of Brown Adipose Tissue Metabolism [NCT02811289] | | 22 participants (Actual) | Interventional | 2016-08-05 | Completed |
Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial [NCT06184334] | | 300 participants (Actual) | Interventional | 2022-09-14 | Completed |
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder [NCT00337090] | Phase 2 | 1,108 participants (Actual) | Interventional | | Completed |
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron 50mg in Sexually Active Men With Bothersome Overactive Bladder Symptoms - A Multicenter, Randomized Study [NCT04420533] | | 150 participants (Actual) | Interventional | 2020-06-05 | Completed |
Mirabegron Combined With Behavioral Intervention for Overactive Bladder:a Prospective Multicenter Randomized Controlled Clinical Study [NCT05452434] | Phase 4 | 600 participants (Anticipated) | Interventional | 2022-07-15 | Not yet recruiting |
Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial [NCT04325880] | Phase 3 | 240 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin [NCT01489696] | Phase 1 | 48 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder [NCT00527033] | Phase 2 | 842 participants (Actual) | Interventional | 2007-09-30 | Completed |
An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers [NCT01720212] | Phase 1 | 24 participants (Actual) | Interventional | 2012-05-31 | Completed |
An Open Label Randomized, Single Dose, Three-way, Partial Replicate Bioequivalence Study to Determine the Bioequivalence of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg F [NCT05767632] | Phase 1 | 30 participants (Actual) | Interventional | 2022-05-30 | Completed |
A Phase 1, Open-Label, Two-Period, One-Sequence Crossover Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Male and Female Adult Volunteers [NCT01476800] | Phase 1 | 24 participants (Actual) | Interventional | 2006-07-31 | Completed |
An Open Label, One-sequence, Parallel Study to Compare the Single Dose Pharmacokinetics of YM178 in Healthy Poor or Extensive Metabolisers for CYP2D6 and to Assess the Effect of Multiple Doses of YM178 on the Metabolism of the Model Substrate Metoprolol [NCT01478490] | Phase 1 | 28 participants (Actual) | Interventional | 2002-09-30 | Completed |
Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-M in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female S [NCT01478503] | Phase 1 | 96 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation [NCT01478529] | Phase 1 | 12 participants (Actual) | Interventional | 2006-02-28 | Completed |
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects [NCT01478568] | Phase 1 | 28 participants (Actual) | Interventional | 2008-10-31 | Completed |
The Effect of Mirabegron on Brown Adipose Tissue in Healthy Young White Caucasian and South Asian Men [NCT03012113] | Phase 4 | 20 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study. [NCT04023253] | Phase 3 | 120 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting |
A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB) [NCT06181591] | Phase 2 | 44 participants (Anticipated) | Interventional | 2024-01-15 | Not yet recruiting |
Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial [NCT06181019] | Phase 1 | 75 participants (Actual) | Interventional | 2021-12-01 | Active, not recruiting |
Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial [NCT03412513] | Phase 4 | 144 participants (Anticipated) | Interventional | 2017-07-17 | Recruiting |
The Therapeutic Effect of Beta-3 Agonist and Anti-muscarinic Agent on Overactive Bladder Among Sjogren's Syndrome Patient [NCT04909255] | Phase 4 | 50 participants (Anticipated) | Interventional | 2021-03-23 | Recruiting |
[NCT02436889] | Phase 4 | 23 participants (Actual) | Interventional | 2016-02-29 | Completed |
A Double Blind Placebo Control Trial of Mirabegron for Medical Expulsive Therapy and to Manage Stent Pain for Ureteral Stones(Protocol # 01-16-20-02) [NCT02744430] | Phase 2 | 33 participants (Actual) | Interventional | 2017-07-22 | Completed |
Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue [NCT01783470] | Phase 2 | 15 participants (Actual) | Interventional | 2013-02-28 | Completed |
Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation [NCT02981459] | Phase 4 | 0 participants (Actual) | Interventional | 2017-12-08 | Withdrawn(stopped due to Withdrawn by Sponsor) |
A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children [NCT05621616] | Phase 3 | 10 participants (Anticipated) | Interventional | 2023-06-26 | Recruiting |
An Open-label Study to Evaluate the Pharmacokinetics of YM178 After Single Oral Administration of 14C-labeled YM178 in Healthy Male Volunteers [NCT01651312] | Phase 1 | 4 participants (Actual) | Interventional | 2003-01-31 | Completed |
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Digoxin in Healthy Subjects [NCT01663961] | Phase 1 | 25 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects [NCT01747564] | Phase 1 | 24 participants (Actual) | Interventional | 2012-08-31 | Completed |
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists [NCT03049462] | Phase 1 | 100 participants (Anticipated) | Interventional | 2017-03-13 | Recruiting |
The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate [NCT01950520] | Phase 2 | 134 participants (Anticipated) | Interventional | 2014-02-07 | Recruiting |
An Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study to Determine the Bioequivalence of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Indust [NCT04476966] | Phase 1 | 29 participants (Actual) | Interventional | 2020-01-20 | Completed |
A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects [NCT04501640] | Phase 4 | 24 participants (Actual) | Interventional | 2020-09-21 | Completed |
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO) [NCT02092181] | Phase 4 | 30 participants (Actual) | Interventional | 2014-03-31 | Completed |
An Open Label Single Dose Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of YM178 Compared With Healthy Subjects [NCT01579461] | Phase 1 | 32 participants (Actual) | Interventional | 2008-11-30 | Completed |
Mechanisms for Activation of Beige Adipose Tissue in Humans [NCT04666636] | Phase 2 | 65 participants (Anticipated) | Interventional | 2020-12-07 | Recruiting |
Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study [NCT03411252] | Early Phase 1 | 5 participants (Actual) | Interventional | 2018-02-15 | Terminated(stopped due to inability to enroll) |
Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome [NCT02495389] | Phase 4 | 84 participants (Actual) | Interventional | 2015-01-28 | Completed |
Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder [NCT02476175] | Phase 3 | 35 participants (Actual) | Interventional | 2013-04-30 | Completed |
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subject [NCT02045862] | Phase 3 | 1,829 participants (Actual) | Interventional | 2014-03-17 | Completed |
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage [NCT05369351] | Phase 2 | 66 participants (Anticipated) | Interventional | 2023-01-10 | Not yet recruiting |
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women [NCT05604222] | Phase 4 | 120 participants (Anticipated) | Interventional | 2023-03-01 | Recruiting |
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy [NCT01638000] | Phase 3 | 1,887 participants (Actual) | Interventional | 2012-06-12 | Completed |
Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy [NCT03087578] | | 0 participants (Actual) | Interventional | 2017-07-01 | Withdrawn(stopped due to Study never started) |
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) [NCT02216214] | Phase 4 | 888 participants (Actual) | Interventional | 2014-10-07 | Completed |
A Multicenter Prospective Study for Patient Perception of Treatment Satisfaction After Switching to Mirabegron in Patients With Overactive Bladder Who Were Unsatisfied With Efficacy of Antimuscarinic Therapy or Adverse Event. [NCT02468375] | Phase 4 | 434 participants (Actual) | Interventional | 2015-06-30 | Completed |
A Double Blind, Randomized Placebo Controlled Trial Evaluating the Urodynamic and Clinical Efficacy of Mirabegron Among Neurogenic Bladder Patients [NCT02044510] | Phase 2/Phase 3 | 32 participants (Actual) | Interventional | 2014-07-31 | Terminated(stopped due to Slow recruitment and small observed effect size) |
Efficacy of Pharmacological Stimulation of Brown and White Fat in Lean and Obese Young Adults [NCT02354807] | Phase 2 | 20 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial [NCT03187795] | Phase 2 | 62 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS) [NCT02410135] | | 34 participants (Actual) | Observational | 2015-04-30 | Completed |
Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma [NCT01898624] | | 300 participants (Actual) | Observational | 2012-12-04 | Completed |
A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms [NCT01908829] | Phase 3 | 2,174 participants (Actual) | Interventional | 2013-07-10 | Completed |
Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron [NCT02294396] | Phase 4 | 649 participants (Actual) | Interventional | 2014-10-28 | Completed |
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monot [NCT01972841] | Phase 3 | 3,527 participants (Actual) | Interventional | 2013-11-05 | Completed |
The Effects of Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Urinary Frequency, Urgency and Urge Incontinence [NCT06123364] | | 56 participants (Actual) | Interventional | 2019-10-14 | Completed |
A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB) [NCT02138747] | Phase 4 | 376 participants (Actual) | Interventional | 2014-07-24 | Completed |
Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement [NCT02462837] | Phase 2 | 11 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to insufficient rate of accrual) |
Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan [NCT01745094] | Phase 4 | 223 participants (Actual) | Interventional | 2012-10-01 | Completed |
A Phase 4, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Mirabegron in Japanese and Korean Male Patients With Overactive Bladder Under Treatment With the α-Blocker Tamsulosin for Benign Prostatic Hyp [NCT02656173] | Phase 4 | 568 participants (Actual) | Interventional | 2016-01-25 | Completed |
Does Mirabegron Increase the Body Heat Generated by the Nervous System [NCT06011265] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2023-04-27 | Recruiting |
Prospective Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder [NCT02468830] | Phase 3 | 58 participants (Actual) | Interventional | 2013-04-30 | Completed |
Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial [NCT05221021] | Phase 4 | 152 participants (Anticipated) | Interventional | 2022-10-01 | Recruiting |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score |
NCT00410514 (18) [back to overview] | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) |
NCT00410514 (18) [back to overview] | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) |
NCT00410514 (18) [back to overview] | Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE) |
NCT00410514 (18) [back to overview] | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR) |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC) |
NCT00410514 (18) [back to overview] | Change From Baseline to End of Treatment in Bladder Contractile Index (BCI) |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00410514 (18) [back to overview] | Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00662909 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours |
NCT00662909 (31) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00662909 (31) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit |
NCT00662909 (31) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00662909 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00662909 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00688688 (28) [back to overview] | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00688688 (28) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT00688688 (28) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit |
NCT00688688 (28) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) |
NCT00688688 (28) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit |
NCT00688688 (28) [back to overview] | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram |
NCT00688688 (28) [back to overview] | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00689104 (31) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit |
NCT00689104 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00689104 (31) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT00912964 (39) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT00912964 (39) [back to overview] | Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours |
NCT00912964 (39) [back to overview] | Percentage of Responders for Mean Level of Urgency |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency |
NCT00912964 (39) [back to overview] | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00912964 (39) [back to overview] | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit |
NCT00912964 (39) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
NCT00912964 (39) [back to overview] | Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale |
NCT00912964 (39) [back to overview] | Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency |
NCT00912964 (39) [back to overview] | Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT00912964 (39) [back to overview] | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT00912964 (39) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT00912964 (39) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score |
NCT00912964 (39) [back to overview] | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Health-related Quality of Life Total Score Response |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) |
NCT01340027 (30) [back to overview] | Percentage of Participants With Deterioration in PPBC |
NCT01340027 (30) [back to overview] | Percentage of Participants With Improvement in PPBC |
NCT01340027 (30) [back to overview] | Percentage of Participants With Major Improvement in PPBC |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score |
NCT01340027 (30) [back to overview] | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Level of Urgency |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) |
NCT01340027 (30) [back to overview] | Percentage of Participants With 50% Reduction in Incontinence Episodes |
NCT01340027 (30) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Post-baseline |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Symptom Bother Response |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) |
NCT01340027 (30) [back to overview] | Percentage of Participants With a Micturition Response |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01340027 (30) [back to overview] | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01638000 (47) [back to overview] | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit |
NCT01638000 (47) [back to overview] | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period |
NCT01638000 (47) [back to overview] | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment |
NCT01638000 (47) [back to overview] | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours |
NCT01638000 (47) [back to overview] | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit |
NCT01638000 (47) [back to overview] | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) |
NCT01638000 (47) [back to overview] | Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale |
NCT01638000 (47) [back to overview] | Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in Postvoid Residual (PVR) Volume |
NCT01745094 (15) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours |
NCT01745094 (15) [back to overview] | Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in OAB-q SF Total HRQL Score |
NCT01745094 (15) [back to overview] | Change From Baseline in OABSS Total Score |
NCT01745094 (15) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score |
NCT01745094 (15) [back to overview] | Number of Participants Who Achieved Normalization for OABSS Total Score |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Micturitions Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Nocturia Episodes Per Night |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Number of Urgency Episodes Per 24 Hours |
NCT01745094 (15) [back to overview] | Change From Baseline in the Volume Voided Per Micturition |
NCT01783470 (1) [back to overview] | BAT Activity as Measured by 18F-FDG PET/CT |
NCT01908829 (36) [back to overview] | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score |
NCT01908829 (36) [back to overview] | Change From Baseline in Patient Perception Bladder Control (PPBC) Score |
NCT01908829 (36) [back to overview] | Change From Baseline in Post Void Residual (PVR) Volume |
NCT01908829 (36) [back to overview] | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score |
NCT01908829 (36) [back to overview] | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Number of Incontinence Episodes Reported During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Nocturia Episodes Reported Over 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Pads Used During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) |
NCT01908829 (36) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities |
NCT01908829 (36) [back to overview] | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility |
NCT01908829 (36) [back to overview] | Number of UI Episodes Reported During the 3-Day Diary |
NCT01908829 (36) [back to overview] | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score |
NCT01908829 (36) [back to overview] | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC |
NCT01908829 (36) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Postbaseline |
NCT01908829 (36) [back to overview] | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Micturitions Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Nocturia Episodes |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Pads Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours |
NCT01908829 (36) [back to overview] | Change From Baseline in Mean Volume Voided (MVV) Per Micturition |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Concern |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Coping |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Sleep |
NCT01908829 (36) [back to overview] | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8 and 12 in TS-VAS |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern |
NCT01972841 (70) [back to overview] | Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC) |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Pads Used at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT01972841 (70) [back to overview] | Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | PGIC Scale: Impression in General Health at Week 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT |
NCT01972841 (70) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Mean Volume Voided Per Micturition |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities |
NCT01972841 (70) [back to overview] | Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility |
NCT01972841 (70) [back to overview] | Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed |
NCT01972841 (70) [back to overview] | Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping |
NCT02044510 (1) [back to overview] | Bladder Capacity |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score |
NCT02045862 (53) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT |
NCT02045862 (53) [back to overview] | Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT |
NCT02045862 (53) [back to overview] | Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT |
NCT02045862 (53) [back to overview] | Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02045862 (53) [back to overview] | Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score |
NCT02045862 (53) [back to overview] | Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Mean Volume Voided Per Micturition |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to EoT in Corrected Micturition Frequency |
NCT02045862 (53) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT02045862 (53) [back to overview] | Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours |
NCT02086188 (7) [back to overview] | Mean # of Incontinence Episodes/Day |
NCT02086188 (7) [back to overview] | Subject Global Impression (Single Question) |
NCT02086188 (7) [back to overview] | Qualiveen Questionnaire |
NCT02086188 (7) [back to overview] | Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit |
NCT02086188 (7) [back to overview] | Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit |
NCT02086188 (7) [back to overview] | Mean Volume Voided/Micturition |
NCT02086188 (7) [back to overview] | Mean # of Micturitions/Day Based on Voiding Diaries |
NCT02092181 (7) [back to overview] | Change in Mean Daily OAB-SCS Visit 3 vs Baseline |
NCT02092181 (7) [back to overview] | Change in the Mean Daily Overactive Bladder-Symptom Composite Score. |
NCT02092181 (7) [back to overview] | Change in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02092181 (7) [back to overview] | Non- Motor Symptoms Scale (NMSS) |
NCT02092181 (7) [back to overview] | Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q) |
NCT02092181 (7) [back to overview] | Patient Perception of Bladder Condition |
NCT02092181 (7) [back to overview] | Subjects Global Impression of Change |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB |
NCT02138747 (13) [back to overview] | Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02138747 (13) [back to overview] | Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours |
NCT02138747 (13) [back to overview] | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication |
NCT02138747 (13) [back to overview] | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control |
NCT02138747 (13) [back to overview] | Number of Participants With Adverse Events |
NCT02138747 (13) [back to overview] | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. |
NCT02216214 (25) [back to overview] | Change From Baseline in Post-void Residual Volume (PVR) |
NCT02216214 (25) [back to overview] | Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Barthel Index of Daily Living Score |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in OAB-q HRQL Subscale Scores |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Mean Volume Voided Per Micturition |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC) |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in PPIUS |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS) |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA) |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score |
NCT02216214 (25) [back to overview] | Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT02216214 (25) [back to overview] | Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC |
NCT02216214 (25) [back to overview] | Percentage of Participants Who Achieved Micturition Frequency Normalization |
NCT02216214 (25) [back to overview] | Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales |
NCT02216214 (25) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT02216214 (25) [back to overview] | Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02216214 (25) [back to overview] | Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC |
NCT02216214 (25) [back to overview] | Percentage of Participants With Zero Incontinence Episodes Per 24 Hours |
NCT02216214 (25) [back to overview] | Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit |
NCT02216214 (25) [back to overview] | Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Nocturia Episodes Per Night |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Volume Voided Per Micturition |
NCT02294396 (16) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02294396 (16) [back to overview] | Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours |
NCT02294396 (16) [back to overview] | Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization for OABSS Total Score |
NCT02294396 (16) [back to overview] | Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours |
NCT02294396 (16) [back to overview] | Change From Baseline in OAB-q SF Total HRQL Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score |
NCT02294396 (16) [back to overview] | Change From Baseline in Postvoid Residual (PVR) Volume |
NCT02436889 (5) [back to overview] | Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks. |
NCT02436889 (5) [back to overview] | Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks |
NCT02436889 (5) [back to overview] | Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks |
NCT02462837 (6) [back to overview] | Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group. |
NCT02462837 (6) [back to overview] | Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group. |
NCT02462837 (6) [back to overview] | Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up. |
NCT02462837 (6) [back to overview] | Reduction in Pain Medicine Intake at the 2 Week Follow-up |
NCT02462837 (6) [back to overview] | Reduction in Pain Medicine Intake at the 2 Week Follow-up |
NCT02462837 (6) [back to overview] | Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up. |
NCT02468830 (5) [back to overview] | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron |
NCT02468830 (5) [back to overview] | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron |
NCT02468830 (5) [back to overview] | Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale |
NCT02468830 (5) [back to overview] | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron |
NCT02468830 (5) [back to overview] | Number of Participants With Cardio Vascular Safety |
NCT02476175 (5) [back to overview] | Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy |
NCT02476175 (5) [back to overview] | Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron |
NCT02476175 (5) [back to overview] | Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries |
NCT02476175 (5) [back to overview] | Number of Participants Without Variation in Heart Rate |
NCT02476175 (5) [back to overview] | Number of Participants With Cardio Vascular Safety |
NCT02495389 (4) [back to overview] | Change in Urinary Distress Inventory (UDI) |
NCT02495389 (4) [back to overview] | Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score |
NCT02495389 (4) [back to overview] | Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) |
NCT02495389 (4) [back to overview] | Change in Colo-Rectal-Anal Distress Inventory (CRADI) |
NCT02536976 (3) [back to overview] | Change in Montreal Cognitive Assessment Total Score |
NCT02536976 (3) [back to overview] | Change in Unified Parkinson's Disease Rating Scale |
NCT02536976 (3) [back to overview] | Change in Overactive Bladder Questionnaire Subscale Scores |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS) |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q) |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Postvoid Residual (PVR) Volume |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Mean Volume Voided Per Micturition |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Mean Number of Nocturia Episodes |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS) |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax) |
NCT02656173 (16) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in IPSS Subscale Scores |
NCT02656173 (16) [back to overview] | Change From Baseline to EoT in OABSS Subscale Scores |
NCT02656173 (16) [back to overview] | Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours |
NCT02656173 (16) [back to overview] | Number of Participants With Adverse Events |
NCT02744430 (2) [back to overview] | Spontaneous Stone Passage Using Fisher's Exact Test |
NCT02744430 (2) [back to overview] | Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Oral Suspension at Week 24 |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Oral Suspension at Week 52 |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Tablets at Week 24 |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Tablets at Week 4 |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Tablets at Week 52 |
NCT02751931 (31) [back to overview] | Apparent Volume of Distribution After Non-intravenous Administration (Vz/F) of Mirabegron |
NCT02751931 (31) [back to overview] | Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 |
NCT02751931 (31) [back to overview] | Change From Baseline in Maximum Cystometric Capacity at Week 4 |
NCT02751931 (31) [back to overview] | Maximum Plasma Concentration (Cmax) of Mirabegron |
NCT02751931 (31) [back to overview] | Plasma Concentration of Mirabegron at the End of a Dosing Interval at Steady State (Ctrough) |
NCT02751931 (31) [back to overview] | Time to Reach Maximum Plasma Concentration of Mirabegron Following Drug Administration (Tmax) |
NCT02751931 (31) [back to overview] | Change From Baseline in Average Catheterized Volume Per Catheterization |
NCT02751931 (31) [back to overview] | Change From Baseline in Average Morning Catheterized Volume |
NCT02751931 (31) [back to overview] | Change From Baseline in Bladder Compliance (ΔV/ΔP) |
NCT02751931 (31) [back to overview] | Change From Baseline in Detrusor Pressure at End of Filling |
NCT02751931 (31) [back to overview] | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20) |
NCT02751931 (31) [back to overview] | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test |
NCT02751931 (31) [back to overview] | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis |
NCT02751931 (31) [back to overview] | Change From Baseline in Maximum Catheterized Daytime Volume (MCDV) |
NCT02751931 (31) [back to overview] | Change From Baseline in Maximum Catheterized Volume |
NCT02751931 (31) [back to overview] | Change From Baseline in Mean Number of Leakage Episodes Per Day |
NCT02751931 (31) [back to overview] | Change From Baseline in Mean Number of Leakage Episodes Per Day: Updated Analysis |
NCT02751931 (31) [back to overview] | Change From Baseline in Number of Dry Days Per 7 Days (Day and Night Time) |
NCT02751931 (31) [back to overview] | Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling |
NCT02751931 (31) [back to overview] | Change From Baseline in Patient Global Impression of Severity Scale (PGI-S) |
NCT02751931 (31) [back to overview] | Change From Baseline in Pediatric Incontinence Questionnaire (PIN-Q) Score |
NCT02751931 (31) [back to overview] | Apparent Total Clearance of Mirabegron From Plasma After Oral Administration (CL/F) |
NCT02751931 (31) [back to overview] | Number of Participants With Study Drug Acceptability for Oral Suspension at Week 4 |
NCT02751931 (31) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT02751931 (31) [back to overview] | Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) for Mirabegron |
NCT02751931 (31) [back to overview] | Number of Participants With Clinician Global Impression of Change (CGI-C) |
NCT02757768 (21) [back to overview] | Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS) |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS) |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC) |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition |
NCT02757768 (21) [back to overview] | Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day |
NCT02787083 (2) [back to overview] | Number of Participants With Interstitial Cystitis Symptom Improvement |
NCT02787083 (2) [back to overview] | Number of Participants With Improvement in Incontinence Episodes |
NCT02916693 (10) [back to overview] | Health Related Quality of Life as Assessed by the OAB Questionnaire |
NCT02916693 (10) [back to overview] | Health Related Quality of Life as Assessed by the OAB Questionnaire |
NCT02916693 (10) [back to overview] | Health Related Quality of Life as Assessed by the OAB Questionnaire |
NCT02916693 (10) [back to overview] | Health Related Quality of Life as Assessed by the OAB Questionnaire |
NCT02916693 (10) [back to overview] | Erectile Function Assessed by IIEF Questionnaire |
NCT02916693 (10) [back to overview] | Health Related Quality of Life as Assessed by the OAB Questionnaire |
NCT02916693 (10) [back to overview] | Erectile Function Assessed by IIEF Questionnaire |
NCT02916693 (10) [back to overview] | Erectile Function Assessed by IIEF Questionnaire |
NCT02916693 (10) [back to overview] | Erectile Function Assessed by IIEF Questionnaire |
NCT02916693 (10) [back to overview] | Erectile Function Assessed by IIEF Questionnaire |
NCT04501640 (4) [back to overview] | Maximum Concentration (Cmax) For Mirabegron |
NCT04501640 (4) [back to overview] | Number of Participants With Adverse Events (AE) |
NCT04501640 (4) [back to overview] | Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron |
NCT04501640 (4) [back to overview] | Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron |
NCT04562090 (9) [back to overview] | Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group |
NCT04562090 (9) [back to overview] | Change From Baseline to Week 12 in Post Void Residual (PVR) Volume |
NCT04562090 (9) [back to overview] | Number of Participants With Treatment Emergent Adverse Events |
NCT04562090 (9) [back to overview] | Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours |
NCT04562090 (9) [back to overview] | Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours |
NCT04562090 (9) [back to overview] | Change From Baseline in Mean Number of Micturition Per 24 Hours |
NCT04562090 (9) [back to overview] | Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours |
NCT04562090 (9) [back to overview] | Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours |
NCT04562090 (9) [back to overview] | Change From Baseline in OAB Symptom Score (OABSS) |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline in Post Void Residual (PVR) Volume |
NCT04641975 (14) [back to overview] | Change From Baseline in Post Void Residual (PVR) Volume |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years |
NCT04641975 (14) [back to overview] | Number of Participants With Study Drug Acceptability and Palatability for Oral Suspension |
NCT04641975 (14) [back to overview] | Number of Participants With Study Drug Acceptability and Palatability for Tablets |
NCT04641975 (14) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
NCT04641975 (14) [back to overview] | PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough) |
NCT04641975 (14) [back to overview] | PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough) |
NCT04907032 (4) [back to overview] | Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) |
NCT04907032 (4) [back to overview] | Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks |
NCT04907032 (4) [back to overview] | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) |
NCT04907032 (4) [back to overview] | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) |
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 63; 57] | Change from Baseline at Week 4 [N=63; 62; 58] | Change from Baseline at Week 8 [N=62; 63; 56] | Change from Baseline at Week 12 [N=58; 61; 52] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -1.6 | -4.4 | -5.3 | -4.8 | -4.8 |
,Mirabegron 50 mg | -2.4 | -5.2 | -6.3 | -6.3 | -6.2 |
,Placebo | -1.7 | -4.0 | -5.0 | -5.2 | -5.0 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 63; 57] | Change from Baseline at Week 4 [N=63; 62; 58] | Change from Baseline at Week 8 [N=62; 63; 57] | Change from Baseline at Week 12 [N=59; 61; 52] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -1.0 | -2.3 | -2.6 | -2.5 | -2.5 |
,Mirabegron 50 mg | -1.4 | -2.6 | -3.2 | -3.4 | -3.3 |
,Placebo | -0.7 | -1.7 | -2.1 | -2.2 | -2.2 |
[back to top]
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12
Intervention | mL/sec (Least Squares Mean) |
---|
Placebo | -0.33 |
Mirabegron 50 mg | 0.07 |
Mirabegron 100 mg | 0.30 |
[back to top]
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12
Intervention | cmH2O (Least Squares Mean) |
---|
Placebo | 2.92 |
Mirabegron 50 mg | -3.03 |
Mirabegron 100 mg | 1.53 |
[back to top]
Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12
Intervention | Percent voiding efficiency (Least Squares Mean) |
---|
Placebo | -3.01 |
Mirabegron 50 mg | -5.49 |
Mirabegron 100 mg | 2.06 |
[back to top]
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. (NCT00410514)
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
Intervention | participants (Number) |
---|
| Adverse events | Mild intensity adverse events | Moderate intensity adverse events | Severe intensity adverse events | Drug-related adverse events | Serious adverse events | AEs leading to study drug discontinuation | Deaths |
---|
Mirabegron 100 mg | 34 | 20 | 14 | 0 | 11 | 0 | 2 | 0 |
,Mirabegron 50 mg | 28 | 16 | 10 | 2 | 5 | 0 | 1 | 0 |
,Placebo | 28 | 17 | 7 | 4 | 8 | 0 | 2 | 0 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 4 [N=60; 60; 58] | Change from Baseline at Week 8 [N=61; 61; 56] | Change from Baseline at Week 12 [N=58; 60; 53] | Change from Baseline at EOT [N=62; 61; 58] |
---|
Mirabegron 100 mg | -3.5 | -4.9 | -5.4 | -5.5 |
,Mirabegron 50 mg | -4.0 | -5.1 | -4.9 | -4.8 |
,Placebo | -2.8 | -3.9 | -4.2 | -3.9 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score
"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 4 [N=58; 53; 56] | Change from Baseline at Week 8 [N=57; 57; 53] | Change from Baseline at Week 12 [N=54; 53; 51] | Change from Baseline at EOT [N=60; 57; 58] |
---|
Mirabegron 100 mg | -10.0 | -19.3 | -17.4 | -18.6 |
,Mirabegron 50 mg | -13.6 | -21.9 | -19.3 | -20.1 |
,Placebo | -7.5 | -11.6 | -15.1 | -14.0 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 4 [N=41; 37; 33] | Change from Baseline at Week 8 [N=39; 36; 31] | Change from Baseline at Week 12 [N=40; 30;26] | Change from Baseline at EOT [N=47; 40; 36] |
---|
Mirabegron 100 mg | -3.1 | -5.7 | -5.7 | -5.0 |
,Mirabegron 50 mg | -4.1 | -6.4 | -6.9 | -6.9 |
,Placebo | -3.2 | -4.8 | -4.7 | -4.8 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours
"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | Urgency episodes (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 64; 57] | Change from Baseline at Week 4 [N=63; 64; 58] | Change from Baseline at Week 8 [N=62; 63; 57] | Change from Baseline at Week 12 [N=62; 63; 54] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -0.60 | -0.95 | -0.98 | -0.90 | -0.93 |
,Mirabegron 50 mg | -0.81 | -1.13 | -1.43 | -1.65 | -1.60 |
,Placebo | 0.09 | -0.11 | -0.35 | -0.33 | -0.33 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score
"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 4 [N=61; 62; 58] | Change from Baseline at Week 8 [N=60; 63; 57] | Change from Baseline at Week 12 [N=59; 61; 53] | Change from Baseline at EOT [N=62; 63; 58] |
---|
Mirabegron 100 mg | -1.0 | -1.7 | -1.9 | -1.9 |
,Mirabegron 50 mg | -1.2 | -1.7 | -2.1 | -2.0 |
,Placebo | -0.4 | -0.9 | -1.1 | -1.1 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 66; 63] | Change from Baseline at Week 4 [N=63; 67; 63] | Change from Baseline at Week 8 [N=62; 67; 61] | Change from Baseline at Week 12 [N=59; 63; 57] | Change from Baseline at EOT [N=64; 70; 65] |
---|
Mirabegron 100 mg | 0.51 | 8.63 | -3.71 | 33.22 | 30.77 |
,Mirabegron 50 mg | -2.93 | -1.03 | 5.11 | 21.13 | 17.89 |
,Placebo | -8.10 | 1.08 | -9.92 | 4.65 | 0.55 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 63; 57] | Change from Baseline at Week 4 [N=63; 62; 58] | Change from Baseline at Week 8 [N=62; 63; 57] | Change from Baseline at Week 12 [N=60; 61; 53] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -0.6 | -0.6 | -0.9 | -0.9 | -0.8 |
,Mirabegron 50 mg | -0.3 | -0.5 | -0.7 | -0.9 | -0.9 |
,Placebo | -0.2 | -0.3 | -0.5 | -0.6 | -0.6 |
[back to top]
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
Placebo | 1.25 |
Mirabegron 50 mg | -2.60 |
Mirabegron 100 mg | 2.51 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 64; 57] | Change from Baseline at Week 4 [N=63; 64; 58] | Change from Baseline at Week 8 [N=62; 63; 57] | Change from Baseline at Week 12 [N=62; 63; 54] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | 10.38 | 18.31 | 22.83 | 16.20 | 15.80 |
,Mirabegron 50 mg | 6.71 | 12.55 | 14.52 | 16.62 | 15.82 |
,Placebo | 2.75 | 10.25 | 4.53 | 4.49 | 5.40 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 64; 57] | Change from Baseline at Week 4 [N=63; 64; 58] | Change from Baseline at Week 8 [N=62; 63; 57] | Change from Baseline at Week 12 [N=62; 63; 54] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -0.48 | -1.36 | -1.41 | -1.23 | -1.37 |
,Mirabegron 50 mg | -0.58 | -0.90 | -1.32 | -1.33 | -1.35 |
,Placebo | -0.15 | -0.36 | -0.61 | -0.27 | -0.31 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=9; 18; 13] | Change from Baseline at Week 4 [N=9; 18; 13 | Change from Baseline at Week 8 [N=9; 17; 13] | Change from Baseline at Week 12 [N=9; 17; 13] | Change from Baseline at EOT [N=9; 18; 13] |
---|
Mirabegron 100 mg | -0.97 | -1.60 | -2.31 | -2.03 | -1.98 |
,Mirabegron 50 mg | -0.18 | -0.42 | -0.70 | -0.91 | -0.89 |
,Placebo | -1.16 | -0.99 | -0.77 | -0.98 | -0.96 |
[back to top]
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate." (NCT00410514)
Timeframe: Baseline and Weeks 1, 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Change from Baseline at Week 1 [N=63; 63; 57] | Change from Baseline at Week 4 [N=63; 62; 58] | Change from Baseline at Week 8 [N=62; 63; 56] | Change from Baseline at Week 12 [N=58; 61; 52] | Change from Baseline at EOT [N=63; 64; 58] |
---|
Mirabegron 100 mg | -0.5 | -2.1 | -2.7 | -2.3 | -2.4 |
,Mirabegron 50 mg | -1.0 | -2.5 | -3.1 | -2.9 | -2.9 |
,Placebo | -0.9 | -2.3 | -3.0 | -3.0 | -2.8 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [N= 430; 421; 408] | Week 8 [N= 393; 393; 389] | Week 12 [N= 382; 377; 374] | Final Visit (LOCF) [N= 432; 425; 411] |
---|
Mirabegron 100 mg | -0.18 | -0.21 | -0.21 | -0.21 |
,Mirabegron 50 mg | -0.12 | -0.17 | -0.18 | -0.19 |
,Placebo | -0.08 | -0.10 | -0.09 | -0.08 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N= 366; 345; 353] | Week 8 [N= 333; 324; 340] | Week 12 [N= 323; 311; 328] | Final Visit (LOCF) [N= 366; 348; 356] |
---|
Mirabegron 100 mg | -0.40 | -0.55 | -0.58 | -0.57 |
,Mirabegron 50 mg | -0.43 | -0.54 | -0.59 | -0.57 |
,Placebo | -0.29 | -0.24 | -0.32 | -0.38 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [N= 176; 165; 156] | Week 8 [N= 159; 154; 152] | Week 12 [N= 152; 145; 147] | Final Visit (LOCF) [N= 176; 166; 159] |
---|
Mirabegron 100 mg | -0.76 | -1.03 | -1.09 | -1.06 |
,Mirabegron 50 mg | -0.77 | -0.96 | -1.04 | -1.03 |
,Placebo | -0.40 | -0.56 | -0.63 | -0.63 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency episodes (Least Squares Mean) |
---|
| Week 4 [N= 430; 420; 408] | Week 8 [N= 393; 392; 389] | Week 12 [N= 382; 376; 374] | Final Visit (LOCF) [N= 432; 424; 411] |
---|
Mirabegron 100 mg | -1.45 | -1.80 | -1.79 | -1.76 |
,Mirabegron 50 mg | -1.03 | -1.58 | -1.63 | -1.57 |
,Placebo | -0.75 | -0.91 | -0.86 | -0.82 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=319; 294; 288] | Week 8 [N=291; 273; 278] | Week 12 [N= 278; 264; 265] | Final Visit (LOCF) [N= 319; 297; 291] |
---|
Mirabegron 100 mg | -1.05 | -1.44 | -1.45 | -1.45 |
,Mirabegron 50 mg | -1.09 | -1.23 | -1.32 | -1.32 |
,Placebo | -0.62 | -0.81 | -0.94 | -0.89 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [ N= 354; 346; 335] | Week 8 [N= 325; 321; 323] | Week 12 [N=315; 308; 317] | Final Visit (LOCF) [N= 356; 350; 344] |
---|
Mirabegron 100 mg | -16.1 | -20.3 | -20.7 | -20.2 |
,Mirabegron 50 mg | -13.5 | -16.0 | -17.4 | -17.0 |
,Placebo | -9.7 | -11.6 | -11.3 | -10.8 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 100 mg | 250 | 33 | 0 | 1 | 46 | 75 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 250 | 36 | 1 | 1 | 48 | 71 | 1 | 2 | 2 | 9 | 0 | 0 | 4 | 0 | 0 | 0 |
,Placebo | 239 | 30 | 2 | 4 | 58 | 76 | 7 | 3 | 1 | 5 | 7 | 0 | 1 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Confined to bed | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Confined to bed | Some problems -> Missing data | Confined -> No problems | Confined -> Some problems | Confined -> Confined to bed | Confined -> Missing data | Missing data -> No problems | Missing data -> Some problems | Missing data -> Confined to bed | Missing data -> Missing data |
---|
Mirabegron 100 mg | 291 | 24 | 0 | 1 | 41 | 54 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 304 | 17 | 0 | 2 | 37 | 58 | 0 | 1 | 1 | 0 | 1 | 0 | 3 | 1 | 0 | 0 |
,Placebo | 318 | 15 | 0 | 6 | 41 | 49 | 0 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain -> No pain | No pain -> Moderate pain | No pain -> Extreme pain | No pain -> Missing data | Moderate pain -> No pain | Moderate pain -> Moderate pain | Moderate pain -> Extreme pain | Moderate pain -> Missing data | Extreme pain -> No pain | Extreme pain -> Moderate pain | Extreme pain -> Extreme pain | Extreme pain -> Missing data | Missing data -> No pain | Missing data -> Moderate pain | Missing data -> Extreme pain | Missing data -> Missing data |
---|
Mirabegron 100 mg | 204 | 31 | 1 | 1 | 57 | 95 | 8 | 0 | 3 | 5 | 6 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 198 | 32 | 1 | 2 | 79 | 84 | 9 | 1 | 2 | 8 | 6 | 0 | 2 | 1 | 0 | 0 |
,Placebo | 201 | 34 | 1 | 3 | 76 | 92 | 3 | 3 | 3 | 7 | 8 | 1 | 1 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problems | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 100 mg | 386 | 6 | 1 | 2 | 8 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
,Mirabegron 50 mg | 392 | 9 | 0 | 3 | 8 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
,Placebo | 398 | 10 | 1 | 6 | 7 | 5 | 0 | 1 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable | Some problems -> Missing data | Unable -> No problems | Unable -> Some problems | Unable -> Unable | Unable -> Missing data | Missing data -> No problems | Missing data -> Some problems | Missing data -> Unable | Missing data -> Missing data |
---|
Mirabegron 100 mg | 287 | 19 | 1 | 1 | 50 | 48 | 2 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 297 | 19 | 1 | 2 | 45 | 50 | 1 | 1 | 0 | 5 | 1 | 0 | 2 | 1 | 0 | 0 |
,Placebo | 303 | 22 | 0 | 6 | 47 | 52 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=373; 376; 371] | Final Visit (LOCF) [N=392; 388; 377] |
---|
Mirabegron 100 mg | -0.8 | -0.8 |
,Mirabegron 50 mg | -0.7 | -0.7 |
,Placebo | -0.6 | -0.5 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N= 371; 375; 368] | Final Visit (LOCF) [N= 390; 387; 373] |
---|
Mirabegron 100 mg | 2.09 | 2.09 |
,Mirabegron 50 mg | 1.57 | 1.55 |
,Placebo | 0.72 | 0.70 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | percent activity impairment (Mean) |
---|
| Week 12 [N= 368; 368; 363] | Final Visit (LOCF) [N= 386; 380; 368] |
---|
Mirabegron 100 mg | -10.8 | -10.7 |
,Mirabegron 50 mg | -12.9 | -12.3 |
,Placebo | -7.5 | -6.7 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | percent impairment while working (Mean) |
---|
| Week 12 [N= 142; 143; 137] | Final Visit (LOCF) [N= 147; 146; 137] |
---|
Mirabegron 100 mg | -8.2 | -8.2 |
,Mirabegron 50 mg | -8.5 | -8.6 |
,Placebo | -7.1 | -6.2 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | percent overall work impairment (Mean) |
---|
| Week 12 [ N= 135; 138; 130] | Final Visit (LOCF) [N= 140; 140; 130] |
---|
Mirabegron 100 mg | -8.7 | -8.7 |
,Mirabegron 50 mg | -8.2 | -8.2 |
,Placebo | -7.1 | -6.1 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Week12
Intervention | percent work time missed (Mean) |
---|
| Week 12 [N= 136; 138; 131] | Final Visit (LOCF) [N= 141; 140; 131] |
---|
Mirabegron 100 mg | -1.3 | -1.3 |
,Mirabegron 50 mg | -0.2 | -0.2 |
,Placebo | 0.03 | 0.3 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 [N=433; 421; 409] | Week 8 [N=394; 394; 391] | Week 12 [N=382; 378; 376] |
---|
Mirabegron 100 mg | 19.2 | 19.4 | 18.7 |
,Mirabegron 50 mg | 15.2 | 19.0 | 19.7 |
,Placebo | 7.1 | 5.4 | 7.2 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Mean) |
---|
| Week 4 [N= 413; 406; 396] | Week 8 [N= 385; 385; 387] | Week 12 [N= 377; 369; 378] | Final Visit (LOCF) [N=424; 417; 410] |
---|
Mirabegron 100 mg | 0.52 | 2.34 | 3.89 | 3.52 |
,Mirabegron 50 mg | 0.85 | 2.17 | 3.60 | 3.04 |
,Placebo | -0.57 | 1.15 | 1.92 | 1.46 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12 (Final Visit)
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.13 |
Mirabegron 50 mg | -1.47 |
Mirabegron 100 mg | -1.63 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 8 and 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
| Week 8 [N= 296; 288; 279] | Week 12 [N=283; 278; 267] |
---|
Mirabegron 100 mg | -1.61 | -1.60 |
,Mirabegron 50 mg | -1.32 | -1.45 |
,Placebo | -0.93 | -1.13 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Weeks 8 and 12
Intervention | Micturitions (Least Squares Mean) |
---|
| Week 8 [N=394; 394; 391] | Week 12 [N=382; 379; 376] |
---|
Mirabegron 100 mg | -1.74 | -1.72 |
,Mirabegron 50 mg | -1.52 | -1.71 |
,Placebo | -0.94 | -1.02 |
[back to top]
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00662909)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Percentage of participants (Number) |
---|
| Week 4 [N= 325; 309; 293] | Week 8 [N= 296; 288; 279] | Week 12 [N= 283; 278; 267] | Final Visit (LOCF) [N= 325; 312; 296] |
---|
Mirabegron 100 mg | 59.0 | 73.8 | 74.5 | 73.3 |
,Mirabegron 50 mg | 56.6 | 61.8 | 68.7 | 66.7 |
,Placebo | 48.0 | 52.0 | 61.5 | 59.4 |
[back to top]
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | Percentage of participants (Number) |
---|
| Improvement at Week 12 [N= 373; 376; 371] | Improvement at Final Visit [N= 392; 388; 377] | Major Improvement at Week 12 [N= 373; 376; 371] | Major Improvement at Final Visit [N=392; 388; 377] |
---|
Mirabegron 100 mg | 57.1 | 56.8 | 27.8 | 27.3 |
,Mirabegron 50 mg | 50.8 | 50.8 | 18.6 | 18.6 |
,Placebo | 48.3 | 47.4 | 17.7 | 17.3 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00662909)
Timeframe: Weeks 4, 8 and 12
Intervention | Percentage of participants (Number) |
---|
| Week 4 [N= 325; 309; 293] | Week 8 [N= 296; 288; 279] | Week 12 [N=283; 278; 267] | Final Visit (LOCF) [N= 325; 312; 296] |
---|
Mirabegron 100 mg | 32.8 | 43.4 | 48.7 | 49.0 |
,Mirabegron 50 mg | 30.1 | 35.4 | 42.8 | 40.7 |
,Placebo | 26.8 | 29.4 | 35.0 | 33.8 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | Micturitions (Least Squares Mean) |
---|
Placebo | -1.05 |
Mirabegron 50 mg | -1.66 |
Mirabegron 100 mg | -1.75 |
[back to top]
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 7.0 |
Mirabegron 50 mg | 18.2 |
Mirabegron 100 mg | 18.0 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 4
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.72 |
Mirabegron 50 mg | -1.20 |
Mirabegron 100 mg | -1.18 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00662909)
Timeframe: Baseline and Week 4
Intervention | Micturitions (Least Squares Mean) |
---|
Placebo | -0.77 |
Mirabegron 50 mg | -1.19 |
Mirabegron 100 mg | -1.37 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 100 mg | 453 | 34 | 3 | 1 | 99 | 181 | 9 | 2 | 5 | 9 | 5 | 0 | 0 | 1 | 0 | 0 |
,Mirabegron 50 mg | 413 | 43 | 3 | 3 | 108 | 174 | 7 | 1 | 3 | 8 | 15 | 0 | 7 | 4 | 0 | 0 |
,Tolterodine ER 4 mg | 429 | 43 | 1 | 2 | 105 | 169 | 11 | 2 | 3 | 14 | 6 | 0 | 3 | 2 | 1 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Confined to bed | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Confined to bed | Some problems -> Missing data | Confined to bed -> No problems | Confined to bed -> Some problems | Confined to bed -> Confined to bed | Confined to bed -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Confined to bed | Missing data -> Missing data |
---|
Mirabegron 100 mg | 601 | 42 | 1 | 3 | 55 | 97 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 567 | 36 | 1 | 4 | 64 | 105 | 1 | 0 | 0 | 0 | 0 | 0 | 11 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 573 | 39 | 0 | 2 | 62 | 106 | 0 | 2 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No pain -> No pain | No pain -> Moderate pain | No pain -> Extreme pain | No pain -> Missing data | Moderate pain -> No pain | Moderate pain -> Moderate pain | Moderate pain -> Extreme pain | Moderate pain -> Missing data | Extreme pain -> No pain | Extreme pain -> Moderate pain | Extreme pain -> Extreme pain | Extreme pain -> Missing data | Missing data-> No pain | Missing data -> Moderate pain | Missing data -> Extreme pain | Missing data -> Missing data |
---|
Mirabegron 100 mg | 396 | 69 | 2 | 2 | 107 | 196 | 5 | 2 | 4 | 6 | 10 | 0 | 3 | 0 | 0 | 0 |
,Mirabegron 50 mg | 398 | 54 | 4 | 4 | 104 | 173 | 14 | 1 | 3 | 13 | 10 | 0 | 8 | 3 | 0 | 0 |
,Tolterodine ER 4 mg | 398 | 63 | 4 | 2 | 105 | 182 | 8 | 2 | 4 | 9 | 8 | 0 | 6 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 100 mg | 735 | 15 | 0 | 4 | 19 | 25 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 718 | 16 | 1 | 4 | 19 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 720 | 23 | 3 | 4 | 13 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to perform usual activities | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems-> Unable to perform usual activities | Some problems -> Missing data | Unable to perform usual activities -> No problems | Unable to perform usual activities-> Some problems | Unable to perform -> Unable to perform | Unable to perform usual activities -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to perform usual activities | Missing data -> Missing data |
---|
Mirabegron 100 mg | 569 | 55 | 1 | 1 | 88 | 76 | 2 | 2 | 2 | 4 | 0 | 2 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 536 | 40 | 2 | 3 | 97 | 94 | 1 | 1 | 0 | 2 | 2 | 10 | 1 | 0 | 0 | 0 |
,Tolterodine ER 4 mg | 542 | 53 | 2 | 1 | 96 | 79 | 1 | 3 | 0 | 5 | 1 | 7 | 1 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 12 [N=601; 616; 611] | Final Visit (LOCF) [N=655; 673; 673] |
---|
Mirabegron 100 mg | -0.9 | -0.9 |
,Mirabegron 50 mg | -0.8 | -0.8 |
,Tolterodine ER 4 mg | -0.9 | -0.8 |
[back to top]
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 12 [N=599; 620; 613] | Final Visit (LOCF) [N=654; 676; 676] |
---|
Mirabegron 100 mg | 2.27 | 2.11 |
,Mirabegron 50 mg | 2.27 | 2.08 |
,Tolterodine ER 4 mg | 2.52 | 2.27 |
[back to top]
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 1 [N=784; 793; 780] | Month 3 [N=739; 738; 733] | Month 6 [N=684; 702; 680] | Month 9 [N=654; 666; 643] | Month 12 [N=622; 638; 621] | Final Visit (LOCF) [N=789; 801; 788] |
---|
Mirabegron 100 mg | -0.19 | -0.28 | -0.32 | -0.30 | -0.31 | -0.29 |
,Mirabegron 50 mg | -0.18 | -0.21 | -0.29 | -0.30 | -0.33 | -0.29 |
,Tolterodine ER 4 mg | -0.17 | -0.24 | -0.27 | -0.31 | -0.32 | -0.27 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | -1.03 | -1.28 | -1.27 | -1.32 | -1.19 | -1.24 |
,Mirabegron 50 mg | -0.94 | -1.10 | -1.11 | -1.17 | -1.14 | -1.01 |
,Tolterodine ER 4 mg | -0.96 | -1.09 | -1.17 | -1.26 | -1.36 | -1.26 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Month 1 [N=786; 797; 786] | Month 3 [N=742; 741; 735] | Month 6 [N=684; 705; 684] | Month 9 [N=656; 667; 645] | Month 12 [N=627; 642; 623] | Final Visit (LOCF) [N=789; 802; 791] |
---|
Mirabegron 100 mg | -1.10 | -1.46 | -1.43 | -1.37 | -1.46 | -1.41 |
,Mirabegron 50 mg | -0.94 | -1.13 | -1.25 | -1.33 | -1.30 | -1.27 |
,Tolterodine ER 4 mg | -1.02 | -1.27 | -1.30 | -1.38 | -1.50 | -1.39 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 [N=690; 698; 690] | Month 3 [N=654; 651; 643] | Month 6 [N=604; 618; 602] | Month 9 [N=580; 583; 567] | Month 12 [N=554; 562; 550] | Final Visit (LOCF) [N=693; 703; 693] |
---|
Mirabegron 100 mg | -0.29 | -0.45 | -0.38 | -0.41 | -0.40 | -0.39 |
,Mirabegron 50 mg | -0.26 | -0.41 | -0.42 | -0.50 | -0.48 | -0.46 |
,Tolterodine ER 4 mg | -0.29 | -0.37 | -0.35 | -0.39 | -0.46 | -0.43 |
[back to top]
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent work time missed (Mean) |
---|
| Month 3 [N=215; 217; 211] | Month 6 [N=183; 203; 200] | Month 12 [N=181; 185; 188] | Final Visit (LOCF) [N=245; 256; 249] |
---|
Mirabegron 100 mg | -1.0 | -1.5 | -0.8 | -0.9 |
,Mirabegron 50 mg | -0.06 | -1.3 | -0.5 | -0.5 |
,Tolterodine ER 4 mg | -0.6 | -0.7 | -1.2 | -0.8 |
[back to top]
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent overall work impairment (Mean) |
---|
| Month 3 [N=208; 208; 204] | Month 6 [N=181; 195; 193] | Month 12 [N=175; 177; 183] | Final Visit (LOCF) [N=240; 250; 244] |
---|
Mirabegron 100 mg | -10.9 | -13.0 | -14.1 | -12.4 |
,Mirabegron 50 mg | -11.4 | -12.4 | -11.5 | -11.2 |
,Tolterodine ER 4 mg | -11.0 | -11.1 | -13.6 | -11.5 |
[back to top]
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent activity impairment (Mean) |
---|
| Month 3 [N=691; 690; 692] | Month 6 [N=640; 663; 651] | Month 12 [N=582; 603; 598] | Final Visit (LOCF) [N=728; 737; 733] |
---|
Mirabegron 100 mg | -13.7 | -15.6 | -15.2 | -13.9 |
,Mirabegron 50 mg | -12.0 | -14.0 | -13.3 | -12.5 |
,Tolterodine ER 4 mg | -12.3 | -13.4 | -15.0 | -12.8 |
[back to top]
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 3, 6 and 12
Intervention | Percent impairment while working (Mean) |
---|
| Month 3 [N=233; 236; 231] | Month 6 [N=207; 216; 213] | Month 12 [N=194; 196; 201] | Final Visit (LOCF) [N=261; 272; 265] |
---|
Mirabegron 100 mg | -9.9 | -11.9 | -14.4 | -11.8 |
,Mirabegron 50 mg | -10.6 | -13.0 | -11.9 | -10.9 |
,Tolterodine ER 4 mg | -10.9 | -11.1 | -12.3 | -10.6 |
[back to top]
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 [N=324; 305; 313] | Month 3 [N=307; 280; 286] | Month 6 [N=277; 271; 264] | Month 9 [N=264; 255; 250] | Month 12 [N=254; 247; 241] | Final Visit (LOCF) [N=325; 307; 314] |
---|
Mirabegron 100 mg | -0.79 | -0.94 | -0.94 | -0.96 | -0.92 | -0.88 |
,Mirabegron 50 mg | -0.75 | -0.80 | -0.88 | -0.99 | -0.87 | -0.81 |
,Tolterodine ER 4 mg | -0.79 | -0.95 | -0.99 | -0.99 | -1.13 | -1.02 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Mean) |
---|
| Month 1 [N=767; 787; 770] | Month 3 [N=734; 740; 731] | Month 6 [N=676; 697; 678] | Month 9 [N=645; 665; 637] | Month 12 [N=615; 637; 612] | Final Visit (LOCF) [N=776; 797; 777] |
---|
Mirabegron 100 mg | 3.9 | 5.4 | 6.4 | 6.5 | 6.8 | 5.9 |
,Mirabegron 50 mg | 3.8 | 5.0 | 6.5 | 6.6 | 8.2 | 6.8 |
,Tolterodine ER 4 mg | 3.1 | 4.3 | 5.2 | 6.3 | 7.9 | 6.0 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate." (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Month 1 [N=775; 784; 771] | Month 3 [N=736; 733; 739] | Month 6 [N=680; 699; 682] | Month 9 [N=649; 661; 639] | Month 12 [N=622; 636; 612] | Final Visit (LOCF) [N=779; 795; 781] |
---|
Mirabegron 100 mg | -12.5 | -16.1 | -16.5 | -15.6 | -15.7 | -14.8 |
,Mirabegron 50 mg | -10.5 | -13.4 | -14.5 | -14.2 | -14.1 | -13.1 |
,Tolterodine ER 4 mg | -11.5 | -13.5 | -14.6 | -14.3 | -16.3 | -14.3 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | mL (Least Squares Mean) |
---|
| Month 1 [N=785; 797; 786] | Month 3 [N=741; 741; 735] | Month 6 [N=684; 705; 684] | Month 9 [N=655; 667; 645] | Month 12 [N=626; 642; 623] | Final Visit (LOCF) [N=789; 802; 791] |
---|
Mirabegron 100 mg | 16.7 | 20.4 | 23.0 | 23.5 | 24.3 | 21.5 |
,Mirabegron 50 mg | 12.1 | 14.8 | 18.6 | 20.5 | 18.5 | 17.5 |
,Tolterodine ER 4 mg | 16.0 | 17.4 | 18.8 | 17.9 | 18.9 | 18.1 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 [N=471; 467; 471] | Month 3 [N=441; 432; 440] | Month 6 [N=404; 417; 408] | Month 9 [N=382; 392; 382] | Month 12 [N=366; 377; 371] | Final Visit (LOCF) [N=472; 471; 474] |
---|
Mirabegron 100 mg | -1.04 | -1.23 | -1.32 | -1.33 | -1.20 | -1.23 |
,Mirabegron 50 mg | -0.92 | -1.05 | -1.13 | -1.13 | -1.17 | -1.01 |
,Tolterodine ER 4 mg | -0.95 | -1.06 | -1.11 | -1.25 | -1.29 | -1.21 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Month 1 [N=783; 791; 780] | Month 3 [N=738; 737; 733] | Month 6 [N=683; 701; 680] | Month 9 [N=653; 665; 643] | Month 12 [N=621; 637; 621] | Final Visit (LOCF) [N=788; 799; 788] |
---|
Mirabegron 100 mg | -1.31 | -1.83 | -1.95 | -1.71 | -1.79 | -1.80 |
,Mirabegron 50 mg | -1.30 | -1.37 | -1.75 | -1.77 | -1.81 | -1.62 |
,Tolterodine ER 4 mg | -1.11 | -1.55 | -1.63 | -1.78 | -1.89 | -1.63 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00688688)
Timeframe: Months 1, 3, 6, 9 and 12
Intervention | percentage of participants (Number) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | 36.7 | 45.4 | 45.1 | 46.8 | 47.5 | 45.8 |
,Mirabegron 50 mg | 35.4 | 40.9 | 43.3 | 47.5 | 47.8 | 43.4 |
,Tolterodine ER 4 mg | 33.4 | 39.2 | 43.5 | 44.2 | 49.1 | 45.1 |
[back to top]
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. (NCT00688688)
Timeframe: Baseline and Month 12
Intervention | percentage of participants (Number) |
---|
| Improvement: Month12 [N=616; 630; 620] | Improvement: Final Visit [N=671; 688; 684] | Major Improvement: Month 12 [N=616; 630; 620] | Major Improvement: Final Visit [N=671; 688; 684] |
---|
Mirabegron 100 mg | 60.6 | 59.6 | 29.7 | 28.2 |
,Mirabegron 50 mg | 55.7 | 52.9 | 27.4 | 26.2 |
,Tolterodine ER 4 mg | 56.6 | 54.4 | 28.2 | 26.6 |
[back to top]
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00688688)
Timeframe: Baseline and Months 1, 3, 6, 9 and 12
Intervention | percentage of participants (Number) |
---|
| Month 1 [N=478; 479; 485] | Month 3 [N=447; 443; 452] | Month 6 [N=409; 428; 418] | Month 9 [N=387; 402; 391] | Month 12 [N=370; 387; 379] | Final Visit (LOCF) [N=479; 483; 488] |
---|
Mirabegron 100 mg | 57.0 | 66.1 | 66.8 | 67.2 | 68.5 | 66.3 |
,Mirabegron 50 mg | 58.2 | 61.7 | 65.5 | 65.6 | 67.6 | 63.7 |
,Tolterodine ER 4 mg | 56.3 | 61.5 | 63.9 | 66.0 | 71.2 | 66.8 |
[back to top]
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Intervention | participants (Number) |
---|
| Adverse events | Treatment-related adverse events (TRAEs) | Deaths | Serious adverse events (SAEs) | Treatment-related serious adverse events | AEs leading to study drug discontinuation | TRAEs leading to study drug discontinuation |
---|
Mirabegron 100 mg | 503 | 192 | 0 | 51 | 4 | 50 | 29 |
,Mirabegron 50 mg | 485 | 213 | 2 | 42 | 10 | 48 | 35 |
,Tolterodine ER 4 mg | 508 | 224 | 2 | 44 | 5 | 46 | 31 |
[back to top]
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities." (NCT00688688)
Timeframe: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Intervention | participants (Number) |
---|
| Mild adverse events | Moderate adverse events | Severe adverse events |
---|
Mirabegron 100 mg | 240 | 211 | 52 |
,Mirabegron 50 mg | 222 | 212 | 51 |
,Tolterodine ER 4 mg | 251 | 218 | 39 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=476; 469; 472; 471] | Week 8 [N=460; 447; 451; 456] | Week 12 [N=450; 434; 442; 434] | Final Visit (LOCF) [N=480; 472; 475; 473] |
---|
Mirabegron 100 mg | -0.21 | -0.27 | -0.31 | -0.30 |
,Mirabegron 50 mg | -0.19 | -0.26 | -0.33 | -0.31 |
,Placebo | -0.08 | -0.16 | -0.22 | -0.22 |
,Tolterodine SR 4 mg | -0.21 | -0.25 | -0.30 | -0.29 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N=428; 422; 422; 432] | Week 8 [N=414; 404; 403; 419] | Week 12 [N=404; 393; 395; 399] | Final Visit (LOCF) [N=428; 423; 422; 433] |
---|
Mirabegron 100 mg | -0.34 | -0.48 | -0.47 | -0.50 |
,Mirabegron 50 mg | -0.27 | -0.41 | -0.57 | -0.56 |
,Placebo | -0.25 | -0.30 | -0.41 | -0.41 |
,Tolterodine SR 4 mg | -0.29 | -0.39 | -0.44 | -0.45 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [N=209; 183; 195; 181] | Week 8 [N=204; 176; 183; 177] | Week 12 [N=200; 172; 181; 165] | Final Visit (LOCF) [N=209; 183; 195; 181] |
---|
Mirabegron 100 mg | -0.81 | -1.03 | -1.11 | -1.12 |
,Mirabegron 50 mg | -0.73 | -1.02 | -1.26 | -1.17 |
,Placebo | -0.45 | -0.72 | -0.99 | -0.95 |
,Tolterodine SR 4 mg | -0.67 | -0.77 | -0.95 | -0.95 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency episodes (Least Squares Mean) |
---|
| Week 4 [N=475; 469; 471; 470] | Week 8 [N=460; 446; 450; 456] | Week 12 [N=450; 433; 441; 434] | Final Visit (LOCF) [N=479; 470; 474; 472] |
---|
Mirabegron 100 mg | -1.54 | -1.90 | -2.00 | -1.96 |
,Mirabegron 50 mg | -1.39 | -1.90 | -2.35 | -2.25 |
,Placebo | -0.89 | -1.28 | -1.65 | -1.65 |
,Tolterodine SR 4 mg | -1.63 | -1.91 | -2.16 | -2.07 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=283; 286; 276; 288] | Week 8 [N=273; 272; 263; 281] | Week 12 [N=269; 267; 257; 265] | Final Visit (LOCF) [N=283; 286; 276; 289] |
---|
Mirabegron 100 mg | -1.00 | -1.32 | -1.32 | -1.33 |
,Mirabegron 50 mg | -0.98 | -1.27 | -1.52 | -1.46 |
,Placebo | -0.63 | -0.94 | -1.12 | -1.11 |
,Tolterodine SR 4 mg | -1.01 | -0.99 | -1.19 | -1.18 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=472; 460; 470; 467] | Week 8 [N=455; 441; 450; 451] | Week 12 [N=445; 424; 435; 433] | Final Visit (LOCF) [N=475; 465; 473; 469] |
---|
Mirabegron 100 mg | -13.8 | -17.6 | -20.0 | -19.9 |
,Mirabegron 50 mg | -13.0 | -17.8 | -20.3 | -19.6 |
,Placebo | -9.7 | -13.3 | -15.3 | -14.9 |
,Tolterodine SR 4 mg | -13.8 | -17.1 | -18.5 | -18.4 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Scores on a scale (Mean) |
---|
| Week 4 [N=466; 459; 468; 461] | Week 8 [N=451; 443; 447; 447] | Week 12 [N=443; 423; 437; 429] | Final Visit (LOCF) [N=470; 466; 472; 467] |
---|
Mirabegron 100 mg | 4.4 | 6.8 | 8.2 | 8.1 |
,Mirabegron 50 mg | 3.3 | 5.5 | 7.1 | 6.5 |
,Placebo | 3.1 | 4.5 | 6.7 | 6.4 |
,Tolterodine SR 4 mg | 3.2 | 6.0 | 6.9 | 6.4 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
| Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] |
---|
Mirabegron 100 mg | -1.40 | -1.45 |
,Mirabegron 50 mg | -1.29 | -1.62 |
,Placebo | -1.00 | -1.18 |
,Tolterodine SR 4 mg | -1.02 | -1.27 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 8 [N=463; 450; 455; 461] | Week 12 [N=452; 437; 447; 438] |
---|
Mirabegron 100 mg | -1.66 | -1.78 |
,Mirabegron 50 mg | -1.64 | -2.02 |
,Placebo | -1.15 | -1.33 |
,Tolterodine SR 4 mg | -1.43 | -1.60 |
[back to top]
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=291; 293; 281; 299] | Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] | Final Visit (LOCF) [N=291; 293; 281; 300] |
---|
Mirabegron 100 mg | 54.4 | 68.3 | 67.9 | 67.6 |
,Mirabegron 50 mg | 57.3 | 67.9 | 73.5 | 72.2 |
,Placebo | 46.0 | 53.9 | 61.5 | 60.1 |
,Tolterodine SR 4 mg | 56.5 | 64.4 | 69.6 | 68.3 |
[back to top]
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
| Improvement: Week 12 [N=425; 410;421; 417] | Improvement: Final Visit [N=433; 416; 429; 426] | Major Improvement: Week 12 [N=425; 410; 421; 417] | Major Improvement: Final Visit [N=433;416;429;426] |
---|
Mirabegron 100 mg | 62.7 | 62.2 | 34.0 | 33.6 |
,Mirabegron 50 mg | 61.5 | 61.3 | 29.5 | 29.1 |
,Placebo | 56.9 | 56.6 | 28.5 | 28.2 |
,Tolterodine SR 4 mg | 65.2 | 65.0 | 31.7 | 31.5 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.34 |
Mirabegron 50 mg | -1.93 |
Mirabegron 100 mg | -1.77 |
Tolterodine SR 4 mg | -1.59 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12 (final visit)
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.17 |
Mirabegron 50 mg | -1.57 |
Mirabegron 100 mg | -1.46 |
Tolterodine SR 4 mg | -1.27 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00689104)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=291; 293; 281; 299] | Week 8 [N=280; 277; 268; 292] | Week 12 [N=275; 272; 262; 276] | Final Visit (LOCF) [N=291; 293; 281; 300] |
---|
Mirabegron 100 mg | 32.0 | 45.1 | 43.9 | 43.8 |
,Mirabegron 50 mg | 32.1 | 42.6 | 46.3 | 45.1 |
,Placebo | 28.9 | 34.3 | 41.1 | 40.5 |
,Tolterodine SR 4 mg | 33.4 | 41.8 | 48.6 | 47.3 |
[back to top]
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 12.3 |
Mirabegron 50 mg | 24.2 |
Mirabegron 100 mg | 25.6 |
Tolterodine SR 4 mg | 25.0 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.65 |
Mirabegron 50 mg | -1.04 |
Mirabegron 100 mg | -1.03 |
Tolterodine SR 4 mg | -1.00 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Week 4
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -0.77 |
Mirabegron 50 mg | -1.16 |
Mirabegron 100 mg | -1.29 |
Tolterodine SR 4 mg | -1.10 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Confined to bed | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Confined to bed | Some problems -> Missing data | Confined -> No problems | Confined -> Some problems | Confined -> Confined to bed | Confined -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Confined to bed | Missing data -> Missing data |
---|
Mirabegron 100 mg | 334 | 18 | 0 | 1 | 40 | 82 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 340 | 26 | 1 | 2 | 44 | 59 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 334 | 27 | 0 | 2 | 37 | 78 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,Tolterodine SR 4 mg | 330 | 28 | 0 | 1 | 38 | 73 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain -> No pain | No pain -> Moderate pain | No pain -> Extreme pain | No pain -> Missing data | Moderate pain -> No pain | Moderate pain -> Moderate pain | Moderate pain -> Extreme pain | Moderate pain ->Missing data | Extreme pain -> No pain | Extreme pain -> Moderate pain | Extreme pain -> Extreme pain | Extreme pain -> Missing data | Missing data -> No pain | Missing data -> Moderate pain | Missing data -> Extreme pain | Missing data -> Missing data |
---|
Mirabegron 100 mg | 209 | 50 | 2 | 1 | 76 | 114 | 5 | 1 | 1 | 12 | 5 | 0 | 1 | 1 | 0 | 0 |
,Mirabegron 50 mg | 211 | 32 | 2 | 2 | 71 | 128 | 8 | 0 | 2 | 12 | 4 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 210 | 36 | 4 | 0 | 70 | 129 | 2 | 2 | 3 | 13 | 10 | 0 | 0 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 197 | 37 | 2 | 1 | 69 | 132 | 7 | 0 | 4 | 12 | 9 | 0 | 3 | 1 | 1 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 100 mg | 439 | 17 | 0 | 2 | 8 | 10 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 445 | 9 | 0 | 2 | 9 | 6 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,Placebo | 437 | 7 | 0 | 2 | 18 | 14 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Tolterodine SR 4 mg | 432 | 12 | 1 | 1 | 9 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to perform usual activities | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems-> Unable to perform usual activities | Some problems -> Missing data | Unable to perform usual activities -> No problems | Unable to perform usual activities-> Some problems | Unable to perform -> Unable to perform | Unable to perform usual activities -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to perform usual activities | Missing data -> Missing data |
---|
Mirabegron 100 mg | 327 | 25 | 3 | 1 | 51 | 63 | 0 | 1 | 1 | 3 | 2 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 316 | 18 | 2 | 1 | 82 | 48 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
,Placebo | 298 | 25 | 0 | 2 | 73 | 75 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 283 | 39 | 0 | 1 | 68 | 73 | 0 | 0 | 2 | 3 | 1 | 0 | 4 | 1 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 100 mg | 232 | 19 | 1 | 2 | 88 | 105 | 10 | 0 | 1 | 11 | 8 | 0 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 224 | 30 | 1 | 0 | 74 | 111 | 5 | 1 | 4 | 12 | 9 | 1 | 1 | 0 | 0 | 0 |
,Placebo | 219 | 37 | 2 | 1 | 76 | 108 | 9 | 1 | 3 | 12 | 9 | 0 | 2 | 1 | 0 | 0 |
,Tolterodine SR 4 mg | 217 | 21 | 3 | 0 | 71 | 122 | 12 | 1 | 4 | 18 | 2 | 0 | 3 | 1 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=425; 410; 421; 417] | Final Visit (LOCF) [N=433; 416; 429; 426] |
---|
Mirabegron 100 mg | -0.1 | -1.1 |
,Mirabegron 50 mg | -1.1 | -1.0 |
,Placebo | -0.8 | -0.8 |
,Tolterodine SR 4 mg | -1.0 | -1.0 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=421; 410; 420; 416] | Final Visit (LOCF) [N=428; 414; 427; 425] |
---|
Mirabegron 100 mg | 2.67 | 2.66 |
,Mirabegron 50 mg | 2.57 | 2.55 |
,Placebo | 1.92 | 1.89 |
,Tolterodine SR 4 mg | 2.44 | 2.44 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent activity impairment (Mean) |
---|
| Week 12 [N=409; 395; 409; 400] | Final Visit (LOCF) [N=419; 400; 417; 409] |
---|
Mirabegron 100 mg | -14.5 | -14.4 |
,Mirabegron 50 mg | -15.0 | -14.9 |
,Placebo | -11.2 | -11.0 |
,Tolterodine SR 4 mg | -14.7 | -14.3 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent impairment while working (Mean) |
---|
| Week 12 [N=116; 128; 104; 114] | Final Visit (LOCF) [N=118; 130; 106; 115] |
---|
Mirabegron 100 mg | -10.8 | -10.8 |
,Mirabegron 50 mg | -12.5 | -12.8 |
,Placebo | -8.3 | -8.1 |
,Tolterodine SR 4 mg | -6.7 | -6.6 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent overall work impairment (Mean) |
---|
| Week 12 [N=104; 117; 98; 104] | Final Visit (LOCF) [N=106; 119; 99; 105] |
---|
Mirabegron 100 mg | -11.6 | -11.5 |
,Mirabegron 50 mg | -13.2 | -13.6 |
,Placebo | -7.9 | -7.7 |
,Tolterodine SR 4 mg | -5.8 | -5.8 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00689104)
Timeframe: Baseline and Week 12
Intervention | percent work time missed (Mean) |
---|
| Week 12 [N=111; 120; 109; 113] | Final Visit (LOCF) [N=113; 122; 110; 114] |
---|
Mirabegron 100 mg | -1.7 | -1.7 |
,Mirabegron 50 mg | -1.9 | -1.8 |
,Placebo | -0.2 | -0.2 |
,Tolterodine SR 4 mg | -1.2 | -1.2 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00689104)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 [N=479; 470; 477; 474] | Week 8 [N=463; 449; 455; 461] | Week 12 [N=452; 437; 447; 438] |
---|
Mirabegron 100 mg | 20.3 | 25.3 | 25.7 |
,Mirabegron 50 mg | 20.1 | 20.7 | 25.3 |
,Placebo | 9.8 | 11.7 | 11.9 |
,Tolterodine SR 4 mg | 21.4 | 25.9 | 25.8 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 8 [N= 377; 395; 399] | Week 12 [N= 366; 387; 386] |
---|
Mirabegron 25 mg | -1.52 | -1.68 |
,Mirabegron 50 mg | -1.53 | -1.69 |
,Placebo | -1.09 | -1.47 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Confined to bed | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Confined to bed | Some problems -> Missing data | Confined -> No problems | Confined -> Some problems | Confined -> Confined to bed | Confined -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Confined to bed | Missing data -> Missing data |
---|
Mirabegron 25 mg | 310 | 20 | 0 | 1 | 31 | 45 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
,Mirabegron 50 mg | 304 | 33 | 0 | 2 | 36 | 48 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 327 | 16 | 0 | 6 | 22 | 39 | 0 | 1 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Not anxious -> Not anxious | Not anxious -> Moderately anxious | Not anxious -> Extremely anxious | Not anxious -> Missing data | Moderately anxious -> Not anxious | Moderately anxious -> Moderately anxious | Moderately anxious -> Extremely anxious | Moderately anxious -> Missing data | Extremely anxious -> Not anxious | Extremely anxious -> Moderately anxious | Extremely anxious -> Extremely anxious | Extremely anxious -> Missing data | Missing data -> Not anxious | Missing data -> Moderately anxious | Missing data -> Extremely anxious | Missing data -> Missing data |
---|
Mirabegron 25 mg | 243 | 29 | 1 | 0 | 50 | 74 | 2 | 0 | 1 | 5 | 1 | 1 | 2 | 1 | 0 | 0 |
,Mirabegron 50 mg | 225 | 33 | 3 | 4 | 58 | 89 | 3 | 0 | 2 | 6 | 3 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 239 | 20 | 1 | 3 | 52 | 77 | 4 | 4 | 1 | 6 | 4 | 0 | 3 | 1 | 0 | 0 |
[back to top]
Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes
Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 44.6 |
Mirabegron 25 mg | 47.1 |
Mirabegron 50 mg | 57.7 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 4
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -0.78 |
Mirabegron 25 mg | -0.96 |
Mirabegron 50 mg | -1.14 |
[back to top]
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 4
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.62 |
Mirabegron 25 mg | -0.96 |
Mirabegron 50 mg | -1.13 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 8.3 |
Mirabegron 25 mg | 12.8 |
Mirabegron 50 mg | 20.7 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.95 |
Mirabegron 25 mg | -1.31 |
Mirabegron 50 mg | -1.33 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | urgency episodes (Least Squares Mean) |
---|
Placebo | -1.35 |
Mirabegron 25 mg | -1.68 |
Mirabegron 50 mg | -1.94 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.18 |
Mirabegron 25 mg | -1.65 |
Mirabegron 50 mg | -1.60 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.96 |
Mirabegron 25 mg | -1.36 |
Mirabegron 50 mg | -1.38 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=256; 247; 249] | Week 8 [N=231; 237; 236] | Week 12 [N=226; 232; 227] |
---|
Mirabegron 25 mg | -0.98 | -1.33 | -1.32 |
,Mirabegron 50 mg | -1.12 | -1.39 | -1.39 |
,Placebo | -0.63 | -1.02 | -1.06 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 [N=415; 410; 424] | Week 8 [N=377; 395; 399] | Week 12 [N=366; 387; 386] |
---|
Mirabegron 25 mg | 10.6 | 15.7 | 13.6 |
,Mirabegron 50 mg | 17.8 | 17.9 | 22.5 |
,Placebo | 7.6 | 9.8 | 8.2 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N=362; 362; 376] | Week 8 [N=329; 349; 354] | Week 12 [N=321; 342; 344] | Final Visit (LOCF) [N=362; 362; 378] |
---|
Mirabegron 25 mg | -0.27 | -0.41 | -0.50 | -0.49 |
,Mirabegron 50 mg | 0.38 | -0.44 | -0.52 | -0.52 |
,Placebo | -0.30 | -0.45 | -0.54 | -0.48 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [N=145; 136; 136] | Week 8 [N=131; 131; 128] | Week 12 [N=129; 129; 124] | Final Visit (LOCF) [N=145; 136; 137] |
---|
Mirabegron 25 mg | -0.59 | -0.79 | -0.89 | -0.83 |
,Mirabegron 50 mg | -0.81 | -1.16 | -1.17 | -1.16 |
,Placebo | -0.72 | -0.97 | -1.06 | -0.99 |
[back to top]
Percentage of Responders for Mean Level of Urgency
Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence). (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 36.6 |
Mirabegron 25 mg | 40.5 |
Mirabegron 50 mg | 44.8 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate." (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=402; 406; 418] | Week 8 [N=376; 389; 391] | Week 12 [N=360; 380; 378] | Final Visit (LOCF) [N=405; 407; 422] |
---|
Mirabegron 25 mg | -13.7 | -17.4 | -18.0 | -17.9 |
,Mirabegron 50 mg | -12.7 | -18.5 | -19.6 | -18.8 |
,Placebo | -12.2 | -15.1 | -17.5 | -16.0 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Mean) |
---|
| Week 4 [N=399; 401; 411] | Week 8 [N=368; 386; 383] | Week 12 [N=359; 379; 375] | Final Visit (LOCF) [N=404; 406; 419] |
---|
Mirabegron 25 mg | 2.43 | 3.95 | 4.40 | 4.12 |
,Mirabegron 50 mg | 1.67 | 4.13 | 5.59 | 4.96 |
,Placebo | 0.38 | 3.14 | 4.26 | 3.43 |
[back to top]
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 8 and 12
Intervention | Incontinence episodes (Least Squares Mean) |
---|
| Week 8 [N= 236; 244; 241] | Week 12 [N= 231; 239; 232] |
---|
Mirabegron 25 mg | -1.38 | -1.36 |
,Mirabegron 50 mg | -1.39 | -1.43 |
,Placebo | -1.04 | -1.08 |
[back to top]
Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
Placebo | -0.15 |
Mirabegron 25 mg | -0.22 |
Mirabegron 50 mg | -0.29 |
[back to top]
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=262; 254; 255] | Week 8 [N=236; 244; 241] | Week 12 [N=231; 239; 232] | Final Visit (LOCF) [N=262; 254; 257] |
---|
Mirabegron 25 mg | 54.7 | 71.7 | 74.1 | 72.8 |
,Mirabegron 50 mg | 61.6 | 71.4 | 71.1 | 70.0 |
,Placebo | 46.6 | 62.7 | 61.5 | 59.2 |
[back to top]
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
| Improvement: Week 12 [N=357; 381; 378] | Improvement: Final Visit [N=376; 391; 395] | Major Improvement: Week 12 [N=357; 381; 378] | Major Improvement: Final Visit [N=376; 391; 395] |
---|
Mirabegron 25 mg | 52.8 | 52.7 | 23.6 | 23.0 |
,Mirabegron 50 mg | 55.8 | 55.2 | 25.7 | 25.6 |
,Placebo | 56.0 | 55.1 | 22.1 | 21.5 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. (NCT00912964)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=262; 254; 255] | Week 8 [N=236; 244; 241] | Week 12 [N=231; 239; 232] | Final Visit (LOCF) [N=262; 254; 257] |
---|
Mirabegron 25 mg | 31.5 | 44.7 | 46.9 | 45.7 |
,Mirabegron 50 mg | 36.5 | 41.9 | 47.4 | 47.1 |
,Placebo | 28.2 | 41.9 | 42.0 | 39.7 |
[back to top]
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale
The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Baseline: Total | Baseline: Very Much Improved | Baseline: Much Improved | Baseline: Minimally Improved | Baseline: No Change | Baseline: Minimally Worse | Baseline: Much Worse | Baseline: Very Much Worse | Week 12: Total | Week 12: Very Much Improved | Week 12: Much Improved | Week 12: Minimally Improved | Week 12: No Change | Week 12: Minimally Worse | Week 12: Much Worse | Week 12: Very Much Worse | Final Visit: Total | Final Visit: Very Much Improved | Final Visit: Much Improved | Final Visit: Minimally Improved | Final Visit: No Change | Final Visit: Minimally Worse | Final Visit: Much Worse | Final Visit: Very Much Worse |
---|
Mirabegron 25 mg | 188 | 2 | 6 | 32 | 134 | 9 | 5 | 0 | 175 | 22 | 52 | 59 | 37 | 4 | 1 | 0 | 183 | 22 | 54 | 60 | 41 | 4 | 2 | 0 |
,Mirabegron 50 mg | 196 | 0 | 3 | 33 | 148 | 8 | 4 | 0 | 171 | 28 | 58 | 42 | 41 | 2 | 0 | 0 | 185 | 30 | 60 | 48 | 44 | 2 | 1 | 0 |
,Placebo | 182 | 0 | 6 | 31 | 126 | 13 | 3 | 3 | 158 | 13 | 48 | 53 | 32 | 6 | 5 | 1 | 171 | 13 | 49 | 58 | 38 | 6 | 6 | 1 |
[back to top]
Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale
The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Baseline: Total | Baseline: Very Much Improved | Baseline: Much Improved | Baseline: Minimally Improved | Baseline: No Change | Baseline: Minimally Worse | Baseline: Much Worse | Baseline: Very Much Worse | Week 12: Total | Week 12: Very Much Improved | Week 12: Much Improved | Week 12: Minimally Improved | Week 12: No Change | Week 12: Minimally Worse | Week 12: Much Worse | Final Visit: Total | Final Visit: Very Much Improved | Final Visit: Much Improved | Final Visit: Minimally Improved | Final Visit: No Change | Final Visit: Minimally Worse | Final Visit: Much Worse |
---|
Mirabegron 25 mg | 194 | 4 | 15 | 52 | 105 | 11 | 5 | 2 | 176 | 23 | 57 | 57 | 33 | 5 | 1 | 185 | 23 | 60 | 57 | 36 | 7 | 2 |
,Mirabegron 50 mg | 202 | 2 | 12 | 42 | 124 | 13 | 9 | 0 | 174 | 37 | 48 | 45 | 42 | 1 | 1 | 188 | 39 | 51 | 49 | 45 | 1 | 3 |
,Placebo | 188 | 4 | 14 | 48 | 105 | 6 | 5 | 6 | 160 | 18 | 54 | 49 | 26 | 5 | 8 | 173 | 18 | 54 | 52 | 35 | 6 | 8 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | Urgency episodes (Least Squares Mean) |
---|
| Week 4 [N=412; 409; 423] | Week 8 [N=377; 393; 398] | Week 12 [N=364; 385; 385] |
---|
Mirabegron 25 mg | -0.97 | -1.51 | -1.72 |
,Mirabegron 50 mg | -1.47 | -1.73 | -1.99 |
,Placebo | -0.90 | -1.17 | -1.60 |
[back to top]
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. (NCT00912964)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 4 [N=412; 409; 423] | Week 8 [N=377; 393; 398] | Week 12 [N=364; 385; 385] |
---|
Mirabegron 25 mg | -0.12 | -0.19 | -0.23 |
,Mirabegron 50 mg | -0.20 | -0.26 | -0.30 |
,Placebo | -0.10 | -0.15 | -0.19 |
[back to top]
Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale
The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| Baseline: Total | Baseline: Very Much Improved | Baseline: Much Improved | Baseline: Minimally Improved | Baseline: No Change | Baseline: Minimally Worse | Baseline: Much Worse | Baseline: Very Much Worse | Week 12: Total | Week 12: Very Much Improved | Week 12: Much Improved | Week 12: Minimally Improved | Week 12: No Change | Week 12: Minimally Worse | Week 12: Much Worse | Final Visit: Total | Final Visit: Very Much Improved | Final Visit: Much Improved | Final Visit: Minimally Improved | Final Visit: No Change | Final Visit: Minimally Worse | Final Visit: Much Worse |
---|
Mirabegron 25 mg | 194 | 5 | 12 | 47 | 115 | 12 | 1 | 2 | 176 | 19 | 60 | 54 | 39 | 3 | 1 | 185 | 19 | 62 | 54 | 43 | 5 | 2 |
,Mirabegron 50 mg | 202 | 2 | 11 | 41 | 132 | 11 | 5 | 0 | 174 | 36 | 51 | 47 | 38 | 2 | 0 | 188 | 38 | 54 | 49 | 43 | 3 | 1 |
,Placebo | 188 | 3 | 13 | 46 | 112 | 6 | 3 | 5 | 160 | 19 | 47 | 50 | 33 | 4 | 7 | 173 | 19 | 47 | 53 | 42 | 4 | 8 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percent work time missed (Mean) |
---|
| Week 12 [N=112; 118; 118] | Final Visit (LOCF) [N=119; 122; 123] |
---|
Mirabegron 25 mg | 0.7 | 0.7 |
,Mirabegron 50 mg | -1.5 | -1.3 |
,Placebo | 0.6 | 0.6 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percent overall work impairment (Mean) |
---|
| Week 12 [N=110; 115; 118] | Final Visit (LOCF) [N=117; 119; 123] |
---|
Mirabegron 25 mg | -11.0 | -10.8 |
,Mirabegron 50 mg | -13.3 | -13.3 |
,Placebo | -14.1 | -13.8 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percent impairment while working (Mean) |
---|
| Week 12 [N=123; 130; 128] | Final Visit (LOCF) [N=130; 135; 134] |
---|
Mirabegron 25 mg | -10.2 | -10.1 |
,Mirabegron 50 mg | -13.0 | -13.1 |
,Placebo | -11.6 | -11.5 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | percent activity impairment (Mean) |
---|
| Week 12 [N=353; 366; 362] | Final Visit (LOCF) [N=373; 376; 378] |
---|
Mirabegron 25 mg | -12.3 | -11.9 |
,Mirabegron 50 mg | -13.1 | -13.3 |
,Placebo | -11.4 | -11.0 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=357; 379; 371] | Final Visit (LOCF) [N=377; 389; 388] |
---|
Mirabegron 25 mg | 1.58 | 1.54 |
,Mirabegron 50 mg | 1.94 | 1.88 |
,Placebo | 1.18 | 1.05 |
[back to top]
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | scores on a scale (Least Squares Mean) |
---|
| Week 12 [N=357; 381; 378] | Final Visit (LOCF) [N=376; 391; 395] |
---|
Mirabegron 25 mg | -0.8 | -0.8 |
,Mirabegron 50 mg | -0.8 | -0.7 |
,Placebo | -0.7 | -0.7 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to perform usual activities | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems->Unable to perform usual activities | Some problems -> Missing data | Unable to perform usual activities -> No problems | Unable to perform usual activities-> Some problems | Unable to perform -> Unable to perform | Unable to perform usual activities -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to perform usual activities | Missing data -> Missing data |
---|
Mirabegron 25 mg | 303 | 27 | 1 | 0 | 38 | 35 | 1 | 0 | 0 | 1 | 0 | 1 | 2 | 1 | 0 | 0 |
,Mirabegron 50 mg | 293 | 31 | 0 | 4 | 51 | 44 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 313 | 27 | 0 | 6 | 35 | 30 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem -> No problem | No problem -> Some problems | No problem -> Unable to wash or dress myself | No problem -> Missing data | Some problems -> No problems | Some problems -> Some problems | Some problems -> Unable to wash or dress myself | Some problems -> Missing data | Unable to wash or dress myself -> No problems | Unable to wash or dress myself -> Some problems | Unable to wash or dress -> Unable to wash or dress | Unable to wash or dress myself -> Missing data | Missing data -> No problem | Missing data -> Some problems | Missing data -> Unable to wash or dress myself | Missing data -> Missing data |
---|
Mirabegron 25 mg | 385 | 10 | 0 | 1 | 3 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
,Mirabegron 50 mg | 403 | 6 | 1 | 4 | 2 | 9 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 389 | 5 | 0 | 7 | 5 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit." (NCT00912964)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain -> No pain | No pain -> Moderate pain | No pain -> Extreme pain | No pain -> Missing data | Moderate pain -> No pain | Moderate pain -> Moderate pain | Moderate pain -> Extreme pain | Moderate pain ->Missing data | Extreme pain -> No pain | Extreme pain -> Moderate pain | Extreme pain -> Extreme pain | Extreme pain -> Missing data | Missing data-> No pain | Missing data -> Moderate pain | Missing data -> Extreme pain | Missing data -> Missing data |
---|
Mirabegron 25 mg | 200 | 36 | 4 | 0 | 65 | 92 | 0 | 0 | 0 | 4 | 5 | 1 | 1 | 2 | 0 | 0 |
,Mirabegron 50 mg | 185 | 41 | 3 | 3 | 75 | 87 | 7 | 0 | 5 | 13 | 5 | 1 | 1 | 0 | 0 | 0 |
,Placebo | 209 | 34 | 2 | 4 | 58 | 85 | 5 | 3 | 0 | 9 | 2 | 0 | 2 | 2 | 0 | 0 |
[back to top]
[back to top]
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 2.44 |
Mirabegron 25 mg | 2.61 |
Mirabegron 50 mg | 3.17 |
Solifenacin 2.5 mg | 3.10 |
Solifenacin 5 mg | 2.78 |
Solifenacin 10 mg | 2.96 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 2.96 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 3.24 |
Solifenacin 5 mg + Mirabegron 25 mg | 3.47 |
Solifenacin 5 mg + Mirabegron 50 mg | 3.24 |
Solifenacin 10 mg + Mirabegron 25 mg | 3.51 |
Solifenacin 10 mg + Mirabegron 50 mg | 3.72 |
[back to top]
[back to top]
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
Placebo | 13.1 |
Mirabegron 25 mg | 5.8 |
Mirabegron 50 mg | 14.3 |
Solifenacin 2.5 mg | 11.1 |
Solifenacin 5 mg | 11.9 |
Solifenacin 10 mg | 13.3 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 11.6 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 12.5 |
Solifenacin 5 mg + Mirabegron 25 mg | 11.8 |
Solifenacin 5 mg + Mirabegron 50 mg | 15.9 |
Solifenacin 10 mg + Mirabegron 25 mg | 15.3 |
Solifenacin 10 mg + Mirabegron 50 mg | 11.1 |
[back to top]
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | mL (Least Squares Mean) |
---|
Placebo | 14.0 |
Mirabegron 25 mg | 24.9 |
Mirabegron 50 mg | 34.5 |
Solifenacin 2.5 mg | 36.4 |
Solifenacin 5 mg | 36.0 |
Solifenacin 10 mg | 36.2 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 39.4 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 41.9 |
Solifenacin 5 mg + Mirabegron 25 mg | 53.6 |
Solifenacin 5 mg + Mirabegron 50 mg | 54.2 |
Solifenacin 10 mg + Mirabegron 25 mg | 57.6 |
Solifenacin 10 mg + Mirabegron 50 mg | 62.3 |
[back to top]
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -1.4 |
Mirabegron 25 mg | -1.4 |
Mirabegron 50 mg | -1.5 |
Solifenacin 2.5 mg | -1.5 |
Solifenacin 5 mg | -1.3 |
Solifenacin 10 mg | -1.5 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -1.4 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -1.7 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.7 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.8 |
Solifenacin 10 mg + Mirabegron 25 mg | -1.8 |
Solifenacin 10 mg + Mirabegron 50 mg | -1.6 |
[back to top]
Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 6.4 |
Mirabegron 25 mg | 4.1 |
Mirabegron 50 mg | 5.3 |
Solifenacin 2.5 mg | 4.0 |
Solifenacin 5 mg | 4.8 |
Solifenacin 10 mg | 2.7 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 4.3 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 2.8 |
Solifenacin 5 mg + Mirabegron 25 mg | 2.9 |
Solifenacin 5 mg + Mirabegron 50 mg | 1.4 |
Solifenacin 10 mg + Mirabegron 25 mg | 1.3 |
Solifenacin 10 mg + Mirabegron 50 mg | 6.4 |
[back to top]
Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 69.2 |
Mirabegron 25 mg | 76.7 |
Mirabegron 50 mg | 78.9 |
Solifenacin 2.5 mg | 68.0 |
Solifenacin 5 mg | 72.8 |
Solifenacin 10 mg | 84.9 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 74.5 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 83.2 |
Solifenacin 5 mg + Mirabegron 25 mg | 77.9 |
Solifenacin 5 mg + Mirabegron 50 mg | 82.6 |
Solifenacin 10 mg + Mirabegron 25 mg | 82.9 |
Solifenacin 10 mg + Mirabegron 50 mg | 75.6 |
[back to top]
Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 39.7 |
Mirabegron 25 mg | 42.5 |
Mirabegron 50 mg | 38.2 |
Solifenacin 2.5 mg | 44.0 |
Solifenacin 5 mg | 42.2 |
Solifenacin 10 mg | 46.6 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 48.2 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 52.4 |
Solifenacin 5 mg + Mirabegron 25 mg | 54.4 |
Solifenacin 5 mg + Mirabegron 50 mg | 54.9 |
Solifenacin 10 mg + Mirabegron 25 mg | 57.9 |
Solifenacin 10 mg + Mirabegron 50 mg | 50.0 |
[back to top]
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No anxiety → No anxiety | No anxiety → Moderate anxiety | No anxiety → Extreme anxiety | No anxiety → Missing data | Moderate anxiety → No anxiety | Moderate anxiety → Moderate anxiety | Moderate anxiety → Extreme anxiety | Moderate anxiety → Missing data | Extreme anxiety → No anxiety | Extreme anxiety → Moderate anxiety | Extreme anxiety → Extreme anxiety | Extreme anxiety → Missing data | Missing data → No anxiety | Missing data → Moderate anxiety | Missing data → Extreme anxiety | Missing data → Missing data |
---|
Mirabegron 25 mg | 38 | 8 | 0 | 0 | 9 | 18 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 39 | 7 | 0 | 0 | 15 | 14 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 41 | 5 | 1 | 0 | 17 | 13 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 36 | 6 | 0 | 0 | 19 | 12 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 44 | 5 | 0 | 0 | 15 | 8 | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 36 | 6 | 0 | 2 | 14 | 19 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 42 | 4 | 0 | 0 | 21 | 9 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 81 | 7 | 0 | 1 | 25 | 21 | 1 | 0 | 1 | 7 | 1 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 78 | 5 | 1 | 1 | 35 | 22 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
,Solifenacin 5 mg | 76 | 11 | 1 | 0 | 24 | 33 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 76 | 9 | 0 | 1 | 28 | 19 | 1 | 1 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 80 | 3 | 0 | 1 | 33 | 26 | 1 | 1 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Confined to bed | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Confined to bed | Some problems → Missing data | Confined → No problems | Confined → Some problems | Confined → Confined to bed | Confined → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Confined to bed | Missing data → Missing data |
---|
Mirabegron 25 mg | 58 | 1 | 0 | 1 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 63 | 4 | 0 | 1 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 60 | 6 | 0 | 1 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 54 | 4 | 0 | 1 | 8 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 59 | 0 | 0 | 0 | 11 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 56 | 5 | 0 | 2 | 8 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 59 | 4 | 0 | 0 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 94 | 9 | 0 | 1 | 21 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 113 | 5 | 0 | 1 | 15 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 118 | 6 | 0 | 0 | 11 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 102 | 9 | 0 | 1 | 13 | 15 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 120 | 1 | 0 | 1 | 14 | 11 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No pain → No pain | No pain → Moderate pain | No pain → Extreme pain | No pain → Missing data | Moderate pain → No pain | Moderate pain → Moderate pain | Moderate pain → Extreme pain | Moderate pain → Missing data | Extreme pain → No pain | Extreme pain → Moderate pain | Extreme pain → Extreme pain | Extreme pain → Missing data | Missing data → No pain | Missing data → Moderate pain | Missing data → Extreme pain | Missing data → Missing data |
---|
Mirabegron 25 mg | 33 | 12 | 0 | 0 | 14 | 15 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 40 | 6 | 0 | 0 | 10 | 19 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,Placebo | 38 | 9 | 0 | 0 | 12 | 16 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 35 | 3 | 1 | 1 | 13 | 18 | 0 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 39 | 8 | 0 | 0 | 14 | 12 | 1 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 32 | 6 | 0 | 2 | 20 | 18 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 38 | 4 | 0 | 0 | 12 | 19 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 67 | 6 | 1 | 1 | 24 | 37 | 4 | 0 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 61 | 11 | 0 | 1 | 34 | 33 | 1 | 0 | 1 | 2 | 2 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 70 | 15 | 0 | 0 | 24 | 37 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 66 | 14 | 0 | 0 | 28 | 27 | 0 | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 73 | 7 | 0 | 1 | 36 | 25 | 0 | 1 | 1 | 4 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Unable | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Unable | Some problems → Missing data | Unable → No problems | Unable → Some problems | Unable → Unable | Unable → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Unable | Missing data → Missing data |
---|
Mirabegron 25 mg | 69 | 1 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 73 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 76 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 68 | 2 | 1 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 74 | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 72 | 0 | 0 | 2 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 72 | 2 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 128 | 5 | 0 | 1 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 138 | 2 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 138 | 2 | 1 | 0 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 130 | 1 | 0 | 2 | 3 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 141 | 1 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category." (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problem → No problem | No problem → Some problems | No problem → Unable | No problem → Missing data | Some problems → No problems | Some problems → Some problems | Some problems → Unable | Some problems → Missing data | Unable → No problems | Unable → Some problems | Unable → Unable | Unable → Missing data | Missing data → No problem | Missing data → Some problems | Missing data → Unable | Missing data → Missing data |
---|
Mirabegron 25 mg | 52 | 2 | 0 | 0 | 11 | 10 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg | 58 | 3 | 0 | 1 | 8 | 6 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 62 | 2 | 0 | 0 | 11 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg | 57 | 4 | 1 | 1 | 7 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 25 mg | 57 | 1 | 0 | 0 | 14 | 4 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 10 mg + Mirabegron 50 mg | 48 | 5 | 1 | 2 | 14 | 8 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg | 60 | 2 | 0 | 0 | 11 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 89 | 8 | 0 | 1 | 29 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 110 | 3 | 0 | 1 | 24 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Solifenacin 5 mg | 115 | 3 | 0 | 0 | 16 | 13 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 106 | 9 | 0 | 1 | 12 | 11 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 109 | 4 | 0 | 2 | 21 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 |
---|
Mirabegron 25 mg | -0.19 | -0.28 | -0.30 | -0.35 | -0.33 |
,Mirabegron 50 mg | -0.15 | -0.26 | -0.36 | -0.44 | -0.41 |
,Placebo | -0.24 | -0.32 | -0.42 | -0.48 | -0.46 |
,Solifenacin 10 mg | -0.21 | -0.35 | -0.44 | -0.49 | -0.47 |
,Solifenacin 10 mg + Mirabegron 25 mg | -0.31 | -0.41 | -0.53 | -0.61 | -0.59 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.20 | -0.31 | -0.43 | -0.49 | -0.47 |
,Solifenacin 2.5 mg | -0.25 | -0.33 | -0.45 | -0.42 | -0.45 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.19 | -0.32 | -0.39 | -0.43 | -0.42 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.26 | -0.35 | -0.41 | -0.54 | -0.50 |
,Solifenacin 5 mg | -0.14 | -0.23 | -0.30 | -0.33 | -0.33 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.26 | -0.35 | -0.45 | -0.50 | -0.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.28 | -0.37 | -0.46 | -0.54 | -0.55 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 |
---|
Mirabegron 25 mg | -0.43 | -0.48 | -0.65 | -0.59 |
,Mirabegron 50 mg | -0.85 | -0.89 | -0.92 | -0.89 |
,Placebo | -0.83 | -0.87 | -0.82 | -0.93 |
,Solifenacin 10 mg | -0.71 | -0.84 | -1.04 | -0.95 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.14 | -1.18 | -0.93 | -0.27 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.77 | -0.71 | -0.91 | -0.96 |
,Solifenacin 2.5 mg | -0.98 | -1.20 | -1.12 | -1.21 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.49 | -0.73 | -0.78 | -0.74 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.64 | -0.67 | -0.82 | -0.88 |
,Solifenacin 5 mg | -0.67 | -0.80 | -0.72 | -0.84 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.70 | -0.81 | -1.01 | -1.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.65 | -0.88 | -0.95 | -1.11 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 |
---|
Mirabegron 25 mg | -1.69 | -2.02 | -2.27 | -2.51 |
,Mirabegron 50 mg | -1.60 | -1.99 | -2.42 | -2.67 |
,Placebo | -1.18 | -1.68 | -2.27 | -2.59 |
,Solifenacin 10 mg | -1.32 | -2.25 | -2.97 | -3.31 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.74 | -2.55 | -3.04 | -3.47 |
,Solifenacin 10 mg + Mirabegron 50 mg | -2.35 | -2.69 | -3.49 | -3.63 |
,Solifenacin 2.5 mg | -1.49 | -2.10 | -2.46 | -2.38 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -1.52 | -2.03 | -2.58 | -2.64 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -1.95 | -2.11 | -2.66 | -3.02 |
,Solifenacin 5 mg | -1.16 | -1.80 | -2.22 | -2.58 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.68 | -2.29 | -2.43 | -2.64 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.21 | -2.77 | -3.20 | -3.35 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 |
---|
Mirabegron 25 mg | -0.37 | -0.60 | -0.65 | -0.69 | -0.69 |
,Mirabegron 50 mg | -0.60 | -0.71 | -0.68 | -0.84 | -0.82 |
,Placebo | -0.33 | -0.50 | -0.64 | -0.79 | -0.74 |
,Solifenacin 10 mg | -0.45 | -0.74 | -1.01 | -0.99 | -0.95 |
,Solifenacin 10 mg + Mirabegron 25 mg | -0.43 | -0.67 | -0.81 | -0.98 | -0.94 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.53 | -0.75 | -0.91 | -1.03 | -0.96 |
,Solifenacin 2.5 mg | -0.38 | -0.55 | -0.80 | -0.59 | -0.68 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.43 | -0.59 | -0.76 | -0.75 | -0.73 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.51 | -0.54 | -0.79 | -0.81 | -0.77 |
,Solifenacin 5 mg | -0.30 | -0.47 | -0.65 | -0.70 | -0.69 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.49 | -0.69 | -0.76 | -0.80 | -0.77 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.61 | -0.80 | -0.98 | -1.05 | -1.04 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | pads (Least Squares Mean) |
---|
| Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 |
---|
Mirabegron 25 mg | -0.87 | -0.93 | -0.90 | -0.97 | -1.04 |
,Mirabegron 50 mg | -0.88 | -0.70 | -1.11 | -0.93 | -0.95 |
,Placebo | -0.81 | -0.76 | -0.97 | -0.92 | -0.63 |
,Solifenacin 10 mg | -0.91 | -1.23 | -1.53 | -1.75 | -1.73 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.13 | -1.35 | -1.37 | -1.60 | -1.59 |
,Solifenacin 10 mg + Mirabegron 50 mg | -1.31 | -1.36 | -1.56 | -1.60 | -1.63 |
,Solifenacin 2.5 mg | -1.31 | -1.62 | -1.47 | -1.35 | -1.44 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.86 | -0.94 | -1.10 | -1.02 | -1.04 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.96 | -1.09 | -1.39 | -1.44 | -1.38 |
,Solifenacin 5 mg | -0.92 | -1.26 | -1.25 | -1.39 | -1.38 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.89 | -1.24 | -1.29 | -1.45 | -1.46 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.02 | -1.30 | -1.51 | -1.63 | -1.63 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 |
---|
Mirabegron 25 mg | -2.06 | -2.70 | -2.86 | -3.31 | -3.23 |
,Mirabegron 50 mg | -1.91 | -2.70 | -3.27 | -3.65 | -3.44 |
,Placebo | -2.07 | -2.55 | -3.42 | -3.69 | -3.53 |
,Solifenacin 10 mg | -1.97 | -3.02 | -3.63 | -4.15 | -3.98 |
,Solifenacin 10 mg + Mirabegron 25 mg | -2.35 | -3.04 | -3.53 | -3.76 | -3.71 |
,Solifenacin 10 mg + Mirabegron 50 mg | -2.23 | -2.81 | -3.63 | -3.93 | -3.91 |
,Solifenacin 2.5 mg | -2.49 | -3.16 | -3.61 | -3.54 | -3.62 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -1.84 | -2.64 | -3.34 | -3.26 | -3.21 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -2.59 | -3.14 | -3.60 | -4.24 | -3.97 |
,Solifenacin 5 mg | -1.63 | -2.24 | -2.67 | -2.71 | -2.73 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.30 | -3.08 | -3.60 | -3.98 | -3.86 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.57 | -3.17 | -3.85 | -4.09 | -4.10 |
[back to top]
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 |
---|
Mirabegron 25 mg | -0.59 | -0.48 | -0.65 | -0.54 | -0.80 |
,Mirabegron 50 mg | -0.83 | -0.93 | -1.00 | -0.87 | -0.88 |
,Placebo | -0.80 | -0.83 | -0.86 | -0.84 | -0.86 |
,Solifenacin 10 mg | -0.77 | -1.00 | -1.16 | -1.13 | -1.13 |
,Solifenacin 10 mg + Mirabegron 25 mg | -1.12 | -1.20 | -0.91 | -0.28 | -0.28 |
,Solifenacin 10 mg + Mirabegron 50 mg | -0.76 | -0.68 | -0.88 | -0.93 | -0.94 |
,Solifenacin 2.5 mg | -0.96 | -1.13 | -1.04 | -1.13 | -1.17 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.52 | -0.73 | -0.86 | -0.81 | -0.81 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.68 | -0.70 | -0.84 | -0.91 | -0.87 |
,Solifenacin 5 mg | -0.66 | -0.77 | -0.76 | -0.83 | -0.86 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.68 | -0.81 | -0.99 | -1.19 | -1.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.64 | -0.86 | -0.89 | -1.06 | -1.08 |
[back to top]
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 |
---|
Mirabegron 25 mg | 14.3 | 16.8 | 24.6 | 23.0 |
,Mirabegron 50 mg | 26.0 | 29.4 | 35.4 | 35.5 |
,Placebo | 8.7 | 10.2 | 13.5 | 14.7 |
,Solifenacin 10 mg | 16.1 | 28.3 | 37.7 | 35.8 |
,Solifenacin 10 mg + Mirabegron 25 mg | 29.5 | 45.7 | 55.8 | 59.8 |
,Solifenacin 10 mg + Mirabegron 50 mg | 42.1 | 54.5 | 68.5 | 66.2 |
,Solifenacin 2.5 mg | 22.7 | 24.8 | 28.3 | 36.9 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 22.5 | 29.2 | 35.6 | 38.6 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 29.2 | 36.5 | 42.3 | 43.7 |
,Solifenacin 5 mg | 23.1 | 29.6 | 30.1 | 34.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 29.9 | 42.7 | 49.7 | 54.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 32.3 | 44.5 | 52.2 | 56.6 |
[back to top]
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Mean) |
---|
| Percent work time missed | Percent impairment while working | Percent overall work impairment | Percent activity impairment |
---|
Mirabegron 25 mg | 0.53 | -16.13 | -16.32 | -14.52 |
,Mirabegron 50 mg | -0.24 | -10.00 | -9.91 | -13.95 |
,Placebo | -2.44 | -7.50 | -9.50 | -9.62 |
,Solifenacin 10 mg | -0.28 | -10.00 | -9.95 | -17.12 |
,Solifenacin 10 mg + Mirabegron 25 mg | 0.79 | -18.00 | -17.69 | -19.34 |
,Solifenacin 10 mg + Mirabegron 50 mg | -1.12 | -9.29 | -10.32 | -19.74 |
,Solifenacin 2.5 mg | -2.85 | -16.67 | -17.88 | -13.73 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | -0.55 | -8.43 | -8.59 | -14.11 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.83 | -17.72 | -17.16 | -25.31 |
,Solifenacin 5 mg | -1.29 | -17.33 | -17.26 | -14.38 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.84 | -13.85 | -14.00 | -17.43 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.65 | -13.39 | -14.18 | -20.42 |
[back to top]
Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 |
---|
Mirabegron 25 mg | 30.8 | 40.0 | 60.0 | 70.0 | 61.5 |
,Mirabegron 50 mg | 66.7 | 72.2 | 77.8 | 77.8 | 77.8 |
,Placebo | 64.7 | 82.4 | 76.5 | 94.1 | 94.1 |
,Solifenacin 10 mg | 57.1 | 78.6 | 86.7 | 64.3 | 66.7 |
,Solifenacin 10 mg + Mirabegron 25 mg | 91.7 | 95.8 | 91.7 | 95.8 | 95.8 |
,Solifenacin 10 mg + Mirabegron 50 mg | 68.4 | 68.4 | 75.0 | 90.0 | 90.0 |
,Solifenacin 2.5 mg | 73.3 | 86.7 | 85.7 | 84.6 | 86.7 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 51.4 | 64.7 | 82.9 | 66.7 | 68.6 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 66.7 | 63.3 | 73.3 | 80.0 | 75.8 |
,Solifenacin 5 mg | 57.6 | 76.5 | 58.8 | 73.5 | 74.3 |
,Solifenacin 5 mg + Mirabegron 25 mg | 71.9 | 75.0 | 90.6 | 96.7 | 96.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 66.7 | 78.3 | 81.8 | 95.7 | 95.8 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant. (NCT01340027)
Timeframe: Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 |
---|
Mirabegron 25 mg | 23.1 | 20.0 | 50.0 | 50.0 | 46.2 |
,Mirabegron 50 mg | 44.4 | 55.6 | 61.1 | 61.1 | 61.1 |
,Placebo | 47.1 | 64.7 | 58.8 | 82.4 | 82.4 |
,Solifenacin 10 mg | 50.0 | 71.4 | 73.3 | 57.1 | 53.3 |
,Solifenacin 10 mg + Mirabegron 25 mg | 70.8 | 79.2 | 79.2 | 79.2 | 79.2 |
,Solifenacin 10 mg + Mirabegron 50 mg | 52.6 | 52.6 | 65.0 | 75.0 | 75.0 |
,Solifenacin 2.5 mg | 40.0 | 73.3 | 71.4 | 69.2 | 66.7 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 40.0 | 55.9 | 54.3 | 51.5 | 54.3 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 51.5 | 46.7 | 50.0 | 63.3 | 60.6 |
,Solifenacin 5 mg | 45.5 | 64.7 | 50.0 | 58.8 | 60.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 65.6 | 62.5 | 71.9 | 86.7 | 87.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.4 | 52.2 | 77.3 | 87.0 | 87.5 |
[back to top]
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | percentage of participants (Number) |
---|
Placebo | 73.4 |
Mirabegron 25 mg | 84.0 |
Mirabegron 50 mg | 78.9 |
Solifenacin 2.5 mg | 85.7 |
Solifenacin 5 mg | 81.3 |
Solifenacin 10 mg | 85.3 |
Solifenacin 2.5 mg + Mirabegron 25 mg | 82.6 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 85.5 |
Solifenacin 5 mg + Mirabegron 25 mg | 85.6 |
Solifenacin 5 mg + Mirabegron 50 mg | 88.4 |
Solifenacin 10 mg + Mirabegron 25 mg | 88.5 |
Solifenacin 10 mg + Mirabegron 50 mg | 83.3 |
[back to top]
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -25.5 |
Mirabegron 25 mg | -27.1 |
Mirabegron 50 mg | -27.5 |
Solifenacin 2.5 mg | -29.8 |
Solifenacin 5 mg | -26.8 |
Solifenacin 10 mg | -29.9 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -28.0 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -31.7 |
Solifenacin 5 mg + Mirabegron 25 mg | -32.0 |
Solifenacin 5 mg + Mirabegron 50 mg | -33.5 |
Solifenacin 10 mg + Mirabegron 25 mg | -33.6 |
Solifenacin 10 mg + Mirabegron 50 mg | -31.4 |
[back to top]
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline. (NCT01340027)
Timeframe: Baseline and Weeks 2, 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 |
---|
Mirabegron 25 mg | 25.7 | 27.8 | 35.7 | 46.4 | 42.7 |
,Mirabegron 50 mg | 37.3 | 43.8 | 50.7 | 47.2 | 47.4 |
,Placebo | 27.8 | 42.3 | 53.9 | 55.4 | 53.2 |
,Solifenacin 10 mg | 34.7 | 44.4 | 56.2 | 55.6 | 54.7 |
,Solifenacin 10 mg + Mirabegron 25 mg | 36.4 | 48.1 | 57.1 | 65.3 | 65.4 |
,Solifenacin 10 mg + Mirabegron 50 mg | 46.1 | 41.9 | 64.4 | 61.1 | 58.2 |
,Solifenacin 2.5 mg | 29.6 | 35.6 | 43.1 | 53.6 | 54.8 |
,Solifenacin 2.5 mg + Mirabegron 25 mg | 36.4 | 45.3 | 46.8 | 55.1 | 54.2 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 38.5 | 42.1 | 54.3 | 55.1 | 53.1 |
,Solifenacin 5 mg | 26.4 | 34.0 | 40.0 | 47.9 | 47.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 34.1 | 48.2 | 49.6 | 53.8 | 52.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 36.5 | 56.4 | 56.3 | 62.0 | 61.6 |
[back to top]
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -2.43 |
Mirabegron 25 mg | -2.48 |
Mirabegron 50 mg | -2.56 |
Solifenacin 2.5 mg | -2.44 |
Solifenacin 5 mg | -2.54 |
Solifenacin 10 mg | -3.22 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -2.58 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -2.93 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.56 |
Solifenacin 5 mg + Mirabegron 50 mg | -3.34 |
Solifenacin 10 mg + Mirabegron 25 mg | -3.42 |
Solifenacin 10 mg + Mirabegron 50 mg | -3.52 |
[back to top]
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. (NCT01340027)
Timeframe: Baseline and Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo | -0.95 |
Mirabegron 25 mg | -0.74 |
Mirabegron 50 mg | -0.90 |
Solifenacin 2.5 mg | -1.26 |
Solifenacin 5 mg | -0.88 |
Solifenacin 10 mg | -0.97 |
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.75 |
Solifenacin 2.5 mg + Mirabegron 50 mg | -0.85 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.22 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.14 |
Solifenacin 10 mg + Mirabegron 25 mg | -0.27 |
Solifenacin 10 mg + Mirabegron 50 mg | -0.97 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 47.3 | 64.3 | 69.0 | 67.3 |
,Solifenacin 5 mg | 52.0 | 63.2 | 69.5 | 68.5 |
[back to top]
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] | Final visit [N=920,910] |
---|
Mirabegron 50 mg | 32.3 | 41.2 | 44.8 | 44.2 |
,Solifenacin 5 mg | 33.9 | 46.9 | 49.3 | 48.8 |
[back to top]
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥2 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 47.6 | 46.2 |
,Solifenacin 5 mg | 52.6 | 51.1 |
[back to top]
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| ≥1 point improvement | ≥2 point improvement | ≥3 point improvement | ≥4 point improvement | ≥5 point improvement | 6 point improvement |
---|
Mirabegron 50 mg | 86.4 | 80.3 | 67.7 | 44.4 | 15.6 | 2.5 |
,Solifenacin 5 mg | 90.4 | 83.6 | 71.9 | 47.5 | 15.4 | 2.9 |
[back to top]
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale. (NCT01638000)
Timeframe: Baseline to final visit (up to Week 12)
Intervention | percentage of participants (Number) |
---|
| ≥1 point improvement | ≥2 point improvement | ≥3 point improvement | ≥4 point improvement | ≥5 point improvement | 6 point improvement |
---|
Mirabegron 50 mg | 85.6 | 79.0 | 66.7 | 43.8 | 15.4 | 2.5 |
,Solifenacin 5 mg | 89.4 | 82.6 | 70.8 | 46.6 | 15.1 | 2.8 |
[back to top]
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 77.5 | 76.2 |
,Solifenacin 5 mg | 82.4 | 81.2 |
[back to top]
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
A responder is defined as a participant with ≥1 point improvement in PPBC from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 73.1 | 71.9 |
,Solifenacin 5 mg | 76.7 | 74.9 |
[back to top]
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline. (NCT01638000)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | 69.2 | 67.5 |
,Solifenacin 5 mg | 72.6 | 71.0 |
[back to top]
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | percentage of participants (Number) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 75.5 | 85.5 | 86.1 | 85.1 |
,Solifenacin 5 mg | 77.3 | 86.9 | 89.1 | 88.1 |
[back to top]
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). (NCT01638000)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Intervention | percentage of participants (Number) |
---|
| Overall | Dry mouth | Dry throat | Blurred vision | Constipation |
---|
Mirabegron 50 mg | 5 | 3.1 | 0.1 | 0.6 | 2.2 |
,Solifenacin 5 mg | 7.4 | 5.8 | 0.1 | 0.4 | 2.5 |
[back to top]
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | pads (Mean) |
---|
| Week 4 [N=574,563] | Week 8 [N=551,543] | Week 12 [N=543,532] | Final visit [N=576,565] |
---|
Mirabegron 50 mg | 4.25 | 3.33 | 3.19 | 3.32 |
,Solifenacin 5 mg | 4.26 | 3.27 | 3.04 | 3.19 |
[back to top]
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | nocturia episodes (Mean) |
---|
| Week 4 [N=877,871] | Week 8 [N=850, 844] | Week 12 [N=831,828] | Final Visit [N=879,875] |
---|
Mirabegron 50 mg | 4.78 | 4.26 | 3.94 | 4.05 |
,Solifenacin 5 mg | 5.12 | 4.41 | 4.06 | 4.13 |
[back to top]
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | incontinence episodes (Mean) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] | Final visit [N=404,413] |
---|
Mirabegron 50 mg | 2.64 | 2.19 | 2.07 | 2.13 |
,Solifenacin 5 mg | 2.25 | 1.28 | 1.08 | 1.29 |
[back to top]
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=905,896] | Week 8 [N=882,875] | Week 12 [N=865,859] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | -20.51 | -25.96 | -29.74 | -28.89 |
,Solifenacin 5 mg | -22.20 | -27.76 | -31.84 | -30.76 |
[back to top]
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=905,896] | Week 8 [N=882,875] | Week 12 [N=865,858] | Final visit [N=906,897] |
---|
Mirabegron 50 mg | -0.91 | -1.30 | -1.58 | -1.53 |
,Solifenacin 5 mg | -1.00 | -1.46 | -1.73 | -1.67 |
[back to top]
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 430 | 48 | 15 | 2 | 0 | 16 | 101 | 45 | 16 | 3 | 1 | 3 | 61 | 57 | 26 | 10 | 1 | 6 | 13 | 23 | 12 | 7 | 0 | 2 | 5 | 2 | 2 | 2 | 0 | 1 | 3 | 5 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 426 | 49 | 11 | 3 | 0 | 13 | 109 | 50 | 12 | 2 | 0 | 4 | 53 | 53 | 20 | 6 | 1 | 6 | 16 | 32 | 15 | 3 | 0 | 5 | 4 | 5 | 3 | 0 | 2 | 0 | 4 | 1 | 0 | 0 | 0 | 4 |
[back to top]
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> exteme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 672 | 35 | 7 | 1 | 1 | 20 | 42 | 19 | 9 | 1 | 0 | 3 | 34 | 17 | 5 | 2 | 0 | 2 | 17 | 9 | 4 | 2 | 0 | 1 | 1 | 4 | 0 | 0 | 0 | 2 | 6 | 2 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 673 | 38 | 2 | 1 | 1 | 21 | 33 | 20 | 9 | 0 | 0 | 2 | 34 | 16 | 6 | 2 | 0 | 2 | 13 | 15 | 8 | 0 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 1 | 5 | 0 | 0 | 0 | 0 | 4 |
[back to top]
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 291 | 52 | 13 | 4 | 1 | 10 | 103 | 111 | 25 | 6 | 0 | 7 | 59 | 66 | 46 | 10 | 1 | 8 | 17 | 37 | 12 | 18 | 2 | 2 | 1 | 4 | 2 | 0 | 1 | 1 | 4 | 4 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 286 | 66 | 16 | 0 | 0 | 10 | 96 | 103 | 30 | 1 | 0 | 5 | 61 | 78 | 57 | 4 | 1 | 8 | 16 | 25 | 15 | 7 | 1 | 4 | 3 | 4 | 4 | 1 | 0 | 1 | 2 | 3 | 0 | 0 | 0 | 4 |
[back to top]
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> modrate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 445 | 38 | 20 | 3 | 1 | 14 | 70 | 46 | 19 | 3 | 0 | 6 | 51 | 41 | 31 | 8 | 1 | 4 | 30 | 30 | 21 | 20 | 1 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 4 | 3 | 1 | 0 | 0 | 3 |
,Solifenacin 5 mg | 446 | 31 | 23 | 3 | 1 | 11 | 78 | 44 | 12 | 3 | 0 | 6 | 47 | 52 | 40 | 6 | 0 | 4 | 22 | 41 | 15 | 8 | 0 | 7 | 0 | 1 | 0 | 1 | 1 | 0 | 4 | 1 | 0 | 0 | 0 | 4 |
[back to top]
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 8
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 325 | 52 | 15 | 2 | 0 | 10 | 122 | 94 | 26 | 4 | 3 | 6 | 42 | 50 | 31 | 11 | 0 | 7 | 23 | 39 | 11 | 7 | 1 | 4 | 9 | 7 | 2 | 3 | 3 | 1 | 5 | 3 | 0 | 0 | 0 | 3 |
,Solifenacin 5 mg | 334 | 65 | 8 | 1 | 0 | 13 | 116 | 79 | 20 | 3 | 2 | 4 | 49 | 59 | 34 | 4 | 0 | 5 | 13 | 37 | 12 | 6 | 3 | 6 | 11 | 10 | 4 | 1 | 4 | 0 | 2 | 2 | 1 | 0 | 0 | 4 |
[back to top]
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 421 | 61 | 20 | 4 | 1 | 4 | 102 | 49 | 14 | 2 | 1 | 1 | 47 | 59 | 45 | 9 | 1 | 0 | 17 | 21 | 11 | 7 | 1 | 0 | 0 | 3 | 5 | 3 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 422 | 63 | 10 | 3 | 0 | 4 | 101 | 58 | 16 | 1 | 1 | 0 | 34 | 59 | 39 | 7 | 0 | 0 | 28 | 19 | 13 | 7 | 1 | 3 | 4 | 5 | 3 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 7 |
[back to top]
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> No problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 693 | 26 | 12 | 0 | 0 | 5 | 37 | 28 | 8 | 1 | 0 | 0 | 24 | 18 | 17 | 1 | 0 | 0 | 9 | 13 | 7 | 4 | 0 | 0 | 4 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 703 | 23 | 4 | 0 | 1 | 5 | 41 | 16 | 5 | 2 | 0 | 0 | 17 | 28 | 15 | 0 | 0 | 0 | 15 | 15 | 6 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 7 |
[back to top]
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extrme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 299 | 57 | 11 | 1 | 1 | 2 | 101 | 116 | 32 | 2 | 0 | 1 | 51 | 60 | 66 | 10 | 1 | 2 | 21 | 22 | 19 | 20 | 6 | 0 | 1 | 2 | 3 | 1 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 8 |
,Solifenacin 5 mg | 285 | 67 | 17 | 5 | 0 | 4 | 97 | 109 | 25 | 4 | 0 | 0 | 44 | 86 | 65 | 12 | 1 | 1 | 19 | 25 | 17 | 6 | 0 | 1 | 1 | 6 | 3 | 2 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 7 |
[back to top]
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 442 | 36 | 10 | 6 | 1 | 26 | 77 | 43 | 15 | 2 | 0 | 7 | 57 | 31 | 35 | 7 | 0 | 6 | 53 | 15 | 15 | 18 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 1 | 2 | 5 | 3 | 0 | 0 | 1 |
,Solifenacin 5 mg | 459 | 25 | 10 | 5 | 0 | 16 | 82 | 32 | 16 | 2 | 0 | 11 | 63 | 43 | 30 | 4 | 0 | 9 | 51 | 17 | 7 | 8 | 0 | 10 | 1 | 1 | 0 | 0 | 1 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 287 | 50 | 15 | 2 | 0 | 17 | 112 | 97 | 29 | 2 | 0 | 12 | 79 | 49 | 42 | 10 | 0 | 10 | 39 | 14 | 16 | 12 | 2 | 5 | 4 | 2 | 1 | 1 | 0 | 1 | 7 | 2 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg | 299 | 49 | 11 | 4 | 0 | 15 | 116 | 87 | 18 | 4 | 0 | 10 | 80 | 71 | 38 | 6 | 1 | 13 | 34 | 13 | 12 | 1 | 1 | 7 | 5 | 2 | 3 | 1 | 1 | 1 | 5 | 4 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 667 | 26 | 5 | 1 | 1 | 36 | 43 | 13 | 14 | 1 | 0 | 3 | 44 | 8 | 5 | 1 | 0 | 2 | 25 | 4 | 0 | 3 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 3 | 8 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 670 | 23 | 6 | 1 | 0 | 36 | 42 | 12 | 5 | 1 | 0 | 4 | 46 | 6 | 6 | 0 | 0 | 2 | 25 | 7 | 2 | 1 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 1 | 9 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 323 | 53 | 10 | 1 | 1 | 16 | 132 | 84 | 26 | 3 | 0 | 10 | 52 | 51 | 18 | 8 | 2 | 10 | 38 | 25 | 7 | 9 | 1 | 5 | 10 | 5 | 3 | 2 | 1 | 4 | 9 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 341 | 48 | 10 | 2 | 0 | 20 | 118 | 80 | 15 | 2 | 0 | 9 | 67 | 44 | 28 | 5 | 1 | 6 | 35 | 17 | 14 | 2 | 0 | 9 | 15 | 2 | 7 | 2 | 2 | 2 | 7 | 2 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 328 | 59 | 11 | 2 | 0 | 4 | 98 | 122 | 29 | 5 | 1 | 0 | 25 | 64 | 37 | 12 | 3 | 0 | 12 | 32 | 26 | 12 | 2 | 1 | 7 | 8 | 3 | 4 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 8 |
,Solifenacin 5 mg | 339 | 65 | 11 | 2 | 2 | 2 | 102 | 94 | 25 | 3 | 0 | 0 | 33 | 65 | 40 | 10 | 1 | 2 | 17 | 29 | 19 | 9 | 0 | 3 | 12 | 4 | 5 | 4 | 5 | 0 | 1 | 1 | 0 | 0 | 0 | 7 |
[back to top]
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 4
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> Slight problems | No problems -> Moderate problems | No problems -> Severe problems | No problems -> Extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 447 | 45 | 23 | 2 | 0 | 4 | 66 | 47 | 24 | 6 | 0 | 1 | 39 | 39 | 50 | 7 | 1 | 0 | 20 | 24 | 45 | 16 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
,Solifenacin 5 mg | 443 | 43 | 19 | 6 | 1 | 3 | 80 | 47 | 11 | 3 | 1 | 1 | 51 | 45 | 46 | 6 | 0 | 1 | 16 | 34 | 29 | 12 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 7 |
[back to top]
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 425 | 43 | 14 | 2 | 0 | 27 | 103 | 45 | 12 | 3 | 0 | 6 | 81 | 41 | 25 | 6 | 0 | 8 | 31 | 7 | 6 | 9 | 1 | 3 | 7 | 1 | 2 | 1 | 0 | 1 | 7 | 3 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 426 | 45 | 7 | 2 | 0 | 22 | 107 | 53 | 9 | 1 | 0 | 7 | 79 | 31 | 15 | 5 | 0 | 9 | 40 | 13 | 6 | 5 | 0 | 7 | 7 | 2 | 3 | 1 | 0 | 1 | 8 | 1 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -2.95 |
Solifenacin 5 mg | -3.13 |
[back to top]
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 [N=877,871] | Week 8 [N=850,844] | Week 12 [N=831,828] |
---|
Mirabegron 50 mg | -0.72 | -0.90 | -0.98 |
,Solifenacin 5 mg | -0.63 | -0.87 | -0.97 |
[back to top]
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8 , Week 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 [M=574,563] | Week 8 [N=551,543] | Week 12 [N=543,532] |
---|
Mirabegron 50 mg | -1.80 | -2.10 | -2.14 |
,Solifenacin 5 mg | -1.82 | -2.14 | -2.20 |
[back to top]
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] | Final visit [N=920,910] |
---|
Mirabegron 50 mg | -0.36 | -0.50 | -0.60 | -0.58 |
,Solifenacin 5 mg | -0.36 | -0.52 | -0.60 | -0.57 |
[back to top]
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 [N=915,905] | Week 8 [N=887,875] | Week 12 [N=869,855] | Final Visit [N=919,909] |
---|
Mirabegron 50 mg | -3.75 | -4.44 | -4.67 | -4.61 |
,Solifenacin 5 mg | -3.88 | -4.79 | -4.99 | -4.84 |
[back to top]
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=404,410] | Week 8 [N=387,397] | Week 12 [N=381,387] |
---|
Mirabegron 50 mg | -1.22 | -1.37 | -1.41 |
,Solifenacin 5 mg | -1.30 | -1.59 | -1.66 |
[back to top]
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
(NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 [N=916,906] | Week 8 [N=888,876] | Week 12 [N=870,856] |
---|
Mirabegron 50 mg | -2.37 | -2.77 | -3.02 |
,Solifenacin 5 mg | -2.33 | -3.00 | -3.21 |
[back to top]
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. (NCT01638000)
Timeframe: Week 4, Week 8, Week 12
Intervention | urgency incontinence episodes (Mean) |
---|
| Week 4 [N=395,399] | Week 8 [N=379,386] | Week 12 [N=373,377] | Final visit [N=395,402] |
---|
Mirabegron 50 mg | 2.27 | 1.74 | 1.44 | 1.51 |
,Solifenacin 5 mg | 2.16 | 1.13 | 1.03 | 1.23 |
[back to top]
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. (NCT01638000)
Timeframe: Baseline and Week 4, Week 8, Week 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 [N=395,399] | Week 8 [N=379,386] | Week 12 [N=373,377] |
---|
Mirabegron 50 mg | -1.22 | -1.39 | -1.49 |
,Solifenacin 5 mg | -1.24 | -1.56 | -1.59 |
[back to top]
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 332 | 55 | 11 | 2 | 1 | 3 | 133 | 92 | 26 | 4 | 0 | 0 | 55 | 52 | 22 | 10 | 2 | 0 | 38 | 25 | 8 | 12 | 1 | 1 | 10 | 6 | 3 | 3 | 3 | 0 | 9 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 356 | 52 | 10 | 2 | 0 | 1 | 121 | 83 | 17 | 2 | 1 | 0 | 68 | 45 | 29 | 6 | 1 | 2 | 35 | 18 | 15 | 6 | 0 | 3 | 15 | 2 | 7 | 3 | 3 | 0 | 7 | 2 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 460 | 37 | 14 | 6 | 1 | 3 | 80 | 45 | 16 | 2 | 0 | 1 | 60 | 33 | 36 | 7 | 0 | 0 | 53 | 15 | 17 | 20 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 5 | 3 | 0 | 0 | 1 |
,Solifenacin 5 mg | 471 | 25 | 12 | 5 | 0 | 2 | 88 | 34 | 18 | 2 | 0 | 1 | 67 | 46 | 31 | 4 | 0 | 1 | 52 | 17 | 11 | 11 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 297 | 55 | 15 | 2 | 0 | 2 | 116 | 103 | 30 | 2 | 0 | 1 | 80 | 51 | 48 | 10 | 0 | 1 | 39 | 16 | 16 | 15 | 2 | 0 | 4 | 2 | 1 | 1 | 1 | 0 | 7 | 2 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg | 306 | 52 | 13 | 4 | 0 | 3 | 118 | 93 | 20 | 4 | 0 | 0 | 83 | 72 | 44 | 7 | 2 | 1 | 34 | 14 | 15 | 3 | 1 | 1 | 5 | 2 | 3 | 1 | 1 | 1 | 5 | 4 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme data | No data -> no data |
---|
Mirabegron 50 mg | 697 | 27 | 5 | 1 | 2 | 4 | 43 | 15 | 15 | 1 | 0 | 0 | 45 | 8 | 6 | 1 | 0 | 0 | 25 | 4 | 0 | 4 | 0 | 0 | 5 | 1 | 0 | 0 | 1 | 0 | 8 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 699 | 26 | 6 | 1 | 0 | 4 | 43 | 14 | 6 | 1 | 0 | 0 | 46 | 6 | 8 | 0 | 0 | 0 | 25 | 7 | 4 | 1 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 1 | 9 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). (NCT01638000)
Timeframe: Baseline and final visit (up to Week 12)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problem | Extreme problems -> moderate problem | Extreme problems -> severe problem | Extreme problems -> extreme problem | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Mirabegron 50 mg | 444 | 46 | 15 | 2 | 0 | 4 | 106 | 45 | 15 | 3 | 0 | 0 | 83 | 42 | 29 | 7 | 0 | 0 | 31 | 9 | 6 | 10 | 1 | 0 | 7 | 1 | 2 | 1 | 1 | 0 | 7 | 3 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 440 | 49 | 8 | 2 | 0 | 3 | 113 | 54 | 9 | 1 | 0 | 0 | 79 | 34 | 20 | 6 | 0 | 0 | 41 | 14 | 8 | 5 | 0 | 3 | 7 | 2 | 3 | 1 | 1 | 0 | 8 | 1 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)." (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 [N=865,857] | Final visit [N=891,876] |
---|
Mirabegron 50 mg | 3.51 | 3.44 |
,Solifenacin 5 mg | 3.93 | 3.86 |
[back to top]
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)." (NCT01638000)
Timeframe: Baseline and Week 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 12 [N=876,871] | Final visit [N=897,889] |
---|
Mirabegron 50 mg | 2.92 | 2.88 |
,Solifenacin 5 mg | 3.07 | 3.03 |
[back to top]
[back to top]
Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 10 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 21 |
Solifenacin 5 mg + Mirabegron 25 mg | 19 |
Solifenacin 5 mg + Mirabegron 50 mg | 46 |
[back to top]
Change From Baseline in Postvoid Residual (PVR) Volume
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -4.95 | -2.83 | -2.53 | 0.63 | -0.42 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 5.88 | 5.07 | 5.29 | 3.96 | 3.96 |
,Solifenacin 5 mg + Mirabegron 25 mg | 13.78 | 11.05 | 6.51 | 7.31 | 8.00 |
,Solifenacin 5 mg + Mirabegron 50 mg | 4.36 | 1.87 | 1.17 | 3.60 | 3.17 |
[back to top]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT01745094)
Timeframe: From first dose of study drug up to weeks 16
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild | Moderate | Severe | Drug-related TEAEs | Deaths | Serious TEAEs | Drug-related Serious TEAEs | TEAEs leading to permanent discontinuation (PD) | Drug-related TEAEs leading to PD |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 23 | 22 | 1 | 0 | 6 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 21 | 20 | 1 | 0 | 6 | 0 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 42 | 40 | 1 | 1 | 12 | 0 | 5 | 1 | 3 | 2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 69 | 67 | 2 | 0 | 28 | 0 | 4 | 0 | 1 | 1 |
[back to top]
Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 10 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 17 |
Solifenacin 5 mg + Mirabegron 25 mg | 23 |
Solifenacin 5 mg + Mirabegron 50 mg | 40 |
[back to top]
Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT01745094)
Timeframe: Week 16
Intervention | Participants (Count of Participants) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 16 |
Solifenacin 2.5 mg + Mirabegron 50 mg | 13 |
Solifenacin 5 mg + Mirabegron 25 mg | 31 |
Solifenacin 5 mg + Mirabegron 50 mg | 38 |
[back to top]
Change From Baseline in OAB-q SF Total HRQL Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | units on a scale (Mean) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 15.14 | 17.54 | 17.34 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 9.31 | 16.72 | 16.72 |
,Solifenacin 5 mg + Mirabegron 25 mg | 12.43 | 14.72 | 13.88 |
,Solifenacin 5 mg + Mirabegron 50 mg | 6.14 | 12.72 | 12.56 |
[back to top]
Change From Baseline in OABSS Total Score
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | units on a scale (Mean) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -3.5 | -3.5 | -3.4 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -2.1 | -3.9 | -3.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | -3.5 | -3.6 | -3.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.5 | -4.0 | -4.0 |
[back to top]
[back to top]
Number of Participants Who Achieved Normalization for OABSS Total Score
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT01745094)
Timeframe: Week 8 and 16
Intervention | Participants (Count of Participants) |
---|
| Week 8 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 19 | 18 | 19 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 8 | 16 | 16 |
,Solifenacin 5 mg + Mirabegron 25 mg | 28 | 27 | 29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 26 | 48 | 49 |
[back to top]
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.85 | -1.06 | -1.31 | -1.22 | -1.07 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.55 | -0.73 | -1.04 | -1.08 | -1.08 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.12 | -1.26 | -1.03 | -1.32 | -1.32 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.64 | -0.76 | -0.93 | -1.08 | -1.06 |
[back to top]
Change From Baseline in the Number of Micturitions Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | micturitions (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.34 | -1.69 | -1.98 | -2.06 | -1.89 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.98 | -1.31 | -2.40 | -2.36 | -2.36 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.33 | -1.74 | -1.50 | -1.90 | -1.94 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.02 | -1.32 | -1.75 | -2.13 | -2.12 |
[back to top]
Change From Baseline in the Number of Nocturia Episodes Per Night
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 0.17 | -0.38 | -0.35 | -0.38 | -0.43 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.07 | -0.21 | -0.48 | -0.31 | -0.31 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.45 | -0.37 | -0.29 | -0.44 | -0.44 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.27 | -0.44 | -0.58 | -0.61 | -0.60 |
[back to top]
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | urge incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -0.87 | -1.17 | -1.30 | -1.07 | -0.97 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -0.50 | -0.65 | -0.94 | -1.00 | -1.00 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.77 | -1.07 | -0.84 | -1.11 | -1.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.82 | -0.72 | -0.91 | -0.96 | -0.94 |
[back to top]
Change From Baseline in the Number of Urgency Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 4, 8, 12, 16
Intervention | urgency episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | -1.15 | -1.77 | -1.95 | -1.77 | -1.57 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | -1.26 | -1.49 | -2.55 | -2.59 | -2.59 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.45 | -1.76 | -1.89 | -1.93 | -1.93 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.43 | -1.37 | -1.88 | -2.06 | -2.02 |
[back to top]
Change From Baseline in the Volume Voided Per Micturition
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT01745094)
Timeframe: Baseline and week 8, 16
Intervention | mL (Mean) |
---|
| Week 8 | Week16 | Week 16 (LOCF) |
---|
Solifenacin 2.5 mg + Mirabegron 25 mg | 22.120 | 28.532 | 29.865 |
,Solifenacin 2.5 mg + Mirabegron 50 mg | 19.380 | 33.031 | 33.031 |
,Solifenacin 5 mg + Mirabegron 25 mg | 33.781 | 35.780 | 34.118 |
,Solifenacin 5 mg + Mirabegron 50 mg | 24.821 | 36.921 | 36.957 |
[back to top]
BAT Activity as Measured by 18F-FDG PET/CT
difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue. (NCT01783470)
Timeframe: 60 min after FDG administration
Intervention | mL*SUVmean*g/mL (Median) |
---|
Placebo | 0.92 |
beta3-adrenergic Receptor (AR) | 132 |
[back to top]
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -16.68 | -22.86 | -27.90 | -26.89 |
,Solifenacin 10 mg | -15.82 | -19.34 | -24.09 | -23.59 |
,Solifenacin 5 mg | -13.79 | -18.36 | -22.31 | -21.93 |
[back to top]
Change From Baseline in Patient Perception Bladder Control (PPBC) Score
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.9 | -1.2 | -1.5 | -1.5 |
,Solifenacin 10 mg | -0.7 | -1.0 | -1.3 | -1.3 |
,Solifenacin 5 mg | -0.6 | -1.0 | -1.2 | -1.2 |
[back to top]
Change From Baseline in Post Void Residual (PVR) Volume
PVR Volume was assessed by bladder scan. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 1.545 | 2.245 | 6.356 | 5.478 |
,Solifenacin 10 mg | 7.308 | 7.232 | 6.552 | 7.354 |
,Solifenacin 5 mg | 2.821 | 1.117 | 2.337 | 3.046 |
[back to top]
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 1.2 | 1.5 | 1.9 | 1.8 |
,Solifenacin 10 mg | 1.1 | 1.3 | 1.6 | 1.6 |
,Solifenacin 5 mg | 0.8 | 1.2 | 1.4 | 1.4 |
[back to top]
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Combination (Solifenacin + Mirabegron) | -1.24 | -1.68 | -1.81 |
,Solifenacin 10 mg | -1.12 | -1.49 | -1.67 |
,Solifenacin 5 mg | -0.91 | -1.29 | -1.57 |
[back to top]
Number of Incontinence Episodes Reported During the 3-Day Diary
The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 5.81 | 4.55 | 4.03 | 4.25 |
,Solifenacin 10 mg | 6.41 | 5.28 | 4.62 | 4.72 |
,Solifenacin 5 mg | 6.68 | 5.43 | 4.56 | 4.87 |
[back to top]
Number of Nocturia Episodes Reported Over 3-Day Diary
The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 3.63 | 3.33 | 3.12 | 3.16 |
,Solifenacin 10 mg | 3.58 | 3.32 | 3.23 | 3.19 |
,Solifenacin 5 mg | 3.59 | 3.35 | 3.26 | 3.28 |
[back to top]
Number of Pads Used During the 3-Day Diary
The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | pads (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 4.80 | 3.64 | 3.23 | 3.29 |
,Solifenacin 10 mg | 5.41 | 4.50 | 4.07 | 4.17 |
,Solifenacin 5 mg | 5.69 | 4.71 | 4.13 | 4.27 |
[back to top]
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)). (NCT01908829)
Timeframe: End of treatment (up to 12 weeks)
Intervention | participants (Number) |
---|
| PIBS Very Much Improved | PIBS Much Improved | PIBS Minimally Improved | PIBS No Change | PIBS Minimally Worse | PIBS Much Worse | PIBS Very Much Worse | PIGH Very Much Improved | PIGH Much Improved | PIGH Minimally Improved | PIGH No Change | PIGH Minimally Worse | PIGH Much Worse | PIGH Very Much Worse | CIBS Very Much Improved | CIBS Much Improved | CIBS Minimally Improved | CIBS No Change | CIBS Minimally Worse | CIBS Much Worse | CIBS Very Much Worse |
---|
Combination (Solifenacin + Mirabegron) | 227 | 257 | 135 | 25 | 7 | 4 | 0 | 144 | 239 | 143 | 113 | 14 | 1 | 1 | 184 | 311 | 141 | 23 | 4 | 4 | 3 |
,Solifenacin 10 mg | 171 | 284 | 152 | 56 | 4 | 6 | 1 | 108 | 244 | 146 | 160 | 10 | 4 | 2 | 141 | 329 | 155 | 40 | 5 | 5 | 4 |
,Solifenacin 5 mg | 152 | 264 | 170 | 55 | 11 | 4 | 1 | 104 | 236 | 147 | 142 | 23 | 4 | 1 | 118 | 316 | 164 | 56 | 8 | 3 | 3 |
[back to top]
Number of Participants With Adverse Events (AEs)
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. (NCT01908829)
Timeframe: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Intervention | Participants (Count of Participants) |
---|
| AEs | Drug-related AEs | Serious Adverse Events (SAEs) | Drug-related SAEs | AEs Leading to Perm. Disc. of Study Drug | Drug-related AEs Leading to Perm. Disc. of Drug | Deaths |
---|
Combination (Solifenacin + Mirabegron) | 260 | 141 | 13 | 1 | 11 | 9 | 0 |
,Solifenacin 10 mg | 283 | 161 | 15 | 3 | 11 | 9 | 0 |
,Solifenacin 5 mg | 241 | 125 | 10 | 0 | 11 | 10 | 0 |
[back to top]
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| Not anxious -> not anxious | Not anxious -> slightly anxious | Not anxious -> moderately anxious | Not anxious -> severely anxious | Not anxious-> extremely anxious | Not anxious -> no data | Slightly anxious -> not anxious | Slightly anxious -> slightly anxious | Slightly anxious -> moderately anxious | Slightly anxious -> severely anxious | Slightly anxious -> extremely anxious | Slightly anxious -> no data | Moderately anxious -> not anxious | Moderately anxious -> slightly anxious | Moderately anxious -> moderately anxious | Moderately anxious -> severely anxious | Moderately anxious -> extremely anxious | Moderately anxious -> no data | Severely anxious -> not anxious | Severely anxious -> slightly anxious | Severely anxious -> moderately anxious | Severely anxious -> severely anxious | Severely anxious -> extremely anxious | Severely anxious -> no data | Extremely anxious -> not anxious | Extremely anxious -> slightly anxious | Extremely anxious -> moderately anxious | Extremely anxious -> severely anxious | Extremely anxious -> extremely anxious | Extremely anxious -> no data | No data -> not anxious | No data -> slightly anxious | No data -> moderately anxious | No data -> severely anxious | No data -> extremely anxious | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 322 | 43 | 11 | 2 | 0 | 4 | 107 | 56 | 13 | 1 | 0 | 1 | 36 | 36 | 22 | 3 | 0 | 0 | 10 | 9 | 6 | 5 | 0 | 0 | 1 | 2 | 4 | 4 | 1 | 1 | 5 | 0 | 1 | 0 | 0 | 1 |
,Solifenacin 10 mg | 307 | 43 | 15 | 3 | 0 | 3 | 90 | 69 | 23 | 2 | 0 | 2 | 34 | 33 | 17 | 1 | 1 | 0 | 8 | 5 | 11 | 7 | 0 | 0 | 1 | 1 | 3 | 1 | 1 | 0 | 11 | 5 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg | 300 | 39 | 17 | 2 | 0 | 3 | 99 | 60 | 11 | 2 | 0 | 2 | 38 | 40 | 26 | 7 | 3 | 0 | 8 | 5 | 6 | 8 | 3 | 0 | 4 | 1 | 2 | 1 | 2 | 0 | 13 | 2 | 1 | 0 | 0 | 0 |
[back to top]
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No pain -> no pain | No pain -> slight pain | No pain -> moderate pain | No pain -> severe pain | No pain -> extreme pain | No pain -> no data | Slight pain -> no pain | Slight pain -> slight pain | Slight pain -> moderate pain | Slight pain -> severe pain | Slight pain -> extreme pain | Slight pain -> no data | Moderate pain -> no pain | Moderate pain -> slight pain | Moderate pain -> moderate pain | Moderate pain -> severe pain | Moderate pain -> extreme pain | Moderate pain -> no data | Severe pain -> no pain | Severe pain -> slight pain | Severe pain -> moderate pain | Severe pain -> severe pain | Severe pain -> extreme pain | Severe pain -> no data | Extreme pain -> no pain | Extreme pain -> slight pain | Extreme pain -> moderate pain | Extreme pain -> severe pain | Extreme pain -> extreme pain | Extreme pain -> no data | No data -> no pain | No data -> slight pain | No data -> moderate pain | No data -> severe pain | No data -> extreme pain | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 299 | 45 | 12 | 3 | 0 | 4 | 79 | 58 | 28 | 0 | 1 | 0 | 39 | 37 | 34 | 7 | 0 | 2 | 7 | 12 | 11 | 10 | 0 | 0 | 4 | 0 | 1 | 6 | 1 | 0 | 4 | 1 | 1 | 0 | 0 | 1 |
,Solifenacin 10 mg | 283 | 51 | 17 | 2 | 1 | 3 | 81 | 55 | 31 | 5 | 0 | 2 | 21 | 39 | 39 | 8 | 0 | 0 | 10 | 4 | 16 | 9 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 11 | 4 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg | 290 | 62 | 14 | 9 | 0 | 4 | 82 | 64 | 17 | 2 | 2 | 0 | 36 | 36 | 30 | 4 | 1 | 1 | 4 | 7 | 16 | 4 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 8 | 3 | 5 | 0 | 0 | 0 |
[back to top]
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 548 | 28 | 0 | 3 | 0 | 6 | 37 | 23 | 9 | 1 | 0 | 0 | 12 | 9 | 11 | 0 | 0 | 0 | 7 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 548 | 25 | 7 | 2 | 0 | 4 | 32 | 22 | 9 | 0 | 0 | 1 | 7 | 5 | 12 | 2 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 0 | 0 | 0 |
,Solifenacin 5 mg | 541 | 26 | 14 | 0 | 0 | 5 | 25 | 24 | 7 | 0 | 0 | 0 | 16 | 9 | 7 | 2 | 0 | 0 | 5 | 2 | 1 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 0 | 0 |
[back to top]
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 397 | 38 | 12 | 1 | 0 | 4 | 75 | 46 | 12 | 1 | 0 | 0 | 29 | 22 | 22 | 3 | 1 | 2 | 9 | 7 | 7 | 5 | 0 | 0 | 2 | 1 | 3 | 1 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 379 | 42 | 11 | 1 | 1 | 3 | 78 | 37 | 15 | 3 | 0 | 2 | 25 | 28 | 21 | 4 | 0 | 0 | 12 | 1 | 9 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 1 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg | 384 | 30 | 19 | 4 | 0 | 3 | 81 | 45 | 16 | 1 | 1 | 1 | 35 | 20 | 18 | 3 | 0 | 1 | 8 | 5 | 6 | 7 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 11 | 4 | 1 | 0 | 0 | 0 |
[back to top]
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> extreme problems | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> extreme problems | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> extreme problems | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> extreme problems | Severe problems -> no data | Extreme problems -> no problems | Extreme problems -> slight problems | Extreme problems -> moderate problems | Extreme problems -> severe problems | Extreme problems -> extreme problems | Extreme problems -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> extreme problems | No data -> no data |
---|
Combination (Solifenacin + Mirabegron) | 409 | 33 | 14 | 0 | 0 | 2 | 52 | 43 | 15 | 1 | 0 | 2 | 24 | 25 | 28 | 2 | 0 | 1 | 7 | 6 | 17 | 12 | 0 | 1 | 3 | 1 | 1 | 1 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 10 mg | 374 | 36 | 11 | 4 | 0 | 5 | 60 | 40 | 16 | 3 | 0 | 0 | 25 | 23 | 40 | 7 | 0 | 0 | 2 | 7 | 11 | 14 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 13 | 1 | 3 | 0 | 0 | 0 |
,Solifenacin 5 mg | 370 | 35 | 11 | 7 | 1 | 4 | 58 | 46 | 28 | 3 | 0 | 0 | 36 | 18 | 28 | 3 | 1 | 0 | 8 | 7 | 11 | 10 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 9 | 4 | 3 | 0 | 0 | 0 |
[back to top]
Number of UI Episodes Reported During the 3-Day Diary
Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | UI episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 4.96 | 3.55 | 3.10 | 3.33 |
,Solifenacin 10 mg | 5.50 | 4.50 | 3.91 | 3.96 |
,Solifenacin 5 mg | 5.86 | 4.76 | 3.78 | 4.00 |
[back to top]
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
Micturitions were defined as voluntary urinations (excluding incontinence only episodes). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 21.0 | 28.1 | 31.4 | 30.2 |
,Solifenacin 10 mg | 20.2 | 26.3 | 28.0 | 27.7 |
,Solifenacin 5 mg | 18.7 | 22.4 | 24.8 | 25.0 |
[back to top]
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 61.1 | 70.1 | 77.9 | 76.5 |
,Solifenacin 10 mg | 56.3 | 64.6 | 72.7 | 71.9 |
,Solifenacin 5 mg | 52.1 | 62.1 | 70.4 | 69.5 |
[back to top]
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 52.6 | 63.6 | 70.5 | 68.6 |
,Solifenacin 10 mg | 48.1 | 53.8 | 60.4 | 60.1 |
,Solifenacin 5 mg | 44.5 | 54.8 | 60.8 | 60.6 |
[back to top]
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 67.9 | 77.2 | 83.5 | 81.7 |
,Solifenacin 10 mg | 61.9 | 69.1 | 75.4 | 74.6 |
,Solifenacin 5 mg | 58.2 | 66.4 | 72.1 | 71.7 |
[back to top]
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 26.6 | 39.5 | 51.8 | 49.8 |
,Solifenacin 10 mg | 21.6 | 31.8 | 43.8 | 43.2 |
,Solifenacin 5 mg | 21.6 | 31.5 | 39.8 | 39.1 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Postbaseline
Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 23.5 | 40.4 | 47.3 | 46.0 |
,Solifenacin 10 mg | 22.1 | 34.3 | 40.7 | 40.2 |
,Solifenacin 5 mg | 20.0 | 31.6 | 39.5 | 37.9 |
[back to top]
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Incontinence was defined as any involuntary leakage of urine. (NCT01908829)
Timeframe: Weeks 4, 8 and 12
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 52.5 | 66.9 | 72.4 | 71.2 |
,Solifenacin 10 mg | 49.0 | 61.8 | 66.9 | 66.6 |
,Solifenacin 5 mg | 43.3 | 57.6 | 64.0 | 63.1 |
[back to top]
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. (NCT01908829)
Timeframe: Baseline and end of treatment (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
Combination (Solifenacin + Mirabegron) | -1.8 |
Solifenacin 5 mg | -1.53 |
Solifenacin 10 mg | -1.67 |
[back to top]
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. (NCT01908829)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | micturitions (Least Squares Mean) |
---|
Combination (Solifenacin + Mirabegron) | -0.96 |
Solifenacin 5 mg | -0.52 |
Solifenacin 10 mg | -0.71 |
[back to top]
Change From Baseline in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.95 | -1.36 | -1.63 | -1.59 |
,Solifenacin 10 mg | -0.79 | -1.00 | -1.11 | -1.12 |
,Solifenacin 5 mg | -0.69 | -0.94 | -1.16 | -1.14 |
[back to top]
Change From Baseline in Mean Number of Nocturia Episodes
Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -0.28 | -0.37 | -0.46 | -0.43 |
,Solifenacin 10 mg | -0.29 | -0.37 | -0.41 | -0.41 |
,Solifenacin 5 mg | -0.27 | -0.35 | -0.38 | -0.37 |
[back to top]
Change From Baseline in Mean Number of Pads Per 24 Hours
The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.12 | -1.50 | -1.65 | -1.66 |
,Solifenacin 10 mg | -1.04 | -1.36 | -1.43 | -1.43 |
,Solifenacin 5 mg | -0.86 | -1.17 | -1.38 | -1.35 |
[back to top]
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.84 | -2.64 | -2.97 | -2.95 |
,Solifenacin 10 mg | -1.74 | -2.29 | -2.55 | -2.54 |
,Solifenacin 5 mg | -1.39 | -2.00 | -2.44 | -2.41 |
[back to top]
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | UI episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | -1.26 | -1.70 | -1.84 | -1.82 |
,Solifenacin 10 mg | -1.14 | -1.45 | -1.62 | -1.63 |
,Solifenacin 5 mg | -0.91 | -1.25 | -1.58 | -1.54 |
[back to top]
Change From Baseline in Mean Volume Voided (MVV) Per Micturition
MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period. (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 15.06 | 25.21 | 29.54 | 28.05 |
,Solifenacin 10 mg | 14.99 | 21.08 | 20.99 | 20.30 |
,Solifenacin 5 mg | 11.20 | 14.02 | 17.16 | 16.52 |
[back to top]
[back to top]
Change From Baseline in OAB-q HRQL Subscale Score: Concern
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week EoT |
---|
Combination (Solifenacin + Mirabegron) | 13.79 | 18.87 | 22.85 | 22.28 |
,Solifenacin 10 mg | 13.82 | 15.88 | 19.67 | 19.28 |
,Solifenacin 5 mg | 11.85 | 16.36 | 19.24 | 19.00 |
[back to top]
Change From Baseline in OAB-q HRQL Subscale Score: Coping
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 15.17 | 20.82 | 25.16 | 24.48 |
,Solifenacin 10 mg | 14.25 | 16.87 | 20.20 | 19.90 |
,Solifenacin 5 mg | 12.27 | 17.47 | 20.45 | 20.19 |
[back to top]
Change From Baseline in OAB-q HRQL Subscale Score: Sleep
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week EoT |
---|
Combination (Solifenacin + Mirabegron) | 11.58 | 16.18 | 20.00 | 19.16 |
,Solifenacin 10 mg | 11.16 | 13.72 | 16.84 | 16.55 |
,Solifenacin 5 mg | 11.04 | 14.57 | 17.74 | 17.30 |
[back to top]
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). (NCT01908829)
Timeframe: Baseline and weeks 4, 8 & 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Combination (Solifenacin + Mirabegron) | 9.58 | 11.93 | 14.70 | 14.39 |
,Solifenacin 10 mg | 8.95 | 10.16 | 11.98 | 11.72 |
,Solifenacin 5 mg | 7.85 | 10.84 | 12.08 | 11.91 |
[back to top]
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of activity impairment (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -16.89 | -16.72 |
,Mirabegron 50 mg | -14.99 | -15.05 |
,Placebo | -11.49 | -11.55 |
,Solifenacin 5 mg | -16.19 | -16.05 |
,Solifenacin 5 mg + Mirabegron 25 mg | -19.60 | -19.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -18.92 | -18.76 |
[back to top]
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of impairment while working (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -14.96 | -14.96 |
,Mirabegron 50 mg | -12.25 | -12.37 |
,Placebo | -11.27 | -11.18 |
,Solifenacin 5 mg | -10.85 | -10.98 |
,Solifenacin 5 mg + Mirabegron 25 mg | -14.69 | -14.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.07 | -12.87 |
[back to top]
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment
(NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of overall work impairment (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -15.70 | -15.70 |
,Mirabegron 50 mg | -12.92 | -13.05 |
,Placebo | -12.23 | -12.14 |
,Solifenacin 5 mg | -12.31 | -12.42 |
,Solifenacin 5 mg + Mirabegron 25 mg | -16.31 | -16.07 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.97 | -13.76 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | nnHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.08 | 0.15 | 0.27 |
,Mirabegron 50 mg | -0.20 | -1.90 | -0.96 |
,Placebo | -0.76 | 0.53 | 0.87 |
,Solifenacin 5 mg | -1.60 | -0.66 | -1.67 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.39 | -1.24 | -0.98 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.56 | 0.46 | 0.52 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)
Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | -0.86 | -0.36 | -0.97 | -0.93 | -0.54 | -1.39 | -1.41 | -0.98 | -2.00 |
,Mirabegron 50 mg | 0.22 | -0.33 | 0.40 | -0.19 | -0.40 | -0.03 | -0.11 | -0.69 | 0.08 |
,Placebo | -0.70 | -1.25 | -0.12 | -0.80 | -0.85 | -0.49 | -0.96 | -1.17 | -0.41 |
,Solifenacin 5 mg | 0.25 | -0.77 | 0.48 | 0.43 | -0.33 | 0.92 | 0.05 | -0.79 | 0.71 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.03 | -0.40 | 0.93 | -0.37 | -0.06 | 0.23 | -0.02 | -0.18 | 0.56 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.38 | 0.07 | 0.47 | 0.31 | -0.18 | 0.49 | 0.25 | -0.36 | 0.61 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | beats per minute (bpm) (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | 1.14 | 1.19 | 0.98 | 0.38 | 0.25 | 0.21 | 0.63 | 0.37 | 0.82 |
,Mirabegron 50 mg | 2.32 | 3.52 | 1.77 | 1.19 | 2.12 | 0.19 | 1.67 | 2.64 | 0.75 |
,Placebo | -0.83 | -0.70 | -0.72 | 0.70 | 0.89 | 0.34 | 0.41 | 0.45 | 0.39 |
,Solifenacin 5 mg | 0.36 | 0.37 | 1.09 | 0.12 | -0.13 | 0.06 | 0.02 | -0.07 | 0.45 |
,Solifenacin 5 mg + Mirabegron 25 mg | 0.40 | -0.05 | 0.86 | 0.94 | 0.84 | 0.76 | 0.85 | 0.32 | 1.21 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.69 | 0.61 | 0.86 | 1.44 | 1.36 | 1.52 | 1.52 | 1.24 | 1.64 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)
Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4: 24-hour mean | Week 4: mean daytime | Week 4: mean nighttime | Week 12: 24-hour mean | Week 12: mean daytime | Week 12: mean nighttime | End of treatment: 24-hour mean | End of treatment: mean daytime | End of treatment: mean nighttime |
---|
Mirabegron 25 mg | -2.04 | -1.19 | -1.14 | -2.70 | -2.53 | -2.81 | -3.44 | -3.29 | -3.48 |
,Mirabegron 50 mg | 0.96 | -0.67 | 1.42 | -1.75 | -2.14 | -0.77 | -1.14 | -1.92 | -0.60 |
,Placebo | -1.00 | -1.55 | -0.51 | -1.97 | -2.22 | -1.03 | -1.73 | -2.01 | -1.00 |
,Solifenacin 5 mg | 1.03 | -1.13 | 0.41 | 0.40 | -2.09 | 1.31 | 0.37 | -2.17 | 1.42 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.85 | -1.63 | 1.14 | -0.71 | -0.39 | 0.11 | -0.52 | -0.68 | 0.41 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.31 | -0.53 | 0.54 | 0.40 | -0.71 | 0.79 | -0.08 | -1.28 | 0.91 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.09 | -0.45 | -0.71 |
,Mirabegron 50 mg | -0.65 | -0.31 | -0.71 |
,Placebo | -1.24 | -1.74 | -1.85 |
,Solifenacin 5 mg | -0.48 | -1.49 | -1.22 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.22 | 0.48 | 0.44 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.71 | -0.03 | -0.80 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 2.39 | 1.22 | 0.82 |
,Mirabegron 50 mg | 3.68 | 1.87 | 3.41 |
,Placebo | 0.02 | 0.10 | -0.43 |
,Solifenacin 5 mg | 0.47 | 0.37 | -1.25 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.91 | 0.15 | 0.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.67 | 1.39 | 1.25 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.34 | -2.13 | -2.19 |
,Mirabegron 50 mg | -1.03 | -1.64 | -1.94 |
,Placebo | -2.71 | -4.86 | -4.40 |
,Solifenacin 5 mg | -1.77 | -3.15 | -3.64 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.55 | -0.26 | -0.61 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.47 | 0.60 | -0.98 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.46 | -0.04 | 0.45 |
,Mirabegron 50 mg | 1.54 | 1.15 | 1.14 |
,Placebo | 1.16 | 3.35 | 2.48 |
,Solifenacin 5 mg | 0.78 | 3.49 | 3.16 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.68 | -0.53 | -0.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.51 | 1.48 | 1.80 |
[back to top]
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.14 | -2.45 | -1.38 |
,Mirabegron 50 mg | -0.69 | -4.55 | -2.30 |
,Placebo | -0.71 | 1.18 | 1.15 |
,Solifenacin 5 mg | 0.85 | -1.63 | -0.97 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.61 | 0.68 | 0.25 |
,Solifenacin 5 mg + Mirabegron 50 mg | 0.41 | 0.62 | 0.68 |
[back to top]
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -1.07 | -1.51 | -1.76 |
,Mirabegron 50 mg | -1.24 | -1.57 | -1.81 |
,Placebo | -0.74 | -1.20 | -1.30 |
,Solifenacin 5 mg | -1.24 | -1.66 | -1.80 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.38 | -1.79 | -2.08 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.50 | -1.84 | -1.98 |
[back to top]
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | micturitions (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -1.46 | -1.95 | -2.01 |
,Mirabegron 50 mg | -1.44 | -1.89 | -2.03 |
,Placebo | -1.02 | -1.43 | -1.51 |
,Solifenacin 5 mg | -1.39 | -1.84 | -2.22 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.67 | -2.23 | -2.47 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.91 | -2.42 | -2.60 |
[back to top]
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition
(NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | mL (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | 10.08 | 10.96 | 12.88 |
,Mirabegron 50 mg | 15.52 | 17.73 | 22.40 |
,Placebo | 6.95 | 9.00 | 8.70 |
,Solifenacin 5 mg | 24.23 | 27.55 | 31.89 |
,Solifenacin 5 mg + Mirabegron 25 mg | 25.54 | 32.94 | 35.52 |
,Solifenacin 5 mg + Mirabegron 50 mg | 28.99 | 36.51 | 41.28 |
[back to top]
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | -17.05 | -22.79 | -24.44 |
,Mirabegron 50 mg | -18.98 | -23.54 | -26.80 |
,Placebo | -13.84 | -17.35 | -19.94 |
,Solifenacin 5 mg | -19.53 | -24.69 | -26.72 |
,Solifenacin 5 mg + Mirabegron 25 mg | -23.46 | -29.10 | -31.70 |
,Solifenacin 5 mg + Mirabegron 50 mg | -25.19 | -30.04 | -33.15 |
[back to top]
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 25 mg | 1.68 | 2.16 | 2.24 |
,Mirabegron 50 mg | 1.77 | 2.09 | 2.23 |
,Placebo | 1.14 | 1.50 | 1.47 |
,Solifenacin 5 mg | 1.82 | 2.20 | 2.32 |
,Solifenacin 5 mg + Mirabegron 25 mg | 2.06 | 2.48 | 2.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.13 | 2.48 | 2.63 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatmemt |
---|
Mirabegron 25 mg | -0.31 | -0.37 | -0.38 | -0.40 |
,Mirabegron 50 mg | -0.25 | -0.35 | -0.39 | -0.39 |
,Placebo | -0.17 | -0.27 | -0.26 | -0.27 |
,Solifenacin 5 mg | -0.24 | -0.36 | -0.41 | -0.39 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.33 | -0.44 | -0.49 | -0.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.35 | -0.50 | -0.56 | -0.56 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8 and 12 (up to 12 weeks)
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.81 | -1.20 | -1.30 | -1.26 |
,Mirabegron 50 mg | -1.12 | -1.24 | -1.37 | -1.41 |
,Placebo | -0.52 | -0.82 | -0.92 | -0.94 |
,Solifenacin 5 mg | -1.19 | -1.53 | -1.56 | -1.53 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.09 | -1.36 | -1.54 | -1.53 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.23 | -1.51 | -1.59 | -1.58 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.95 | -2.54 | -2.85 | -2.74 |
,Mirabegron 50 mg | -1.91 | -2.43 | -2.70 | -2.63 |
,Placebo | -1.34 | -1.85 | -2.05 | -2.06 |
,Solifenacin 5 mg | -2.14 | -2.90 | -3.11 | -3.05 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.42 | -3.13 | -3.45 | -3.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.66 | -3.28 | -3.50 | -3.51 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -1.00 | -1.43 | -1.63 | -1.58 |
,Mirabegron 50 mg | -1.15 | -1.44 | -1.67 | -1.62 |
,Placebo | -0.78 | -1.15 | -1.29 | -1.33 |
,Solifenacin 5 mg | -1.19 | -1.56 | -1.72 | -1.71 |
,Solifenacin 5 mg + Mirabegron 25 mg | -1.35 | -1.74 | -1.99 | -1.95 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.47 | -1.79 | -1.93 | -1.94 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -7.59 | -10.57 | -12.33 | -11.93 |
,Mirabegron 50 mg | -8.99 | -10.97 | -12.58 | -12.39 |
,Placebo | -5.23 | -8.79 | -9.05 | -9.42 |
,Solifenacin 5 mg | -8.92 | -11.89 | -12.75 | -12.65 |
,Solifenacin 5 mg + Mirabegron 25 mg | -9.62 | -12.53 | -14.50 | -14.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.51 | -12.78 | -13.94 | -13.98 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -2.25 | -2.70 | -2.77 | -2.91 |
,Mirabegron 50 mg | -1.80 | -2.41 | -2.73 | -2.75 |
,Placebo | -1.27 | -1.94 | -1.95 | -2.05 |
,Solifenacin 5 mg | -1.79 | -2.60 | -2.89 | -2.81 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.39 | -3.13 | -3.49 | -3.42 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.50 | -3.48 | -3.96 | -3.96 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Intervention | pads (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -5.68 | -8.44 | -9.06 | -8.76 |
,Mirabegron 50 mg | -7.83 | -8.43 | -9.41 | -9.80 |
,Placebo | -3.69 | -6.24 | -6.29 | -6.60 |
,Solifenacin 5 mg | -8.23 | -10.67 | -10.80 | -10.63 |
,Solifenacin 5 mg + Mirabegron 25 mg | -7.61 | -9.49 | -10.66 | -10.67 |
,Solifenacin 5 mg + Mirabegron 50 mg | -8.58 | -10.59 | -11.23 | -11.21 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes
(NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -7.07 | -9.93 | -11.39 | -11.03 |
,Mirabegron 50 mg | -8.39 | -10.07 | -11.66 | -11.44 |
,Placebo | -5.49 | -8.30 | -8.96 | -9.26 |
,Solifenacin 5 mg | -8.53 | -11.10 | -12.10 | -12.03 |
,Solifenacin 5 mg + Mirabegron 25 mg | -9.44 | -12.18 | -13.87 | -13.64 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.23 | -12.18 | -13.53 | -13.64 |
[back to top]
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern
The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 15.89 | 20.63 | 22.37 | 21.55 |
,Mirabegron 50 mg | 17.39 | 20.55 | 23.62 | 23.07 |
,Placebo | 11.24 | 16.10 | 17.53 | 16.98 |
,Solifenacin 5 mg | 17.18 | 20.96 | 23.19 | 22.65 |
,Solifenacin 5 mg + Mirabegron 25 mg | 20.48 | 25.26 | 27.53 | 26.89 |
,Solifenacin 5 mg + Mirabegron 50 mg | 21.09 | 25.65 | 28.24 | 27.47 |
[back to top]
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence-free days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 2.48 | 3.17 | 3.69 | 3.51 |
,Mirabegron 50 mg | 2.98 | 3.63 | 3.96 | 3.89 |
,Placebo | 2.25 | 2.92 | 3.19 | 3.16 |
,Solifenacin 5 mg | 2.74 | 3.31 | 3.68 | 3.61 |
,Solifenacin 5 mg + Mirabegron 25 mg | 3.08 | 3.88 | 4.33 | 4.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | 3.37 | 4.01 | 4.25 | 4.23 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep
The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 12.70 | 16.39 | 18.04 | 17.51 |
,Mirabegron 50 mg | 13.80 | 17.33 | 19.16 | 19.11 |
,Placebo | 9.28 | 13.58 | 14.40 | 14.17 |
,Solifenacin 5 mg | 13.08 | 16.43 | 18.35 | 17.97 |
,Solifenacin 5 mg + Mirabegron 25 mg | 15.97 | 20.29 | 22.97 | 22.39 |
,Solifenacin 5 mg + Mirabegron 50 mg | 16.66 | 20.49 | 22.76 | 22.39 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social
The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 9.04 | 11.50 | 13.43 | 13.04 |
,Mirabegron 50 mg | 10.19 | 12.34 | 15.35 | 14.87 |
,Placebo | 7.07 | 10.65 | 10.84 | 10.56 |
,Solifenacin 5 mg | 9.89 | 12.02 | 13.74 | 13.57 |
,Solifenacin 5 mg + Mirabegron 25 mg | 11.55 | 14.89 | 16.16 | 15.84 |
,Solifenacin 5 mg + Mirabegron 50 mg | 11.25 | 14.73 | 16.08 | 15.82 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.72 | -1.07 | -1.23 | -1.18 |
,Mirabegron 50 mg | -0.83 | -1.12 | -1.34 | -1.31 |
,Placebo | -0.54 | -0.80 | -0.95 | -0.91 |
,Solifenacin 5 mg | -0.81 | -1.18 | -1.32 | -1.27 |
,Solifenacin 5 mg + Mirabegron 25 mg | -0.99 | -1.32 | -1.57 | -1.53 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.07 | -1.48 | -1.72 | -1.66 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 1.6 | -0.4 | 1.0 | 0.7 |
,Mirabegron 50 mg | -2.1 | -0.6 | 0.0 | -0.8 |
,Placebo | -0.8 | -1.9 | -1.0 | -1.0 |
,Solifenacin 5 mg | 5.8 | 5.4 | 4.7 | 4.8 |
,Solifenacin 5 mg + Mirabegron 25 mg | 7.2 | 7.0 | 7.9 | 9.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 10.6 | 9.9 | 9.6 | 11.0 |
[back to top]
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 19.15 | 19.52 | 19.29 |
,Mirabegron 50 mg | 20.41 | 20.41 | 20.71 |
,Placebo | 18.78 | 19.68 | 20.29 |
,Solifenacin 5 mg | 20.02 | 21.18 | 20.47 |
,Solifenacin 5 mg + Mirabegron 25 mg | 20.74 | 19.26 | 20.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 20.27 | 20.01 | 20.36 |
[back to top]
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | bpm (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 23.86 | 23.54 | 24.12 |
,Mirabegron 50 mg | 25.12 | 26.03 | 26.23 |
,Placebo | 22.34 | 22.63 | 23.01 |
,Solifenacin 5 mg | 24.28 | 23.52 | 23.33 |
,Solifenacin 5 mg + Mirabegron 25 mg | 21.48 | 22.60 | 22.66 |
,Solifenacin 5 mg + Mirabegron 50 mg | 21.80 | 24.08 | 24.14 |
[back to top]
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT
Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means. (NCT01972841)
Timeframe: Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Intervention | mmHg (Least Squares Mean) |
---|
| Week 4 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 31.14 | 30.68 | 30.65 |
,Mirabegron 50 mg | 38.20 | 32.88 | 33.53 |
,Placebo | 34.05 | 33.21 | 34.98 |
,Solifenacin 5 mg | 35.16 | 35.11 | 34.95 |
,Solifenacin 5 mg + Mirabegron 25 mg | 32.88 | 33.53 | 34.70 |
,Solifenacin 5 mg + Mirabegron 50 mg | 32.80 | 32.82 | 32.55 |
[back to top]
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 27.9 | 44.7 | 51.7 | 48.5 |
,Mirabegron 50 mg | 37.7 | 50.1 | 54.9 | 53.9 |
,Placebo | 23.2 | 35.6 | 40.6 | 40.9 |
,Solifenacin 5 mg | 34.5 | 51.3 | 56.9 | 56.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 39.9 | 53.8 | 62.0 | 59.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 42.9 | 57.7 | 65.4 | 63.8 |
[back to top]
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 0.84 | 1.20 | 1.47 | 1.40 |
,Mirabegron 50 mg | 0.87 | 1.23 | 1.50 | 1.47 |
,Placebo | 0.64 | 0.85 | 0.98 | 1.01 |
,Solifenacin 5 mg | 0.91 | 1.31 | 1.60 | 1.59 |
,Solifenacin 5 mg + Mirabegron 25 mg | 1.21 | 1.75 | 2.12 | 2.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 1.32 | 1.89 | 2.15 | 2.12 |
[back to top]
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 8.46 | 8.07 | 7.99 | 7.79 |
,Mirabegron 50 mg | 9.11 | 8.61 | 8.34 | 8.14 |
,Placebo | 9.62 | 8.99 | 8.91 | 8.83 |
,Solifenacin 5 mg | 9.22 | 8.37 | 8.17 | 8.12 |
,Solifenacin 5 mg + Mirabegron 25 mg | 8.40 | 7.63 | 7.26 | 7.33 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.09 | 7.11 | 6.67 | 6.67 |
[back to top]
Number of Pads Used at Weeks 4, 8, 12 and EoT
The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8 and 12 (up to 12 weeks)
Intervention | pads (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.46 | 10.79 | 9.65 | 10.15 |
,Mirabegron 50 mg | 10.05 | 9.53 | 8.44 | 8.16 |
,Placebo | 15.62 | 12.75 | 12.62 | 12.29 |
,Solifenacin 5 mg | 11.41 | 8.45 | 8.21 | 8.53 |
,Solifenacin 5 mg + Mirabegron 25 mg | 9.71 | 8.07 | 6.60 | 7.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.34 | 7.58 | 6.64 | 6.80 |
[back to top]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing. (NCT01972841)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Drug-related TEAEs | Deaths | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to discontinuation | Drug-related TEAEs leading to discontinuation |
---|
Mirabegron 25 mg | 135 | 37 | 0 | 6 | 1 | 7 | 4 |
,Mirabegron 50 mg | 147 | 52 | 0 | 5 | 1 | 10 | 6 |
,Placebo | 145 | 45 | 0 | 8 | 0 | 9 | 7 |
,Solifenacin 5 mg | 149 | 63 | 0 | 3 | 0 | 7 | 5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 345 | 157 | 0 | 12 | 2 | 20 | 17 |
,Solifenacin 5 mg + Mirabegron 50 mg | 314 | 150 | 0 | 19 | 3 | 22 | 19 |
[back to top]
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.36 | 10.65 | 8.84 | 9.37 |
,Mirabegron 50 mg | 11.46 | 10.09 | 8.32 | 8.63 |
,Placebo | 15.76 | 12.77 | 12.00 | 11.69 |
,Solifenacin 5 mg | 13.19 | 10.41 | 9.29 | 9.29 |
,Solifenacin 5 mg + Mirabegron 25 mg | 10.22 | 7.58 | 5.86 | 6.25 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.33 | 7.31 | 6.27 | 6.15 |
[back to top]
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 12: Very much improved | Week 12: Much improved | Week 12: Minimally improved | Week 12: No change | Week 12: Minimally worse | Week 12: Much worse | Week 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 25 mg | 13.9 | 32.9 | 26.8 | 12.9 | 1.5 | 1.0 | 0.5 | 13.9 | 33.2 | 26.8 | 13.4 | 1.5 | 1.0 | 0.5 |
,Mirabegron 50 mg | 15.1 | 34.8 | 26.5 | 9.7 | 2.2 | 1.2 | 0.7 | 15.1 | 34.8 | 27.0 | 10.2 | 2.2 | 1.2 | 0.7 |
,Placebo | 8.4 | 29.7 | 29.7 | 17.5 | 4.1 | 1.0 | 0.5 | 8.4 | 30.4 | 29.9 | 18.2 | 4.1 | 1.0 | 0.5 |
,Solifenacin 5 mg | 13.5 | 40.5 | 25.8 | 8.9 | 1.7 | 0.5 | 0.5 | 13.5 | 41.0 | 26.3 | 9.6 | 1.7 | 0.7 | 0.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 19.8 | 39.8 | 22.2 | 7.7 | 0.8 | 0.2 | 0.2 | 20.0 | 40.0 | 22.6 | 7.9 | 0.8 | 0.4 | 0.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 27.1 | 34.0 | 20.7 | 7.3 | 0.8 | 0 | 0.5 | 27.1 | 34.6 | 21.3 | 7.4 | 0.8 | 0 | 0.6 |
[back to top]
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8 , 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 30.8 | 37.9 | 42.3 | 42.1 |
,Mirabegron 50 mg | 25.4 | 34.5 | 40.7 | 40.1 |
,Placebo | 24.1 | 28.7 | 29.7 | 31.1 |
,Solifenacin 5 mg | 31.1 | 37.0 | 44.9 | 45.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 36.0 | 45.3 | 50.8 | 51.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 37.7 | 49.0 | 53.1 | 52.6 |
[back to top]
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 28.3 | 43.2 | 48.3 | 46.0 |
,Mirabegron 50 mg | 39.8 | 46.1 | 53.5 | 52.9 |
,Placebo | 23.2 | 32.9 | 39.2 | 39.1 |
,Solifenacin 5 mg | 37.7 | 48.4 | 54.8 | 54.0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 40.4 | 54.1 | 61.6 | 59.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.5 | 53.0 | 59.2 | 58.2 |
[back to top]
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 34.8 | 50.0 | 55.7 | 54.0 |
,Mirabegron 50 mg | 45.7 | 51.5 | 59.4 | 58.2 |
,Placebo | 28.6 | 39.8 | 45.0 | 45.2 |
,Solifenacin 5 mg | 44.9 | 56.5 | 63.1 | 62.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 47.8 | 63.1 | 66.7 | 65.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.3 | 63.5 | 69.5 | 68.2 |
[back to top]
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 20.6 | 36.9 | 42.0 | 39.1 |
,Mirabegron 50 mg | 30.0 | 38.9 | 45.6 | 44.8 |
,Placebo | 15.2 | 24.9 | 33.3 | 33.3 |
,Solifenacin 5 mg | 28.6 | 43.0 | 49.9 | 49.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 32.7 | 46.3 | 54.5 | 51.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | 33.4 | 46.8 | 54.2 | 52.8 |
[back to top]
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT
The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 24.0 | 41.3 | 47.7 | 45.0 |
,Mirabegron 50 mg | 33.6 | 43.2 | 49.6 | 48.4 |
,Placebo | 17.8 | 29.7 | 35.8 | 36.1 |
,Solifenacin 5 mg | 31.4 | 47.8 | 54.5 | 53.3 |
,Solifenacin 5 mg + Mirabegron 25 mg | 37.5 | 51.6 | 58.2 | 56.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.2 | 54.7 | 62.0 | 60.3 |
[back to top]
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treaetment |
---|
Mirabegron 25 mg | 52.8 | 65.3 | 66.9 | 65.4 |
,Mirabegron 50 mg | 60.3 | 69.7 | 73.8 | 72.4 |
,Placebo | 48.9 | 56.4 | 59.8 | 59.8 |
,Solifenacin 5 mg | 58.1 | 72.7 | 74.1 | 71.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 63.1 | 71.6 | 76.6 | 75.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 62.7 | 75.4 | 80.0 | 78.4 |
[back to top]
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 52.8 | 62.2 | 62.4 | 61.0 |
,Mirabegron 50 mg | 59.7 | 65.3 | 69.1 | 68.3 |
,Placebo | 45.3 | 51.2 | 57.7 | 56.8 |
,Solifenacin 5 mg | 61.7 | 66.2 | 71.7 | 71.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 62.9 | 71.5 | 76.3 | 74.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 61.3 | 69.3 | 71.8 | 71.1 |
[back to top]
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 62.6 | 71.6 | 72.1 | 71.2 |
,Mirabegron 50 mg | 69.9 | 73.4 | 78.4 | 77.1 |
,Placebo | 56.4 | 62.2 | 66.0 | 65.3 |
,Solifenacin 5 mg | 73.9 | 79.2 | 82.4 | 81.2 |
,Solifenacin 5 mg + Mirabegron 25 mg | 73.9 | 83.9 | 83.5 | 82.8 |
,Solifenacin 5 mg + Mirabegron 50 mg | 75.8 | 82.8 | 85.1 | 84.3 |
[back to top]
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT
The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT). (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 45.3 | 61.8 | 66.4 | 64.5 |
,Mirabegron 50 mg | 56.7 | 63.7 | 70.2 | 69.0 |
,Placebo | 41.1 | 54.9 | 58.6 | 59.5 |
,Solifenacin 5 mg | 53.2 | 65.3 | 71.0 | 70.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 57.2 | 69.8 | 75.9 | 74.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 60.6 | 70.6 | 76.1 | 75.7 |
[back to top]
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT
The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 20.6 | 33.3 | 39.0 | 37.2 |
,Mirabegron 50 mg | 22.4 | 35.0 | 42.3 | 40.7 |
,Placebo | 15.9 | 27.0 | 29.6 | 29.5 |
,Solifenacin 5 mg | 27.4 | 40.5 | 44.5 | 42.6 |
,Solifenacin 5 mg + Mirabegron 25 mg | 31.1 | 42.7 | 50.7 | 49.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 31.1 | 46.4 | 52.9 | 51.2 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of particpants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 24.9 | 35.3 | 42.5 | 40.6 |
,Mirabegron 50 mg | 27.6 | 40.7 | 47.4 | 46.3 |
,Placebo | 23.2 | 28.7 | 38.0 | 37.6 |
,Solifenacin 5 mg | 28.9 | 38.3 | 42.7 | 42.9 |
,Solifenacin 5 mg + Mirabegron 25 mg | 35.1 | 45.3 | 52.3 | 50.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 37.3 | 48.2 | 52.7 | 52.2 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT
The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 13.1 | 24.4 | 32.2 | 30.6 |
,Mirabegron 50 mg | 16.7 | 29.8 | 35.0 | 34.0 |
,Placebo | 12.8 | 19.1 | 29.1 | 28.6 |
,Solifenacin 5 mg | 17.7 | 28.2 | 31.9 | 31.5 |
,Solifenacin 5 mg + Mirabegron 25 mg | 23.9 | 36.6 | 42.4 | 40.9 |
,Solifenacin 5 mg + Mirabegron 50 mg | 26.0 | 38.4 | 43.7 | 43.1 |
[back to top]
PGIC Scale: Impression in General Health at Week 12 and EoT
The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT01972841)
Timeframe: Week 12 and EoT (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Week 12: Very much improved | Week 12: Much improved | Week 12: Minimally improved | Week 12: No change | Week 12: Minimally worse | Week 12: Much worse | Week 12: Very much worse | End of treatment: Very much improved | End of treatment: Much improved | End of treatment: Minimally improved | End of treatment:No change | End of treatment: Minimally worse | End of treatment: Much worse | End of treatment: Very much worse |
---|
Mirabegron 25 mg | 8.0 | 28.0 | 21.5 | 27.8 | 2.9 | 0.7 | 0.5 | 8.0 | 28.0 | 21.5 | 28.3 | 2.9 | 0.7 | 0.7 |
,Mirabegron 50 mg | 7.3 | 29.2 | 22.4 | 27.5 | 2.2 | 1.2 | 0.5 | 7.3 | 29.2 | 22.9 | 27.7 | 2.4 | 1.2 | 0.5 |
,Placebo | 4.8 | 23.9 | 23.9 | 31.8 | 4.3 | 1.7 | 0.2 | 4.8 | 24.2 | 24.4 | 32.3 | 4.3 | 1.9 | 0.5 |
,Solifenacin 5 mg | 7.7 | 31.8 | 24.1 | 25.3 | 1.4 | 0.5 | 0.5 | 7.7 | 31.8 | 24.1 | 26.5 | 1.9 | 0.5 | 0.7 |
,Solifenacin 5 mg + Mirabegron 25 mg | 10.3 | 33.4 | 20.1 | 23.9 | 2.5 | 0.5 | 0.2 | 10.3 | 33.6 | 20.2 | 24.3 | 2.8 | 0.5 | 0.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 14.6 | 30.2 | 20.9 | 21.6 | 2.2 | 0.1 | 0.6 | 14.6 | 30.4 | 21.3 | 21.9 | 2.7 | 0.2 | 0.7 |
[back to top]
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period. (NCT01972841)
Timeframe: Weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 15.65 | 12.84 | 10.60 | 11.19 |
,Mirabegron 50 mg | 12.90 | 11.31 | 9.50 | 9.79 |
,Placebo | 18.09 | 14.45 | 14.06 | 13.70 |
,Solifenacin 5 mg | 15.31 | 12.19 | 11.25 | 11.21 |
,Solifenacin 5 mg + Mirabegron 25 mg | 12.51 | 9.70 | 7.62 | 8.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | 11.44 | 9.33 | 8.21 | 8.18 |
[back to top]
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day. (NCT01972841)
Timeframe: Weeks 4, 8,12 and EoT (up to 12 weeks)
Intervention | days (Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 1.74 | 2.08 | 2.31 | 2.28 |
,Mirabegron 50 mg | 1.55 | 1.99 | 2.25 | 2.22 |
,Placebo | 1.49 | 1.69 | 1.76 | 1.80 |
,Solifenacin 5 mg | 1.86 | 2.22 | 2.49 | 2.49 |
,Solifenacin 5 mg + Mirabegron 25 mg | 2.07 | 2.59 | 2.87 | 2.84 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.11 | 2.70 | 2.95 | 2.92 |
[back to top]
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | incontinence episodes (Least Squares Mean) |
---|
Placebo | -1.34 |
Mirabegron 25 mg | -1.70 |
Mirabegron 50 mg | -1.76 |
Solifenacin 5 mg | -1.79 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.04 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.98 |
[back to top]
Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. (NCT01972841)
Timeframe: Baseline and Week 12
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | 0.15 |
Mirabegron 25 mg | -0.17 |
Mirabegron 50 mg | -0.97 |
Solifenacin 5 mg | -1.28 |
Solifenacin 5 mg + Mirabegron 25 mg | -1.10 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.52 |
[back to top]
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | micturitions (Least Squares Mean) |
---|
Placebo | -1.64 |
Mirabegron 25 mg | -2.00 |
Mirabegron 50 mg | -2.03 |
Solifenacin 5 mg | -2.20 |
Solifenacin 5 mg + Mirabegron 25 mg | -2.49 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.59 |
[back to top]
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | mL (Least Squares Mean) |
---|
Placebo | 8.44 |
Mirabegron 25 mg | 13.32 |
Mirabegron 50 mg | 21.99 |
Solifenacin 5 mg | 30.99 |
Solifenacin 5 mg + Mirabegron 25 mg | 34.84 |
Solifenacin 5 mg + Mirabegron 50 mg | 39.73 |
[back to top]
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -19.45 |
Mirabegron 25 mg | -23.93 |
Mirabegron 50 mg | -26.14 |
Solifenacin 5 mg | -26.44 |
Solifenacin 5 mg + Mirabegron 25 mg | -31.06 |
Solifenacin 5 mg + Mirabegron 50 mg | -32.24 |
[back to top]
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 1.42 |
Mirabegron 25 mg | 2.16 |
Mirabegron 50 mg | 2.18 |
Solifenacin 5 mg | 2.28 |
Solifenacin 5 mg + Mirabegron 25 mg | 2.53 |
Solifenacin 5 mg + Mirabegron 50 mg | 2.55 |
[back to top]
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| Not anxious -> not anxious | Not anxious -> slightly anxious | Not anxious -> moderately anxious | Not anxious -> severely anxious | Not anxious -> extremely anxious | Not anxious -> no data | Slightly anxious -> not anxious | Slightly anxious -> slightly anx | Slightly anxious -> moderately anxious | Slightly anxious -> severely anxious | Slightly anxious -> extremely anxious | Slightly anxious -> no data | Moderately anxious -> not anxious | Moderately anxious -> slightly anxious | Moderately anxious -> moderately anxious | Moderately anxious -> severely anxious | Moderately anxious -> extremely anxious | Moderately anxious -> no data | Severely anxious -> not anxious | Severely anxious -> slightly anxious | Severely anxious -> moderately anxious | Severely anxious -> severely anxious | Severely anxious -> extremely anxious | Severely anxious -> no data | Extremely anxious -> not anxious | Extremely anxious -> slightly anxious | Extremely anxious -> moderately anxious | Extremely anxious -> severely anxious | Extremely anxious -> extremely anxious | Extremely anxious -> no data | No data -> not anxious | No data -> slightly anxious | No data -> moderately anxious | No data -> severely anxious | No data -> extremely anxious | No data -> no data |
---|
Mirabegron 25 mg | 176 | 27 | 6 | 2 | 0 | 3 | 60 | 40 | 16 | 2 | 0 | 3 | 13 | 17 | 7 | 3 | 1 | 1 | 5 | 3 | 7 | 1 | 0 | 1 | 1 | 2 | 1 | 1 | 0 | 0 | 8 | 1 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 187 | 25 | 6 | 5 | 1 | 2 | 54 | 45 | 12 | 2 | 0 | 2 | 12 | 19 | 11 | 0 | 0 | 2 | 6 | 4 | 2 | 2 | 0 | 1 | 0 | 1 | 1 | 1 | 2 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 157 | 42 | 7 | 0 | 0 | 2 | 42 | 49 | 17 | 4 | 0 | 2 | 12 | 19 | 17 | 2 | 0 | 1 | 7 | 3 | 5 | 10 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 9 | 4 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 166 | 29 | 8 | 1 | 0 | 1 | 59 | 40 | 17 | 2 | 0 | 5 | 22 | 14 | 10 | 1 | 0 | 0 | 6 | 5 | 6 | 5 | 1 | 0 | 0 | 2 | 1 | 3 | 1 | 0 | 6 | 2 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 360 | 45 | 13 | 2 | 0 | 3 | 122 | 79 | 18 | 5 | 1 | 3 | 42 | 43 | 18 | 8 | 1 | 1 | 12 | 11 | 6 | 5 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 0 | 13 | 6 | 1 | 0 | 1 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 370 | 50 | 11 | 1 | 1 | 6 | 134 | 65 | 16 | 5 | 0 | 4 | 35 | 41 | 23 | 7 | 1 | 3 | 8 | 6 | 7 | 2 | 3 | 0 | 1 | 3 | 1 | 1 | 2 | 0 | 14 | 3 | 2 | 1 | 0 | 0 |
[back to top]
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No pain/discomfort -> no pain/discomfort | No pain/discomfort -> slight pain/discomfort | No pain/discomfort -> moderate pain/discomfort | No pain/discomfort -> severe pain/discomfort | No pain/discomfort -> extreme pain/discomfort | No pain/discomfort -> no data | Slight pain/discomfort -> no pain/discomfort | Slight pain/discomfort -> slight pain/discomfort | Slight pain/discomfort -> moderate pain/discomfort | Slight pain/discomfort -> severe pain/discomfort | Slight pain/discomfort -> exteme pain/discomfort | Slight pain/discomfort -> no data | Moderate pain/discomfort -> no pain/discomfort | Moderate pain/discomfort -> slight pain/discomfort | Moderate pain/discomfort -> moderate pain/discomf | Moderate pain/discomfort -> severe pain/discomfort | Moderate pain/discomfort -> extreme pain/discomf | Moderate pain/discomfort -> no data | Severe pain/discomfort -> no pain/discomfort | Severe pain/discomfort -> slight pain/discomfort | Severe pain/discomfort -> moderate pain/discomfort | Severe pain/discomfort -> severe pain/discomfort | Severe pain/discomfort -> extreme pain/discomfort | Severe pain/discomfort -> no data | Extreme pain/discomfort -> no pain/discomfort | Extreme pain/discomfort -> slight pain/discomfort | Extreme pain/discomfort -> moderate pain/discom. | Extreme pain/discomfort -> severe pain/discomfort | Extreme pain/discomfort -> extreme pain/discomfort | Extreme pain/discomfort -> no data | No data -> no pain/discomfort | No data -> slight pain/discomfort | No data -> moderate pain/discomfort | No data -> severe pain/discomfort | No data -> extreme pain/discomfort | No data -> no data |
---|
Mirabegron 25 mg | 175 | 29 | 9 | 0 | 0 | 3 | 51 | 49 | 11 | 0 | 0 | 5 | 14 | 15 | 13 | 5 | 0 | 0 | 4 | 4 | 4 | 3 | 1 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 5 | 2 | 4 | 0 | 0 | 0 |
,Mirabegron 50 mg | 153 | 37 | 17 | 3 | 0 | 4 | 44 | 45 | 14 | 2 | 1 | 2 | 24 | 20 | 16 | 3 | 0 | 0 | 3 | 6 | 6 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 131 | 38 | 10 | 0 | 0 | 2 | 53 | 54 | 12 | 3 | 2 | 2 | 20 | 23 | 31 | 4 | 0 | 1 | 2 | 3 | 8 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 11 | 2 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 154 | 33 | 13 | 3 | 0 | 2 | 46 | 47 | 18 | 0 | 0 | 2 | 23 | 22 | 15 | 1 | 0 | 1 | 1 | 4 | 11 | 4 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 6 | 2 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 290 | 74 | 19 | 3 | 1 | 3 | 117 | 94 | 15 | 6 | 0 | 2 | 45 | 46 | 34 | 4 | 1 | 1 | 8 | 11 | 15 | 7 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 0 | 14 | 6 | 1 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 317 | 51 | 20 | 1 | 0 | 8 | 105 | 101 | 19 | 3 | 0 | 4 | 46 | 45 | 40 | 6 | 0 | 1 | 12 | 7 | 11 | 8 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 14 | 3 | 3 | 0 | 0 | 0 |
[back to top]
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> unable to wash/dress myself | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> unable to wash/dress myself | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> unable to wash/dress myself | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to wash/dress myself | Severe problems -> no data | Unable to wash/dress myself -> no problems | Unable to wash/dress myself -> slight problems | Unable to wash/dress myself -> moderate problems | Unable to wash/dress myself -> severe problems | Unable to wash/dress myself -> unable to w/d | Unable to wash/dress myself -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to wash/dress myself | No data -> no data |
---|
Mirabegron 25 mg | 324 | 17 | 5 | 0 | 0 | 8 | 13 | 10 | 4 | 0 | 0 | 0 | 8 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 8 | 2 | 1 | 0 | 0 | 0 |
,Mirabegron 50 mg | 336 | 9 | 6 | 1 | 1 | 6 | 16 | 12 | 1 | 0 | 0 | 0 | 3 | 8 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 1 |
,Placebo | 311 | 21 | 9 | 0 | 1 | 4 | 17 | 10 | 2 | 2 | 0 | 1 | 6 | 3 | 9 | 0 | 0 | 0 | 2 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 319 | 20 | 3 | 1 | 0 | 5 | 25 | 12 | 2 | 0 | 0 | 1 | 2 | 3 | 6 | 0 | 0 | 0 | 1 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 8 | 1 | 1 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 652 | 22 | 12 | 1 | 0 | 6 | 35 | 22 | 3 | 1 | 0 | 1 | 17 | 9 | 8 | 2 | 0 | 0 | 3 | 3 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 647 | 26 | 4 | 1 | 0 | 12 | 33 | 26 | 7 | 2 | 0 | 0 | 18 | 7 | 9 | 1 | 0 | 1 | 4 | 3 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 18 | 0 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> No problems | No problems -> Slight problems | No problems -> Moderate problems | No problems -> Severe problems | No problems -> unable to do usual activities | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems ->unable to do usual activities | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems ->unable to do usual activities | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to do usual activities | Severe problems -> no data | Unable to do usual activities -> no problems | Unable to do usual activities -> slight problems | Unable to do usual activities -> moderate problems | Unable to do usual activities -> severe problems | Unable to do usual activities -> unable to do usu. | Unable to do usual activities -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to do usual activities | No data -> no data |
---|
Mirabegron 25 mg | 228 | 25 | 5 | 0 | 0 | 5 | 41 | 29 | 9 | 0 | 0 | 2 | 13 | 9 | 11 | 3 | 0 | 1 | 3 | 4 | 7 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 7 | 2 | 2 | 0 | 0 | 0 |
,Mirabegron 50 mg | 219 | 28 | 9 | 1 | 0 | 4 | 52 | 23 | 3 | 2 | 0 | 0 | 15 | 16 | 9 | 0 | 0 | 2 | 7 | 6 | 5 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 |
,Placebo | 196 | 37 | 9 | 2 | 0 | 2 | 45 | 28 | 15 | 2 | 0 | 2 | 14 | 12 | 15 | 1 | 0 | 1 | 7 | 3 | 6 | 4 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 223 | 25 | 8 | 0 | 0 | 3 | 52 | 25 | 8 | 0 | 0 | 3 | 13 | 14 | 12 | 1 | 0 | 0 | 6 | 2 | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 1 | 2 | 0 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 434 | 37 | 13 | 1 | 1 | 5 | 98 | 64 | 18 | 2 | 0 | 2 | 44 | 29 | 25 | 3 | 0 | 0 | 7 | 8 | 9 | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 18 | 1 | 2 | 0 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 451 | 48 | 11 | 1 | 1 | 8 | 95 | 56 | 12 | 3 | 0 | 4 | 26 | 30 | 17 | 3 | 1 | 1 | 11 | 8 | 7 | 9 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 15 | 3 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). (NCT01972841)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | participants (Number) |
---|
| No problems -> no problems | No problems -> slight problems | No problems -> moderate problems | No problems -> severe problems | No problems -> unable to walk about | No problems -> no data | Slight problems -> no problems | Slight problems -> slight problems | Slight problems -> moderate problems | Slight problems -> severe problems | Slight problems -> unable to walk about | Slight problems -> no data | Moderate problems -> no problems | Moderate problems -> slight problems | Moderate problems -> moderate problems | Moderate problems -> severe problems | Moderate problems -> unable to walk about | Moderate problems -> no data | Severe problems -> no problems | Severe problems -> slight problems | Severe problems -> moderate problems | Severe problems -> severe problems | Severe problems -> unable to walk about | Severe problems -> no data | Unable to walk about -> no problems | Unable to walk about -> slight problems | Unable to walk about -> moderate problems | Unable to walk about -> severe problems | Unable to walk about -> unable to walk about | Unable to walk about -> no data | No data -> no problems | No data -> slight problems | No data -> moderate problems | No data -> severe problems | No data -> unable to walk about | No data -> no data |
---|
Mirabegron 25 mg | 239 | 20 | 12 | 3 | 1 | 4 | 35 | 20 | 6 | 0 | 0 | 3 | 7 | 10 | 12 | 5 | 0 | 1 | 5 | 7 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 3 | 1 | 0 | 0 |
,Mirabegron 50 mg | 225 | 25 | 9 | 3 | 0 | 5 | 35 | 24 | 4 | 3 | 0 | 0 | 25 | 10 | 10 | 4 | 0 | 0 | 9 | 3 | 8 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 0 | 0 | 1 |
,Placebo | 204 | 16 | 11 | 1 | 0 | 2 | 33 | 27 | 11 | 5 | 0 | 2 | 17 | 18 | 21 | 10 | 0 | 1 | 3 | 6 | 5 | 8 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 12 | 1 | 0 | 0 | 0 | 1 |
,Solifenacin 5 mg | 227 | 22 | 8 | 1 | 0 | 4 | 30 | 19 | 6 | 1 | 0 | 0 | 18 | 22 | 13 | 2 | 1 | 1 | 7 | 4 | 8 | 8 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 2 | 0 | 0 |
,Solifenacin 5 mg + Mirabegron 25 mg | 449 | 41 | 20 | 1 | 0 | 6 | 76 | 40 | 19 | 2 | 0 | 0 | 31 | 24 | 33 | 8 | 1 | 0 | 12 | 13 | 15 | 11 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 15 | 4 | 0 | 2 | 0 | 1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 452 | 38 | 10 | 2 | 1 | 9 | 60 | 49 | 9 | 2 | 0 | 2 | 46 | 25 | 35 | 10 | 1 | 2 | 17 | 8 | 15 | 13 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 16 | 2 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT01972841)
Timeframe: Baseline and week 12 and EoT (up to 12 weeks)
Intervention | percentage of work time missed (Mean) |
---|
| Week 12 | End of treatment |
---|
Mirabegron 25 mg | -0.33 | -0.33 |
,Mirabegron 50 mg | -1.72 | -1.71 |
,Placebo | -2.98 | -2.96 |
,Solifenacin 5 mg | -2.47 | -2.44 |
,Solifenacin 5 mg + Mirabegron 25 mg | -2.06 | -1.48 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.59 | -2.55 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping
The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT01972841)
Timeframe: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | End of treatment |
---|
Mirabegron 25 mg | 14.87 | 20.64 | 22.04 | 21.28 |
,Mirabegron 50 mg | 17.68 | 21.52 | 24.94 | 24.32 |
,Placebo | 11.74 | 16.13 | 18.17 | 17.73 |
,Solifenacin 5 mg | 16.52 | 21.69 | 23.67 | 23.25 |
,Solifenacin 5 mg + Mirabegron 25 mg | 19.31 | 25.49 | 28.32 | 27.37 |
,Solifenacin 5 mg + Mirabegron 50 mg | 20.36 | 25.85 | 29.03 | 28.12 |
[back to top]
Bladder Capacity
Urodynamic bladder capacity (NCT02044510)
Timeframe: 10 weeks
Intervention | mL (Least Squares Mean) |
---|
Mirabegron | 305 |
Placebo | 369 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.67 | -1.12 | -1.30 | -1.38 | -1.35 | -1.23 |
,Solifenacin 5 mg | -0.96 | -1.30 | -1.24 | -1.31 | -1.37 | -1.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.25 | -1.49 | -1.59 | -1.65 | -1.67 | -1.66 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
"A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit." (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.20 | -0.34 | -0.41 | -0.42 | -0.46 | -0.45 |
,Solifenacin 5 mg | -0.22 | -0.38 | -0.39 | -0.44 | -0.44 | -0.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -0.34 | -0.46 | -0.49 | -0.50 | -0.56 | -0.55 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 10.96 | 14.09 | 14.84 | 14.86 | 16.53 | 16.44 |
,Solifenacin 5 mg | 14.24 | 16.71 | 17.70 | 17.73 | 18.28 | 18.32 |
,Solifenacin 5 mg + Mirabegron 50 mg | 15.82 | 19.75 | 20.09 | 21.15 | 22.17 | 21.59 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.05 | 17.57 | 19.68 | 19.54 | 19.47 | 18.54 |
,Solifenacin 5 mg | 15.40 | 18.38 | 20.53 | 21.21 | 21.90 | 21.13 |
,Solifenacin 5 mg + Mirabegron 50 mg | 17.58 | 21.64 | 22.73 | 23.58 | 24.86 | 24.14 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.24 | 16.37 | 17.77 | 18.15 | 19.10 | 17.98 |
,Solifenacin 5 mg | 15.49 | 17.64 | 19.05 | 19.74 | 19.40 | 19.22 |
,Solifenacin 5 mg + Mirabegron 50 mg | 17.60 | 21.23 | 21.73 | 22.30 | 23.30 | 23.00 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 7.99 | 11.14 | 11.89 | 11.92 | 12.25 | 11.57 |
,Solifenacin 5 mg | 9.41 | 11.19 | 12.54 | 13.33 | 13.47 | 13.22 |
,Solifenacin 5 mg + Mirabegron 50 mg | 9.89 | 12.22 | 13.30 | 13.64 | 14.52 | 14.25 |
[back to top]
[back to top]
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 17.2 | 27.0 | 32.3 | 37.1 | 41.9 | 38.9 |
,Solifenacin 5 mg | 26.4 | 35.1 | 39.9 | 43.7 | 47.3 | 45.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 27.9 | 40.0 | 44.7 | 46.9 | 52.5 | 49.7 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 24.4 | 40.1 | 40.6 | 47.0 | 51.6 | 47.8 |
,Solifenacin 5 mg | 39.9 | 44.8 | 50.5 | 54.4 | 55.5 | 53.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 38.3 | 49.6 | 54.7 | 55.8 | 61.2 | 58.8 |
[back to top]
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 34.5 | 36.7 | 42.3 | 44.5 | 46.3 | 46.0 |
,Solifenacin 5 mg | 29.3 | 36.6 | 43.4 | 41.9 | 44.7 | 46.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 36.8 | 46.6 | 51.4 | 52.5 | 56.4 | 55.9 |
[back to top]
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 24.9 | 31.3 | 35.0 | 37.5 | 40.6 | 38.3 |
,Solifenacin 5 mg | 28.2 | 33.9 | 38.2 | 40.9 | 40.4 | 39.8 |
,Solifenacin 5 mg + Mirabegron 50 mg | 30.7 | 42.8 | 45.4 | 47.0 | 51.9 | 50.3 |
[back to top]
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 46.7 | 58.2 | 63.2 | 67.0 | 72.9 | 69.1 |
,Solifenacin 5 mg | 55.2 | 67.0 | 71.8 | 73.6 | 75.4 | 73.1 |
,Solifenacin 5 mg + Mirabegron 50 mg | 62.0 | 73.3 | 76.6 | 77.8 | 81.3 | 79.5 |
[back to top]
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 63.7 | 69.1 | 70.4 | 70.1 | 72.8 | 70.7 |
,Solifenacin 5 mg | 67.5 | 71.3 | 74.6 | 76.1 | 74.1 | 72.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 72.8 | 81.8 | 80.5 | 82.9 | 84.4 | 82.9 |
[back to top]
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 46.6 | 53.6 | 56.9 | 57.1 | 58.4 | 56.2 |
,Solifenacin 5 mg | 53.8 | 59.4 | 62.9 | 62.9 | 62.4 | 61.6 |
,Solifenacin 5 mg + Mirabegron 50 mg | 57.0 | 64.6 | 66.1 | 67.7 | 69.0 | 68.4 |
[back to top]
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 53.0 | 61.9 | 64.6 | 65.5 | 69.7 | 66.2 |
,Solifenacin 5 mg | 59.2 | 65.7 | 68.8 | 68.9 | 73.7 | 71.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 64.1 | 72.5 | 73.8 | 75.1 | 76.9 | 76.0 |
[back to top]
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 29.9 | 38.9 | 42.4 | 46.5 | 51.4 | 47.4 |
,Solifenacin 5 mg | 35.5 | 44.8 | 46.1 | 50.8 | 53.6 | 51.4 |
,Solifenacin 5 mg + Mirabegron 50 mg | 42.8 | 54.1 | 55.9 | 59.2 | 63.7 | 61.7 |
[back to top]
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 36.1 | 47.8 | 50.4 | 53.1 | 59.2 | 55.7 |
,Solifenacin 5 mg | 46.6 | 55.5 | 56.9 | 61.9 | 60.9 | 58.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 52.6 | 65.1 | 65.8 | 69.2 | 73.2 | 70.8 |
[back to top]
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 28.5 | 39.6 | 41.6 | 43.7 | 46.9 | 44.3 |
,Solifenacin 5 mg | 36.6 | 43.8 | 47.9 | 51.2 | 50.4 | 49.0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 40.9 | 52.3 | 55.3 | 57.6 | 60.6 | 59.2 |
[back to top]
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 32.1 | 43.3 | 46.8 | 49.6 | 57.6 | 52.9 |
,Solifenacin 5 mg | 37.1 | 47.7 | 52.1 | 53.2 | 60.1 | 57.5 |
,Solifenacin 5 mg + Mirabegron 50 mg | 46.0 | 57.6 | 60.6 | 63.0 | 67.0 | 65.1 |
[back to top]
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12
Intervention | percentage of participants (Number) |
---|
| Month 12: Very much improved | Month 12: Much improved | Month 12: Minimally improved | Month 12: No change | Month 12: Minimally worse | Month 12: Much worse | Month 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 50 mg | 12.9 | 23.8 | 18.9 | 24.2 | 3.6 | 0.7 | 0.7 | 13.2 | 24.5 | 19.2 | 25.8 | 3.6 | 1.0 | 0.7 |
,Solifenacin 5 mg | 14.7 | 26.8 | 17.1 | 24.7 | 2.7 | 0 | 0.7 | 15.1 | 27.8 | 18.1 | 25.8 | 3.0 | 0.3 | 0.7 |
,Solifenacin 5 mg + Mirabegron 50 mg | 18.0 | 28.7 | 18.7 | 20.7 | 2.7 | 0.4 | 0.3 | 18.3 | 28.9 | 19.1 | 21.6 | 2.8 | 0.5 | 0.3 |
[back to top]
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). (NCT02045862)
Timeframe: Month 12
Intervention | percentage of participants (Number) |
---|
| Month 12: Very much improved | Month 12: Much improved | Month 12: Minimally improved | Month 12: No change | Month 12: Minimally worse | Month 12: Much worse | Month 12: Very much worse | EoT: Very much improved | EoT: Much improved | EoT: Minimally improved | EoT: No change | EoT: Minimally worse | EoT: Much worse | EoT: Very much worse |
---|
Mirabegron 50 mg | 25.5 | 30.5 | 21.9 | 5.0 | 0.7 | 1.0 | 0.3 | 25.8 | 31.5 | 22.2 | 6.3 | 0.7 | 1.3 | 0.3 |
,Solifenacin 5 mg | 23.4 | 35.8 | 19.7 | 6.4 | 0.7 | 0.3 | 0.3 | 24.4 | 37.1 | 20.4 | 7.0 | 0.7 | 0.7 | 0.3 |
,Solifenacin 5 mg + Mirabegron 50 mg | 33.8 | 34.0 | 16.1 | 4.5 | 0.4 | 0.1 | 0.5 | 34.1 | 34.7 | 16.6 | 5.1 | 0.4 | 0.1 | 0.5 |
[back to top]
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | percentage of participants (Number) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 25.2 | 33.3 | 36.8 | 39.0 | 44.1 | 40.1 |
,Solifenacin 5 mg | 29.0 | 39.1 | 41.2 | 44.0 | 47.6 | 45.2 |
,Solifenacin 5 mg + Mirabegron 50 mg | 35.5 | 45.9 | 49.6 | 51.3 | 54.6 | 53.3 |
[back to top]
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 13.14 | 10.37 | 8.97 | 8.08 | 7.73 | 8.86 |
,Solifenacin 5 mg | 11.21 | 8.12 | 7.31 | 6.51 | 6.06 | 7.04 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.99 | 6.95 | 5.88 | 5.47 | 4.88 | 5.57 |
[back to top]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities). (NCT02045862)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild TEAEs | Moderate TEAEs | Severe TEAEs | Drug-related TEAEs | Serious TEAEs | Drug-related Serious TEAEs | TEAEs Leading to Discontuation of Study Drug | Drug-related TEAEs Leading to Discont. of Drug | TEAEs Leading to Death |
---|
Mirabegron 50 mg | 126 | 61 | 52 | 13 | 35 | 8 | 1 | 7 | 4 | 0 |
,Solifenacin 5 mg | 134 | 69 | 58 | 7 | 42 | 8 | 0 | 5 | 4 | 0 |
,Solifenacin 5 mg + Mirabegron 50 mg | 596 | 306 | 238 | 52 | 200 | 51 | 0 | 25 | 17 | 1 |
[back to top]
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | pads (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 12.67 | 9.61 | 7.99 | 7.65 | 7.60 | 9.09 |
,Solifenacin 5 mg | 12.55 | 9.47 | 9.16 | 8.91 | 8.09 | 8.54 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.75 | 7.23 | 6.51 | 6.18 | 5.70 | 6.33 |
[back to top]
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 8.76 | 7.93 | 7.12 | 7.40 | 6.88 | 7.13 |
,Solifenacin 5 mg | 9.23 | 7.92 | 7.86 | 7.48 | 7.39 | 7.47 |
,Solifenacin 5 mg + Mirabegron 50 mg | 8.00 | 7.17 | 6.96 | 6.84 | 6.33 | 6.51 |
[back to top]
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 1.03 | 1.24 | 1.56 | 1.56 | 1.87 | 1.75 |
,Solifenacin 5 mg | 1.01 | 1.48 | 1.66 | 1.64 | 1.92 | 1.90 |
,Solifenacin 5 mg + Mirabegron 50 mg | 1.33 | 1.91 | 2.13 | 2.20 | 2.54 | 2.43 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | 1.88 | 2.10 | 2.22 | 2.24 | 2.33 |
,Solifenacin 5 mg | 1.95 | 2.06 | 2.25 | 2.28 | 2.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.27 | 2.57 | 2.72 | 2.74 | 2.89 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -16.37 | -19.69 | -20.97 | -21.41 | -23.41 |
,Solifenacin 5 mg | -20.82 | -23.13 | -24.27 | -25.82 | -25.38 |
,Solifenacin 5 mg + Mirabegron 50 mg | -22.86 | -26.88 | -27.73 | -28.45 | -30.18 |
[back to top]
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | incontinence-free days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 2.73 | 3.30 | 3.64 | 3.97 | 4.23 | 3.98 |
,Solifenacin 5 mg | 3.35 | 3.98 | 4.08 | 4.33 | 4.5 | 4.29 |
,Solifenacin 5 mg + Mirabegron 50 mg | 3.46 | 4.17 | 4.44 | 4.56 | 4.81 | 4.64 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | micturitions (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -1.09 | -1.63 | -1.85 | -2.03 | -2.20 |
,Solifenacin 5 mg | -1.36 | -1.87 | -2.04 | -2.03 | -2.13 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.64 | 2.16 | -2.39 | -2.42 | -2.64 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
---|
Mirabegron 50 mg | -0.97 | -1.31 | -1.42 | -1.53 | -1.67 |
,Solifenacin 5 mg | -1.29 | -1.71 | -1.78 | -1.90 | -1.92 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.45 | -1.78 | -1.93 | -2.00 | -2.06 |
[back to top]
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Least Squares Mean) |
---|
Mirabegron 50 mg | 2.19 |
Solifenacin 5 mg | 2.15 |
Solifenacin 5 mg + Mirabegron 50 mg | 2.73 |
[back to top]
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | units on a scale (Least Squares Mean) |
---|
Mirabegron 50 mg | -21.96 |
Solifenacin 5 mg | -24.91 |
Solifenacin 5 mg + Mirabegron 50 mg | -29.51 |
[back to top]
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | mL (Least Squares Mean) |
---|
Mirabegron 50 mg | 21.83 |
Solifenacin 5 mg | 24.90 |
Solifenacin 5 mg + Mirabegron 50 mg | 37.67 |
[back to top]
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -2.10 |
Solifenacin 5 mg | -2.16 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.58 |
[back to top]
Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT. (NCT02045862)
Timeframe: Baseline and Month 12
Intervention | micturitions (Least Squares Mean) |
---|
Mirabegron 50 mg | -0.72 |
Solifenacin 5 mg | -1.11 |
Solifenacin 5 mg + Mirabegron 50 mg | -1.51 |
[back to top]
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits. (NCT02045862)
Timeframe: Baseline and Week 52
Intervention | incontinence episodes (Least Squares Mean) |
---|
Mirabegron 50 mg | -1.58 |
Solifenacin 5 mg | -1.90 |
Solifenacin 5 mg + Mirabegron 50 mg | -2.03 |
[back to top]
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 14.88 | 12.23 | 10.62 | 10.53 | 9.09 | 10.32 |
,Solifenacin 5 mg | 12.41 | 9.23 | 8.18 | 7.28 | 7.06 | 8.09 |
,Solifenacin 5 mg + Mirabegron 50 mg | 10.80 | 8.33 | 7.28 | 6.74 | 6.10 | 6.85 |
[back to top]
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day. (NCT02045862)
Timeframe: Months 1, 3, 6, 9, 12
Intervention | days (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 1.90 | 2.07 | 2.35 | 2.38 | 2.61 | 2.52 |
,Solifenacin 5 mg | 1.60 | 2.14 | 2.34 | 2.33 | 2.58 | 2.58 |
,Solifenacin 5 mg + Mirabegron 50 mg | 2.08 | 2.66 | 2.87 | 2.93 | 3.17 | 3.10 |
[back to top]
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of overall work impairment (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -16.33 | -17.83 | -16.83 |
,Solifenacin 5 mg | -12.09 | -15.38 | -14.16 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.99 | -17.27 | -16.15 |
[back to top]
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of activity Impairment (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -15.04 | -16.85 | -16.02 |
,Solifenacin 5 mg | -16.25 | -14.12 | -14.02 |
,Solifenacin 5 mg + Mirabegron 50 mg | -16.94 | -18.91 | -18.75 |
[back to top]
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6, 12
Intervention | percentage of impairment while working (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -16.94 | -19.16 | -17.81 |
,Solifenacin 5 mg | -12.97 | -14.72 | -13.90 |
,Solifenacin 5 mg + Mirabegron 50 mg | -13.41 | -16.68 | -15.63 |
[back to top]
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. (NCT02045862)
Timeframe: Baseline and Months 6,12
Intervention | percentage of work time missed (Mean) |
---|
| Month 6 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.49 | 0.39 | -0.45 |
,Solifenacin 5 mg | -0.59 | -1.95 | -1.30 |
,Solifenacin 5 mg + Mirabegron 50 mg | -3.11 | -3.74 | -3.26 |
[back to top]
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 3, 6, 12
Intervention | mL (Least Squares Mean) |
---|
| Month 3 | Month 6 | Month 12 |
---|
Mirabegron 50 mg | 15.34 | 20.87 | 21.85 |
,Solifenacin 5 mg | 23.71 | 27.08 | 24.05 |
,Solifenacin 5 mg + Mirabegron 50 mg | 34.89 | 38.56 | 38.72 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | mL (Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | 3.179 | 4.686 | 1.596 | 3.074 | 2.002 | 1.747 |
,Solifenacin 5 mg | 4.549 | 3.233 | 3.418 | 3.436 | 4.818 | 7.382 |
,Solifenacin 5 mg + Mirabegron 50 mg | 7.894 | 7.033 | 6.708 | 8.229 | 7.946 | 8.522 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.84 | -1.09 | -1.11 | -1.25 | -1.29 | -1.22 |
,Solifenacin 5 mg | -0.89 | -1.08 | -1.18 | -1.31 | -1.36 | -1.34 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.05 | -1.33 | -1.42 | -1.48 | -1.59 | -1.54 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -6.45 | -9.06 | -10.09 | -11.1 | -11.27 | -10.61 |
,Solifenacin 5 mg | -8.77 | -11.48 | -11.71 | -12.6 | -12.8 | 12.66 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.1 | -11.99 | -13.0 | -13.44 | -13.8 | -13.59 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | pads (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -4.74 | -7.83 | -9.09 | -9.59 | -9.39 | -8.59 |
,Solifenacin 5 mg | -6.72 | -9.21 | -8.86 | -9.33 | -9.92 | -9.89 |
,Solifenacin 5 mg + Mirabegron 50 mg | -8.89 | 10.47 | -11.12 | -11.44 | -11.66 | -11.58 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | nocturia episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -1.56 | -2.45 | -3.08 | -2.91 | -3.29 | -3.24 |
,Solifenacin 5 mg | -1.58 | -2.78 | -2.81 | -3.13 | -3.08 | -3.20 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.39 | -3.26 | -3.44 | -3.55 | -3.97 | -3.90 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -6.77 | -9.21 | -10.36 | -10.62 | -11.84 | -11.17 |
,Solifenacin 5 mg | -9.17 | -12.05 | -12.50 | -13.51 | -13.47 | -13.37 |
,Solifenacin 5 mg + Mirabegron 50 mg | -10.31 | -12.55 | -13.49 | -14.06 | -14.43 | -14.29 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency incontinence episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -0.93 | -1.30 | -1.40 | -1.60 | -1.60 | -1.51 |
,Solifenacin 5 mg | -1.25 | -1.64 | -1.67 | -1.78 | -1.82 | -1.81 |
,Solifenacin 5 mg + Mirabegron 50 mg | -1.43 | -1.71 | -1.86 | -1.92 | -1.98 | -1.94 |
[back to top]
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. (NCT02045862)
Timeframe: Baseline and Months 1, 3, 6, 9, 12
Intervention | urgency episodes (Least Squares Mean) |
---|
| Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | EoT |
---|
Mirabegron 50 mg | -1.93 | -2.68 | -2.93 | -3.40 | -3.40 | -3.11 |
,Solifenacin 5 mg | -2.31 | -3.02 | -3.17 | -3.55 | -3.56 | -3.45 |
,Solifenacin 5 mg + Mirabegron 50 mg | -2.68 | -3.36 | -3.72 | -3.87 | -3.95 | -3.84 |
[back to top]
Mean # of Incontinence Episodes/Day
"Secondary Outcome Measure based on voiding diary:~Baseline vs. Final Visit: Mean # of incontinence episodes/day" (NCT02086188)
Timeframe: 10 weeks
Intervention | Incontinence Episodes/Day (Mean) |
---|
Mirabegron | 0.7 |
Placebo | 1.05 |
[back to top]
Subject Global Impression (Single Question)
"Secondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: How would you rate your level of bladder control during the past week? 1-7 analog scale, 1 = terrible' 7 = delighted." (NCT02086188)
Timeframe: 10 weeks
Intervention | score on a scale (Mean) |
---|
Mirabegron | 5.71 |
Placebo | 4.86 |
[back to top]
Qualiveen Questionnaire
Secondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question) (NCT02086188)
Timeframe: 10 weeks
Intervention | score on a scale (Mean) |
---|
Mirabegron | 0.96 |
Placebo | 0.71 |
[back to top]
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
"Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.~Higher values represent a worse outcome." (NCT02086188)
Timeframe: 5 weeks
Intervention | score on a scale (Mean) |
---|
Mirabegron | 2.8 |
Placebo | 2.23 |
[back to top]
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
"Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.~Higher values represent a worse outcome." (NCT02086188)
Timeframe: 10 weeks
Intervention | score on a scale (Mean) |
---|
Mirabegron | 3.01 |
Placebo | 2.56 |
[back to top]
Mean Volume Voided/Micturition
"Secondary Outcome Measure based on voiding diary:~Baseline vs. Final Visit: Mean volume voided/micturition" (NCT02086188)
Timeframe: 10 weeks
Intervention | ml/micturition (Mean) |
---|
Mirabegron | 356 |
Placebo | 282 |
[back to top]
Mean # of Micturitions/Day Based on Voiding Diaries
"Secondary Outcome Measure based on voiding diary:~Baseline vs Final Visit: mean # of micturitions/day" (NCT02086188)
Timeframe: 10 weeks
Intervention | micturitions/day (Mean) |
---|
Mirabegron | 6.82 |
Placebo | 8.72 |
[back to top]
Change in Mean Daily OAB-SCS Visit 3 vs Baseline
"The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.~The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder." (NCT02092181)
Timeframe: baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)
Intervention | units on a scale (Mean) |
---|
| visit 3 (32-40 days post visit 2 | baseline (7-14 days post visit 1) |
---|
Mirabegron | 3.5 | 3.5 |
,Placebo | 3.07 | 2.6 |
[back to top]
Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
"The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.~The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder." (NCT02092181)
Timeframe: 7-82 days. From visit 2 (baseline) to visit 4
Intervention | units on a scale (Mean) |
---|
Mirabegron | -3.2 |
Placebo | -8.9 |
[back to top]
Change in Mean Number of Incontinence Episodes Per 24 Hours
Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome. (NCT02092181)
Timeframe: baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)
Intervention | episodes per 24 hrs (Mean) |
---|
| V3 vs baseline | V4/baseline |
---|
Mirabegron | -0.06 | 0.12 |
,Placebo | -0.11 | -0.61 |
[back to top]
Non- Motor Symptoms Scale (NMSS)
"Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline.~Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms." (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Intervention | units on a scale (Mean) |
---|
| visit 3/baseline | visit 4/baseline |
---|
Mirabegron | -7.5 | -10.5 |
,Placebo | -19.6 | -17.9 |
[back to top]
Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms. (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)
Intervention | units on a scale (Mean) |
---|
| Week 3/baseline | Week4/baseline |
---|
Mirabegron | -4.14 | -2.6 |
,Placebo | -3.2 | -8.6 |
[back to top]
Patient Perception of Bladder Condition
Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Intervention | units on a scale (Mean) |
---|
| V3/baseline | V4/baseline |
---|
Mirabegron | -0.35 | -0.38 |
,Placebo | -0.7 | -1.2 |
[back to top]
Subjects Global Impression of Change
Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come . (NCT02092181)
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Intervention | units on a scale (Mean) |
---|
| visit 3/baseline | visit 4/baseline |
---|
Mirabegron | 3.5 | 3.5 |
,Placebo | 3.0 | 2.6 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.10 |
Tolterodine ER | 3.08 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Unit on a Scale (Mean) |
---|
Mirabegron | 3.00 |
Tolterodine ER | 3.02 |
[back to top]
Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Intervention | Incontinence Episodes (Least Squares Mean) |
---|
Mirabegron | -1.51 |
Tolterodine ER | -1.46 |
[back to top]
Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
(NCT02138747)
Timeframe: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Intervention | Micturitions (Least Squares Mean) |
---|
Mirabegron | -2.06 |
Tolterodine ER | -1.95 |
[back to top]
Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Least Squares Mean) |
---|
Mirabegron | 86.29 |
Tolterodine ER | 83.40 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 72.98 |
Tolterodine ER | 71.92 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
OAB control was scored from 0 to 100, with higher scores indicating better OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 64.49 |
Tolterodine ER | 63.38 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.43 |
Tolterodine ER | 3.46 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.69 |
Tolterodine ER | 3.69 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 3.70 |
Tolterodine ER | 3.66 |
[back to top]
Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. (NCT02138747)
Timeframe: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Intervention | Units on a Scale (Mean) |
---|
Mirabegron | 69.17 |
Tolterodine ER | 68.31 |
[back to top]
Number of Participants With Adverse Events
Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. (NCT02138747)
Timeframe: Baseline to EOT (Week 18) and follow up (Week 20)
Intervention | Participants (Number) |
---|
| Adverse Events (AEs) | Drug-related (AEs) | Deaths | Serious Adverse Event (SAE) | Drug-related SAEs | AEs Leading to Permanent Discontinuation of Drug | Drug-related AEs Leading to Permanent Discontinuat | SAEs Leading to Permanent Discontinuation | Drug-related SAEs Leading to Permanent Discontinu |
---|
Mirabegron | 150 | 89 | 0 | 3 | 2 | 15 | 12 | 0 | 0 |
,Tolterodine ER | 168 | 111 | 0 | 8 | 0 | 20 | 12 | 5 | 0 |
[back to top]
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (strong preference for period 1, mild preference for period 1, no preference, mild preference for period 2, strong preference for period 2). Participants who selected either a mild preference or strong preference were considered as having a preference for a specific study drug and participants who selected no preference were considered as having no preference for one study drug over the other study drug." (NCT02138747)
Timeframe: Week 18 (End of Period 2)
Intervention | Percentage of participants (Number) |
---|
| Preference for Period 1 | Preference for Period 2 | No Preference | Total With Preference |
---|
AA: Mirabegron/Mirabegron | 36.0 | 36.0 | 28.0 | 72.0 |
,AB: Mirabegron/Tolterodine ER | 29.9 | 37.8 | 32.3 | 67.7 |
,BA: Tolterodine ER /Mirabegron | 34.4 | 37.6 | 28.0 | 72.0 |
,BB: Tolterodine ER /Tolterodine ER | 23.1 | 50.0 | 26.9 | 73.1 |
[back to top]
Change From Baseline in Post-void Residual Volume (PVR)
PVR was assessed by ultrasonography or bladder scan. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | mL (Least Squares Mean) |
---|
Placebo | -3.1 |
Mirabegron | 2.6 |
[back to top]
Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | micturitions/24 hours (Least Squares Mean) |
---|
Placebo | -1.7 |
Mirabegron | -2.3 |
[back to top]
Change From Baseline to EOT in Barthel Index of Daily Living Score
The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 0.4 |
Mirabegron | 0.5 |
[back to top]
Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | incontinence episodes/24 hours (Least Squares Mean) |
---|
Placebo | -1.45 |
Mirabegron | -2.00 |
[back to top]
Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | urgency episodes/24 hours (Least Squares Mean) |
---|
Placebo | -2.81 |
Mirabegron | -3.66 |
[back to top]
Change From Baseline to EOT in OAB-q HRQL Subscale Scores
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
| Coping | Concern | Sleep | Social |
---|
Mirabegron | 18.95 | 19.72 | 16.82 | 11.47 |
,Placebo | 16.36 | 16.89 | 13.46 | 11.15 |
[back to top]
Change From Baseline to EOT in Mean Volume Voided Per Micturition
The mean volume voided per micturition during 3 days of the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | mL (Least Squares Mean) |
---|
Placebo | 17.45 |
Mirabegron | 30.54 |
[back to top]
Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.07 |
Mirabegron | -0.16 |
[back to top]
[back to top]
Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -18.69 |
Mirabegron | -23.39 |
[back to top]
Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.7 |
Mirabegron | -1.0 |
[back to top]
Change From Baseline to EOT in PPIUS
The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.37 |
Mirabegron | -0.54 |
[back to top]
Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 14.455 |
Mirabegron | 20.110 |
[back to top]
Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)
The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 1.33 |
Mirabegron | 1.14 |
[back to top]
Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score
The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | -0.1 |
Mirabegron | -0.3 |
[back to top]
Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | nocturia episodes/24 hours (Least Squares Mean) |
---|
Placebo | -0.21 |
Mirabegron | -0.29 |
[back to top]
Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC
The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
Placebo | 27.1 |
Mirabegron | 36.5 |
[back to top]
Percentage of Participants Who Achieved Micturition Frequency Normalization
Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
Placebo | 36.0 |
Mirabegron | 44.6 |
[back to top]
Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
| Coping | Concern | Sleep | Social |
---|
Mirabegron | 66.1 | 62.2 | 60.1 | 36.9 |
,Placebo | 58.7 | 56.6 | 53.1 | 34.1 |
[back to top]
Number of Participants With Adverse Events (AEs)
Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events. (NCT02216214)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)
Intervention | Participants (Count of Participants) |
---|
| AEs | Related AEs | AEs Leading to Deaths | SAEs | Drug-Related SAEs | AEs Leading to Study Drug Discont. | Drug-related AEs Leading to Study Drug Discont. |
---|
Mirabegron | 209 | 84 | 0 | 15 | 0 | 14 | 10 |
,Placebo | 174 | 57 | 0 | 12 | 2 | 14 | 7 |
[back to top]
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
Placebo | 60.0 |
Mirabegron | 72.4 |
[back to top]
Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC
The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
Placebo | 54.4 |
Mirabegron | 64.7 |
[back to top]
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit. (NCT02216214)
Timeframe: End of treatment (up to 12 weeks)
Intervention | percentage of participants (Number) |
---|
Placebo | 30.4 |
Mirabegron | 38.4 |
[back to top]
Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and Weeks 4, 8 and EOT (up to 12 weeks)
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | EOT |
---|
Mirabegron | -1.44 | -1.77 | -1.94 |
,Placebo | -1.03 | -1.36 | -1.40 |
[back to top]
Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. (NCT02216214)
Timeframe: Baseline and EOT (up to 12 weeks)
Intervention | urgency incontinence episodes/24 hours (Least Squares Mean) |
---|
Placebo | -1.37 |
Mirabegron | -1.93 |
[back to top]
Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.81 | -0.74 | -0.86 | -0.97 | -0.99 | -0.96 | -1.02 | -1.03 |
,Mirabegron + Propiverine | -1.06 | -1.21 | -1.34 | -1.32 | -1.28 | -1.28 | -1.29 | -1.18 |
,Mirabegron + Solifenacin | -1.13 | -1.16 | -1.27 | -1.23 | -1.31 | -1.23 | -1.31 | -1.25 |
,Mirabegron + Tolterodine | -1.09 | -1.21 | -1.23 | -1.33 | -1.28 | -1.07 | -1.18 | -1.15 |
[back to top]
Change From Baseline in the Mean Number of Micturitions Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | micturitions (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -1.23 | -1.62 | -1.74 | -1.86 | -1.97 | -1.80 | -1.82 | -1.75 |
,Mirabegron + Propiverine | -1.44 | -1.89 | -1.90 | -2.21 | -2.10 | -1.97 | -2.08 | -1.89 |
,Mirabegron + Solifenacin | -1.57 | -1.85 | -2.04 | -2.33 | -2.29 | -2.12 | -2.29 | -2.18 |
,Mirabegron + Tolterodine | -1.51 | -1.72 | -2.18 | -2.20 | 2.33 | -1.92 | -1.80 | -1.91 |
[back to top]
Change From Baseline in the Mean Number of Nocturia Episodes Per Night
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | nocturia episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.32 | -0.42 | -0.45 | -0.54 | -0.48 | -0.39 | -0.53 | -0.48 |
,Mirabegron + Propiverine | -0.29 | -0.37 | -0.28 | -0.37 | -0.39 | -0.45 | -0.44 | -0.38 |
,Mirabegron + Solifenacin | -0.33 | -0.42 | -0.45 | -0.49 | -0.42 | -0.53 | -0.55 | -0.47 |
,Mirabegron + Tolterodine | -0.49 | -0.44 | -0.47 | -0.50 | -0.54 | -0.54 | -0.50 | -0.48 |
[back to top]
Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | urgency episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -1.23 | -1.50 | -1.88 | -2.01 | -2.18 | -2.14 | -2.15 | -2.04 |
,Mirabegron + Propiverine | -1.63 | -1.90 | -2.18 | -2.36 | -2.26 | -2.27 | -2.33 | -2.24 |
,Mirabegron + Solifenacin | -1.53 | -1.78 | -2.06 | -2.30 | -2.28 | -2.14 | -2.04 | -2.03 |
,Mirabegron + Tolterodine | -1.49 | -1.89 | -2.10 | -2.26 | -2.28 | -2.19 | -2.26 | -2.07 |
[back to top]
Change From Baseline in the Mean Volume Voided Per Micturition
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | 20.062 | 23.820 | 27.072 | 24.489 | 29.873 | 29.826 | 36.653 | 32.854 |
,Mirabegron + Propiverine | 30.111 | 38.614 | 41.433 | 40.661 | 41.887 | 43.102 | 40.599 | 38.691 |
,Mirabegron + Solifenacin | 30.677 | 38.328 | 39.452 | 39.952 | 36.025 | 43.578 | 41.744 | 40.004 |
,Mirabegron + Tolterodine | 32.854 | 35.351 | 36.598 | 37.786 | 34.823 | 41.378 | 40.548 | 40.683 |
[back to top]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT02294396)
Timeframe: From first dose of study drug up to week 52
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild | Moderate | Severe | Drug-related TEAEs | TEAEs leading to death | Drug-related TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to withdrawal of treatment | Drug-related TEAEs leading to withdrawal of treat. |
---|
Mirabegron + Imidafenacin | 133 | 116 | 15 | 2 | 72 | 0 | 0 | 5 | 0 | 16 | 10 |
,Mirabegron + Propiverine | 135 | 122 | 13 | 0 | 81 | 0 | 0 | 4 | 1 | 19 | 17 |
,Mirabegron + Solifenacin | 131 | 113 | 15 | 3 | 76 | 0 | 0 | 10 | 0 | 23 | 12 |
,Mirabegron + Tolterodine | 120 | 104 | 12 | 4 | 74 | 1 | 0 | 9 | 1 | 18 | 8 |
[back to top]
Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours
"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52
Intervention | urge incontinence episodes (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 40 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -0.72 | -0.71 | -0.79 | -0.87 | -0.85 | -0.91 | -0.93 | -0.91 |
,Mirabegron + Propiverine | -1.00 | -1.14 | -1.25 | -1.22 | -1.10 | -1.14 | -1.14 | -1.12 |
,Mirabegron + Solifenacin | -1.13 | -1.15 | -1.20 | -1.17 | -1.26 | -1.19 | -1.23 | -1.20 |
,Mirabegron + Tolterodine | -0.96 | -1.05 | -1.13 | -1.22 | -1.18 | -1.07 | -1.15 | -1.05 |
[back to top]
Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours
Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 61 |
Mirabegron + Propiverine | 61 |
Mirabegron + Imidafenacin | 69 |
Mirabegron + Tolterodine | 71 |
[back to top]
Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 60 |
Mirabegron + Propiverine | 47 |
Mirabegron + Imidafenacin | 47 |
Mirabegron + Tolterodine | 51 |
[back to top]
Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 70 |
Mirabegron + Propiverine | 77 |
Mirabegron + Imidafenacin | 64 |
Mirabegron + Tolterodine | 76 |
[back to top]
Number of Participants Who Achieved Normalization for OABSS Total Score
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 98 |
Mirabegron + Propiverine | 101 |
Mirabegron + Imidafenacin | 91 |
Mirabegron + Tolterodine | 96 |
[back to top]
Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)
Intervention | Participants (Count of Participants) |
---|
Mirabegron + Solifenacin | 26 |
Mirabegron + Propiverine | 21 |
Mirabegron + Imidafenacin | 21 |
Mirabegron + Tolterodine | 14 |
[back to top]
Change From Baseline in OAB-q SF Total HRQL Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 28 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | 11.06 | 14.88 | 14.67 | 13.99 |
,Mirabegron + Propiverine | 11.35 | 13.05 | 13.89 | 12.46 |
,Mirabegron + Solifenacin | 12.07 | 15.15 | 15.99 | 14.38 |
,Mirabegron + Tolterodine | 12.05 | 12.94 | 15.06 | 14.36 |
[back to top]
[back to top]
Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28 and 52
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 28 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | -2.4 | -3.1 | -3.4 | -3.8 | -3.9 | -4.1 | -3.9 |
,Mirabegron + Propiverine | -3.1 | -3.7 | -4.2 | -4.4 | -4.4 | -4.1 | -4.1 |
,Mirabegron + Solifenacin | -2.9 | -3.5 | -4.0 | -4.1 | -4.0 | -4.0 | -3.9 |
,Mirabegron + Tolterodine | -3.0 | -3.5 | -4.0 | -4.4 | -4.3 | -4.3 | -4.2 |
[back to top]
Change From Baseline in Postvoid Residual (PVR) Volume
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Intervention | mL (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of treatment |
---|
Mirabegron + Imidafenacin | 6.81 | 5.77 | 7.19 | 4.04 | 2.97 | 2.79 | 5.56 | 2.19 | 2.18 | 5.19 | 3.14 | 2.22 | 2.84 | 4.52 |
,Mirabegron + Propiverine | 9.99 | 3.23 | 3.67 | 1.06 | 3.53 | 4.03 | 3.87 | 1.34 | 0.66 | 3.29 | 1.03 | 0.71 | 4.58 | 6.83 |
,Mirabegron + Solifenacin | 9.07 | 10.68 | 4.72 | 7.51 | 2.32 | 4.99 | 2.95 | 0.70 | 4.11 | 6.03 | 2.17 | 2.60 | 3.56 | 8.17 |
,Mirabegron + Tolterodine | 8.21 | 8.39 | 6.04 | 8.67 | 4.68 | 1.46 | 5.07 | 3.11 | 3.12 | 5.40 | 0.50 | 2.33 | 2.02 | 5.94 |
[back to top]
Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning (NCT02436889)
Timeframe: Baseline and 8 weeks
Intervention | seconds (Mean) |
---|
Mirabegron | -11.34 |
Tolterodine Tartrate | 0.67 |
[back to top]
Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
The sum of urge type incontinence episodes reported by participants on a voiding diary per day. (NCT02436889)
Timeframe: Baseline and 8 weeks
Intervention | episodes per day (Mean) |
---|
Mirabegron | -1.64 |
Tolterodine Tartrate | -3.74 |
[back to top]
Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
Range of 0-80, with the higher the score the better. (NCT02436889)
Timeframe: Baseline to Week 8
Intervention | Score on a Scale (Mean) |
---|
Mirabegron | 4.70 |
Tolterodine Tartrate | 1.59 |
[back to top]
[back to top]
Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day. (NCT02436889)
Timeframe: Baseline to Week 8
Intervention | episodes per day (Mean) |
---|
Mirabegron | -2.04 |
Tolterodine Tartrate | -3.91 |
[back to top]
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
"Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study.~Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16).~." (NCT02462837)
Timeframe: 1 week
Intervention | score on a scale (Mean) |
---|
Treatment Arm | 10 |
Placebo Arm | 6.67 |
[back to top]
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16). (NCT02462837)
Timeframe: 2 weeks
Intervention | score on a scale (Mean) |
---|
Treatment Arm | 9.5 |
Placebo Arm | 8 |
[back to top]
Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
Only seven patients were enrolled and two of them withdrew after the fist dose. Therefore, we are only left with 5 patients completing the study. PGI-S is a four item questionnaire asking for patient enumeration of their urinary symptoms when compared to symptoms prior to surgery (1= normal, 2=mild, 3=moderate, 4=severe) (NCT02462837)
Timeframe: 2 weeks
Intervention | score on a scale (Mean) |
---|
Treatment Arm | 2.5 |
Placebo Arm | 2 |
[back to top]
Reduction in Pain Medicine Intake at the 2 Week Follow-up
This outcome measure will be listed in 1) mean number of days that pain medications were taken (NCT02462837)
Timeframe: 2 weeks
Intervention | days (Mean) |
---|
Treatment Arm | 5 |
Placebo Arm | 7.67 |
[back to top]
Reduction in Pain Medicine Intake at the 2 Week Follow-up
This outcome measure will be listed in mean number of times per day that pain medication was taken (NCT02462837)
Timeframe: 2 weeks
Intervention | # times per day pain medication taken (Mean) |
---|
Treatment Arm | 2.22 |
Placebo Arm | 1.4 |
[back to top]
Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Visual analog scale is from 1-10 (10 being the worse possible pain). (NCT02462837)
Timeframe: 1 week, 2 weeks
Intervention | score on a scale (Mean) |
---|
| 1 week follow/up | 2 week follow/up |
---|
Placebo Arm | 2.67 | 1.33 |
,Treatment Arm | 4 | 4.5 |
[back to top]
Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
Change in mean bladder capacity from baseline to final visit based on voiding diary. (NCT02468830)
Timeframe: Participants will be followed for duration of the study, up to 52 weeks
Intervention | milliliter (Median) |
---|
| baseline | Final visit |
---|
Mirabegron | 150 | 200 |
[back to top]
Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy. (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| Complete elimination of urinary incontinence:100% | Significant response > 90%- | Partial response: 50-89% | Failure < 50% |
---|
Mirabegron | 13 | 14 | 25 | 6 |
[back to top]
Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale
"The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit.~Explanation of possible answer:~does not cause me any problems at all,~causes me some very minor problems,~causes me some minor problems,~causes me (some) moderate problems,~causes me severe problems,~causes me many severe problems" (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | units on a scale (Median) |
---|
| baseline | Final visit |
---|
Mirabegron | 4.0 | 2.0 |
[back to top]
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron
Cardiovascular safety: mean difference in heart rate (variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end. (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| No change in heart rate over 20% | No significant change in heart rate |
---|
Mirabegron | 58 | 58 |
[back to top]
Number of Participants With Cardio Vascular Safety
"Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg).~Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication)." (NCT02468830)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| No variation:systolic ±20 mmHg in blood pressure | No variation:Diastolic ±15 mmHg in blood pressure |
---|
Mirabegron | 58 | 58 |
[back to top]
Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy
On voiding diary, participants described their urgency according to the Canadian Urological Association voiding diary, range 0 to 3 at study entry and at study end. (NCT02476175)
Timeframe: up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| Participants with urgency 2-3 at entry | Participants without urgency2-3 at week 52studyend |
---|
Add-on Mirabegron | 32 | 19 |
[back to top]
Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron
Results were based on the International Children's Continence Sociéty classification. Parents or patients supervised by their parents rated symptom relief on a questionnaire as complete cure (definied as dryness) or partial response (reduction of 50% to 99% in incontinence episodes). (NCT02476175)
Timeframe: up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| Complete response:100%improvement of incontinence | Partial response: 50 to 99 % reduction |
---|
Add-on Mirabegron | 12 | 23 |
[back to top]
Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries
"Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6 ( 1 is the best score and 6 is the worst score), at study initiation, every visit and at the study end.~Results will be documented based on subjective relief of symptoms and objective voiding diaries.~Participants perception of bladder condition score at initiation of treatment was:4 and at last follow up score was: 2." (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
Add-on Mirabegron | 35 |
[back to top]
Number of Participants Without Variation in Heart Rate
Cardiovascular safety: mean difference in heart rate (with variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end. (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
Add-on Mirabegron | 35 |
[back to top]
Number of Participants With Cardio Vascular Safety
Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg), blood pressure was taken at each visit and at the study end. (NCT02476175)
Timeframe: Participants will be followed for the duration of the study, up to 52 weeks
Intervention | Participants (Count of Participants) |
---|
| No variation:systolic ±20 mmHg in blood pressure | No variation:Diastolic ±15 mmHg in blood pressure |
---|
Add-on Mirabegron | 35 | 35 |
[back to top]
Change in Urinary Distress Inventory (UDI)
The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | After 12 weeks of therapy | Change Score |
---|
Mirabegron | 121.25 | 69.62 | -51.62 |
[back to top]
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | After 12 weeks of therapy | Change Score |
---|
Mirabegron | 77.85 | 48.55 | -29.30 |
[back to top]
[back to top]
Change in Colo-Rectal-Anal Distress Inventory (CRADI)
The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity. (NCT02495389)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|
| Baseline | After 12 weeks of therapy | Change Score |
---|
Mirabegron | 94.50 | 62.50 | -32.00 |
[back to top]
Change in Montreal Cognitive Assessment Total Score
Change in Montreal Cognitive Assessment Total Score between week 2 and week 14. The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function. Normal range is 26 thru 30. (NCT02536976)
Timeframe: From Week 2 to Week 14
Intervention | units on a scale (Mean) |
---|
Active Treatment | 1.5 |
Placebo | 2 |
[back to top]
Change in Unified Parkinson's Disease Rating Scale
The UPDRS assesses motor and functional abilities of the subjects as it pertains to Parkinson's disease. The total UPDRS score (range 0-199; defined for this study as the sum of Parts I, II, III, and IV (I-Mentation, behavior, and mood section (4 items; range 0-16); II-Activities of Daily Living (ADL; 13 items; range 0-52); III-motor section (27 items; range 0-108) and IV-complications section; 11 items; range 0-23) will be completed by history and examination. Higher scores indicate greater severity of Parkinson's disease symptoms. (NCT02536976)
Timeframe: From Week 2 to Week 14
Intervention | units on a scale (Mean) |
---|
Active | -5.3 |
Placebo | -9 |
[back to top]
Change in Overactive Bladder Questionnaire Subscale Scores
The Overactive Bladder Questionnaire (OABQ) is a 33-item, self-administered instrument that contains a symptom bother scale (8 items) and a health-related quality of life (HRQL) scale (25 items), pertaining to OAB symptoms impact on HRQL. Symptom bother score ranges from 0-100 with higher scores indicating greater severity of symptoms. The HRQL score ranges from 0-100 with higher scores indicating better quality of life. (NCT02536976)
Timeframe: From Week 2 to Week 14
Intervention | units on a scale (Mean) |
---|
| Symptom Severity | HRQL |
---|
Active | -13.3 | 13.7 |
,Placebo | 12.5 | 5 |
[back to top]
Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | urgency incontinence episodes (Mean) |
---|
Placebo | -0.65 |
Mirabegron 50mg | -0.75 |
[back to top]
Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Mean) |
---|
Placebo | -3.4 |
Mirabegron 50mg | -4.4 |
[back to top]
[back to top]
Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
"The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.~Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Mean) |
---|
Placebo | -11.53 |
Mirabegron 50mg | -16.09 |
[back to top]
Change From Baseline to EoT in Postvoid Residual (PVR) Volume
PVR was measured by ultrasonography. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | mL (Mean) |
---|
Placebo | -0.97 |
Mirabegron 50mg | 2.72 |
[back to top]
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | mL (Mean) |
---|
Placebo | 2.632 |
Mirabegron 50mg | 14.995 |
[back to top]
Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | urgency episodes (Mean) |
---|
Placebo | -1.66 |
Mirabegron 50mg | -1.89 |
[back to top]
Change From Baseline to EoT in Mean Number of Nocturia Episodes
A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | nocturia episodes (Mean) |
---|
Placebo | -0.35 |
Mirabegron 50mg | -0.31 |
[back to top]
Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | incontinence episodes (Mean) |
---|
Placebo | -0.72 |
Mirabegron 50mg | -0.77 |
[back to top]
Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Mean) |
---|
Placebo | -2.2 |
Mirabegron 50mg | -2.8 |
[back to top]
Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time). (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | mL (Mean) |
---|
Placebo | 0.20 |
Mirabegron 50mg | -0.25 |
[back to top]
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | micturitions (Mean) |
---|
Placebo | -0.90 |
Mirabegron 50mg | -1.35 |
[back to top]
Change From Baseline to EoT in IPSS Subscale Scores
IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Mean) |
---|
| Storage Subscale | Voiding Subscale-1 | Voiding Subscale-2 | Quality of Life Item |
---|
Mirabegron 50mg | -2.4 | -1.4 | -2.0 | -1.2 |
,Placebo | -1.7 | -1.3 | -1.7 | -0.9 |
[back to top]
Change From Baseline to EoT in OABSS Subscale Scores
"Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)
Intervention | units on a scale (Mean) |
---|
| Daytime Frequency | Nighttime Frequency | Urgency | Urgency Incontinence |
---|
Mirabegron 50mg | -0.3 | -0.3 | -1.5 | -0.7 |
,Placebo | -0.2 | -0.2 | -1.3 | -0.4 |
[back to top]
Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and week 4, 8 and 12
Intervention | micturitions (Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron 50mg | -0.55 | -0.76 | -1.36 |
,Placebo | -0.08 | -0.36 | -0.92 |
[back to top]
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious. (NCT02656173)
Timeframe: From first dose of study drug up to Week 12
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Mild | Moderate | Severe | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | TEAEs leading to discontinuation of study drug | Drug-related TEAEs leading to disc. of study drug |
---|
Mirabegron 50mg | 66 | 56 | 8 | 2 | 11 | 0 | 6 | 0 | 4 | 0 |
,Placebo | 64 | 57 | 6 | 1 | 18 | 0 | 3 | 1 | 4 | 3 |
[back to top]
Spontaneous Stone Passage Using Fisher's Exact Test
The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device. (NCT02744430)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Arm 1 - Active | 8 |
Arm 2 - Placebo | 5 |
[back to top]
Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group. (NCT02744430)
Timeframe: 2 months
Intervention | units on a scale (Mean) |
---|
Arm 1 - Active | 0.21 |
Arm 2 - Placebo | 0.19 |
[back to top]
Number of Participants With Study Drug Acceptability for Oral Suspension at Week 24
"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Smell - Really bad | Smell - Bad | Smell - Not bad, not good | Smell - Good | Smell - Really good | Take - Really difficult | Take - Difficult | Take - Not difficult, not easy | Take - Easy | Take - Really Easy | Prepare - Really difficult | Prepare - Difficult | Prepare - Not difficult, not easy | Prepare - Easy | Prepare - Really Easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
,Children (3 to < 12 Years) | 3 | 1 | 3 | 10 | 6 | 2 | 0 | 8 | 11 | 2 | 0 | 2 | 2 | 6 | 13 | 0 | 1 | 3 | 10 | 9 |
[back to top]
Number of Participants With Study Drug Acceptability for Oral Suspension at Week 52
"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 52
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Smell - Really bad | Smell - Bad | Smell - Not bad, not good | Smell - Good | Smell - Really good | Take - Really difficult | Take - Difficult | Take - Not difficult, not easy | Take - Easy | Take - Really Easy | Prepare - Really difficult | Prepare - Difficult | Prepare - Not difficult, not easy | Prepare - Easy | Prepare - Really Easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
,Children (3 to < 12 Years) | 1 | 2 | 5 | 8 | 6 | 2 | 1 | 5 | 12 | 2 | 0 | 1 | 3 | 7 | 11 | 0 | 0 | 3 | 9 | 10 |
[back to top]
Number of Participants With Study Drug Acceptability for Tablets at Week 24
"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Swallow - Really difficult | Swallow - Difficult | Swallow - Not difficult, not easy | Swallow - Easy | Swallow - Really easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 15 | 6 | 2 | 0 | 0 | 2 | 10 | 11 |
,Children (3 to < 12 Years) | 1 | 2 | 6 | 4 | 4 | 0 | 0 | 2 | 3 | 12 |
[back to top]
Number of Participants With Study Drug Acceptability for Tablets at Week 4
"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 4
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Swallow - Really difficult | Swallow - Difficult | Swallow - Not difficult, not easy | Swallow - Easy | Swallow - Really easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 7 | 4 | 1 | 0 | 0 | 0 | 7 | 5 |
,Children (3 to < 12 Years) | 0 | 0 | 5 | 3 | 1 | 0 | 0 | 1 | 3 | 5 |
[back to top]
Number of Participants With Study Drug Acceptability for Tablets at Week 52
"Participants evaluated the taste of the study medication/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study medication/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT02751931)
Timeframe: Week 52
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Swallow - Really difficult | Swallow - Difficult | Swallow - Not difficult, not easy | Swallow - Easy | Swallow - Really easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 16 | 2 | 2 | 0 | 0 | 2 | 7 | 11 |
,Children (3 to < 12 Years) | 0 | 0 | 8 | 6 | 3 | 0 | 0 | 2 | 4 | 11 |
[back to top]
Apparent Volume of Distribution After Non-intravenous Administration (Vz/F) of Mirabegron
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | Liter (Mean) |
---|
Children PED25 (PKAS) | 14450 |
Adolescents PED25 (PKAS) | 15380 |
Children PED50 (PKAS) | 12150 |
Adolescents PED50 (PKAS) | 14770 |
[back to top]
Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24
Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. Missing MCC observations at week 24 were imputed using last observation carried forward (LOCF). (NCT02751931)
Timeframe: Baseline and week 24
Intervention | mL (Mean) |
---|
Children (3 to < 12 Years) | 72.09 |
Adolescents (12 to < 18 Years) | 113.21 |
[back to top]
Change From Baseline in Maximum Cystometric Capacity at Week 4
Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and week 4
Intervention | mL (Mean) |
---|
Children (3 to < 12 Years) | 41.36 |
Adolescents (12 to < 18 Years) | 80.78 |
[back to top]
Maximum Plasma Concentration (Cmax) of Mirabegron
Cmax was defined as the maximum plasma concentration of mirabegron. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | nanogram/milliliter (ng/mL) (Mean) |
---|
Children PED25 (PKAS) | 9.386 |
Adolescents PED25 (PKAS) | 9.044 |
Children PED50 (PKAS) | 20.55 |
Adolescents PED50 (PKAS) | 18.40 |
[back to top]
Plasma Concentration of Mirabegron at the End of a Dosing Interval at Steady State (Ctrough)
Ctrough was defined as the measured plasma concentration of mirabegron at the end of a dosing interval at steady state. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | ng/mL (Mean) |
---|
Children PED25 (PKAS) | 5.312 |
Adolescents PED25 (PKAS) | 4.114 |
Children PED50 (PKAS) | 9.024 |
Adolescents PED50 (PKAS) | 8.888 |
[back to top]
Time to Reach Maximum Plasma Concentration of Mirabegron Following Drug Administration (Tmax)
Tmax was defined as the time to reach maximum plasma concentration following drug administration. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | hours (Mean) |
---|
Children PED25 (PKAS) | 3.000 |
Adolescents PED25 (PKAS) | 3.500 |
Children PED50 (PKAS) | 3.419 |
Adolescents PED50 (PKAS) | 3.635 |
[back to top]
Change From Baseline in Average Catheterized Volume Per Catheterization
For each participant, the average catheterized volume per catheterization was calculated as the sum of all available/non-missing catheterized volumes recorded over 2 measuring days in the weekend diary, whether or not the 2 days were consecutive divided by the number of catheterizations with non-missing volumes. If volumes were recorded on 1 single day of the weekend diary, the average catheterized volume per catheterization was calculated using all available/non-missing catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend diary, the average catheterized volume per catheterization was missing. A valid bladder diary day in the weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 35.99 | 51.96 | 45.10 | 43.94 | 59.31 | 52.14 | 42.40 |
,Children (3 to < 12 Years) | 14.58 | 30.08 | 36.90 | 32.25 | 41.63 | 53.87 | 42.84 |
[back to top]
Change From Baseline in Average Morning Catheterized Volume
The first morning catheterized volume was the first recorded non-zero volume within or after the hour of the wake-up time on a volume-measuring day in the e-diary. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. If the first morning catheterized volume was recorded on 1 single day of the weekend e-diary, the average morning catheterized is the first morning catheterized that day. If no first morning catheterized volumes are recorded on any day of the weekend e-diary, the average first morning catheterized volume was missing. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 39.52 | 75.25 | 44.43 | 38.23 | 86.66 | 68.47 | 38.14 |
,Children (3 to < 12 Years) | 7.98 | 19.81 | 34.01 | 8.68 | 40.76 | 31.08 | 31.83 |
[back to top]
Change From Baseline in Bladder Compliance (ΔV/ΔP)
Bladder compliance was an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder. Change from baseline in bladder compliance (change in volume/change in pressure) was assessed by the independent central reviewers and reported as annotations on the urodynamic trace and in an external database. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | mL/cm H2O (Mean) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | 15.16 | 13.59 |
,Children (3 to < 12 Years) | -4.09 | 14.62 |
[back to top]
Change From Baseline in Detrusor Pressure at End of Filling
Detrusor pressure was defined as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. Filling was stopped (end of filling) when the detrusor pressure exceeded 100 cm H2O or was considered dangerously high by the investigator or urodynamicist (for instance, a prolonged passive detrusor pressure > 40 cm H2O). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | cm H2O (Mean) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | -6.48 | -13.19 |
,Children (3 to < 12 Years) | -12.38 | -18.11 |
[back to top]
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20)
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | mL (Median) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | 41.15 | 62.00 |
,Children (3 to < 12 Years) | 54.00 | 68.00 |
[back to top]
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | mL (Mean) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | 73.80 | 121.33 |
,Children (3 to < 12 Years) | 56.09 | 93.09 |
[back to top]
Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of > 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. This updated analysis is presented as the original analysis of bladder volume until first detrusor contraction (> 15 cm H2O) did not impute missing bladder volume data with the maximum cystometric capacity (MCC) value at that visit according to the statistical analysis plan (SAP). This analysis was updated to impute missing values for volume at first contraction with respective MCC values. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | mL (Median) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | 46.30 | 78.45 |
,Children (3 to < 12 Years) | 48.00 | 76.00 |
[back to top]
Change From Baseline in Maximum Catheterized Daytime Volume (MCDV)
For each participant, the MCDV was calculated using all available/non-missing catheterized daytime volumes for the 2 measuring days in the weekend e-diary, whether or not the 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the 2 values was used. If volumes were recorded on 1 single day of the weekend e-diary, the MCDV was calculated using all available/non-zero catheterized daytime volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the MCDV was missing. Daytime was defined as the time between wake-up time (minus 30 min) & time to sleep (plus 29 min) recorded in the e-diary. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 35.58 | 70.35 | 38.11 | 43.04 | 81.37 | 50.90 | 49.13 |
,Children (3 to < 12 Years) | 18.13 | 37.71 | 43.91 | 29.05 | 44.20 | 58.49 | 53.76 |
[back to top]
Change From Baseline in Maximum Catheterized Volume
For each participant, the maximum catheterized volume per day was calculated using all available/non-missing catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the two values was used. If volumes recorded on 1 single day of the weekend e-diary, the maximum catheterized volume per day was calculated using all available/non-zero catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the maximum catheterized volume per day was missing. A valid bladder diary day in the weekend diary was any e-diary day for which >=1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | mL (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 42.38 | 73.25 | 42.86 | 47.29 | 84.39 | 54.78 | 54.30 |
,Children (3 to < 12 Years) | 17.50 | 46.69 | 45.27 | 33.23 | 49.88 | 60.09 | 53.51 |
[back to top]
Change From Baseline in Mean Number of Leakage Episodes Per Day
For each participant, the mean number of leakage episodes per day (during day & night time) was calculated using all available/non-missing number of leakage episodes for the 2 measuring days in the weekend diary during day & night time. If the number of leakage episodes was recorded on 1 single day in the 7-day diary during day & night time, the mean number of leakage episodes per day during day & night time is equal to the total number of leakage episodes recorded that day during day & night time. If no leakage episodes were recorded on any day of the weekend diary during day & night time, the mean number of leakage episodes per day was zero. Participants who did not report any leakage episode during the visit were imputed with a '0' for that visit. A valid bladder diary day in the weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | leakage episodes per day (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | -0.53 | -0.87 | -0.65 | -0.65 | -0.75 | -0.81 | -1.12 |
,Children (3 to < 12 Years) | 0.35 | -1.14 | 1.16 | 0.37 | 0.18 | -1.98 | -0.94 |
[back to top]
Change From Baseline in Mean Number of Leakage Episodes Per Day: Updated Analysis
For each participant, the mean number(no.) of leakage episodes per day (during day & night time) was calculated using all available/non-missing no. of leakage episodes for the 2 measuring days in the weekend diary during day & night time. If the no. of leakage episodes was recorded on 1 single day in the 7-day diary during day & night time, the mean no. of leakage episodes per day during day & night time is equal to the total no. of leakage episodes recorded that day during day & night time. If no leakage episodes were recorded on any day of the weekend diary during day & night time, the mean no. of leakage episodes per day was zero. Participants who did not report leakage episode during the visit were imputed with a '0' for that visit. A valid bladder diary day in weekend diary was any e-diary day for which ≥1 catheterized volume >0 mL was recorded with complete date and time. Updated analysis is presented because one participant entered weight of leakage instead of no. of leakages. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | leakage episodes per day (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | -0.71 | -0.95 | -0.84 | -0.86 | -0.98 | -0.98 | -1.05 |
,Children (3 to < 12 Years) | 0.78 | -1.32 | 1.68 | 0.49 | -2.34 | -4.10 | -1.99 |
[back to top]
Change From Baseline in Number of Dry Days Per 7 Days (Day and Night Time)
Dry days were defined as leakage-free days, this included day and night time. Participants recorded dry days in the 7-day diary. Dry days were calculated as follows: Ddry was the number of valid diary days where the response to the question 'Did you leak between this catheterization and the last one' was 'No' each time a new catheterization was entered in the e-diary during the day & night time period. Dwet was the number of valid diary days where the response to the question 'Did you leak between this catheterization and the last one' was 'Yes' for at least one catheterization entered during the day and night time period. If (Ddry + Dwet) > 3, the number of dry days per 7 days was calculated as Ddry/(Ddry + Dwet) x 7, otherwise the value was missing. (NCT02751931)
Timeframe: Baseline and weeks 2, 4, 8, 12, 24, 36 and 52
Intervention | dry days per 7 days (Mean) |
---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 | Change at Week 36 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 0.82 | 1.36 | 2.26 | 1.93 | 2.17 | 1.88 | 2.14 |
,Children (3 to < 12 Years) | 0.34 | 0.68 | 1.14 | 1.31 | 1.34 | 1.33 | 1.38 |
[back to top]
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling
Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. (NCT02751931)
Timeframe: Baseline and weeks 4 and 24
Intervention | overactive detrusor contractions (Mean) |
---|
| Change at Week 4 | Change at Week 24 |
---|
Adolescents (12 to < 18 Years) | -0.64 | -0.77 |
,Children (3 to < 12 Years) | 0.44 | -1.86 |
[back to top]
Change From Baseline in Patient Global Impression of Severity Scale (PGI-S)
"The PGI-S was an answer to the question: How did you feel about your bladder condition during the past 3 days? Participants evaluated their recent condition as Really Bad(0), Bad (1), Not Bad, Not Good (2), Good (3) &Really Good (4). An increase indicated improvement. The total score ranged from 0 to 4, where higher scores indicated improvement.The change from baseline to each postbaseline visit in the PGI-S score is the value at the post-baseline visit minus the value at the baseline visit. If either the baseline or the post-baseline visit value is missing, the change from baseline was missing. A positive change indicated an improvement while a negative change indicated a worsening." (NCT02751931)
Timeframe: Baseline and weeks 24 and 52
Intervention | units on a scale (Mean) |
---|
| Change at Week 24 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | 0.64 | 0.95 |
,Children (3 to < 12 Years) | 0.36 | 0.42 |
[back to top]
Change From Baseline in Pediatric Incontinence Questionnaire (PIN-Q) Score
"PIN-Q measured quality of life via an e-diary. Total score ranged from 0 (no effect) to 80 (worst effect); decrease in score indicated improvement. Total score was 20x average of individual PinQ items, the 20 Likert scales were converted to a score: Items 6 & 17; 0: No to 4: Definitely was used; & For the other 18 items; 0: No to 4: All the time was used. Expectation that questionnaires had limited missing values; if answers >2 questions were missing, total score was not calculated & was missing. Individual item scores were directly imputed. Change from baseline to each post-baseline visit in the total score was post-baseline visit value minus baseline value. If either baseline or post-baseline visit value was missing, change from baseline was missing. If change was: <0, improvement between 2 time-points; =0, no change between 2 time points; >0, worsening between 2 time points." (NCT02751931)
Timeframe: Baseline and weeks 24 and 52
Intervention | units on a scale (Mean) |
---|
| Change at Week 24 | Change at Week 52 |
---|
Adolescents (12 to < 18 Years) | -4.90 | -6.79 |
,Children (3 to < 12 Years) | 2.04 | 1.30 |
[back to top]
Apparent Total Clearance of Mirabegron From Plasma After Oral Administration (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | Liter/hour (L/hr) (Mean) |
---|
Children PED25 (PKAS) | 192.5 |
Adolescents PED25 (PKAS) | 202.3 |
Children PED50 (PKAS) | 230.9 |
Adolescents PED50 (PKAS) | 279.6 |
[back to top]
Number of Participants With Study Drug Acceptability for Oral Suspension at Week 4
"Participants evaluated the taste of the study medication/oral suspension by ticking 1 of the following categories:Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study medication/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption and the preparation of the study medication/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT02751931)
Timeframe: Week 4
Intervention | Participants (Count of Participants) |
---|
| Taste - Really bad | Taste - Bad | Taste - Not bad, not good | Taste - Good | Taste - Really good | Smell - Really bad | Smell - Bad | Smell - Not bad, not good | Smell - Good | Smell - Really good | Take - Really difficult | Take - Difficult | Take - Not difficult, not easy | Take - Easy | Take - Really Easy | Prepare - Really difficult | Prepare - Difficult | Prepare - Not difficult, not easy | Prepare - Easy | Prepare - Really Easy |
---|
Adolescents (12 to < 18 Years) | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
,Children (3 to < 12 Years) | 1 | 3 | 4 | 11 | 3 | 0 | 1 | 8 | 12 | 1 | 0 | 0 | 4 | 7 | 11 | 0 | 0 | 2 | 12 | 8 |
[back to top]
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who was given the study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment. An AE could therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A treatment-emergent adverse event (TEAE) was defined as any AE with date of onset occurring on or after the first dose of study medication and up to the end of study. (NCT02751931)
Timeframe: From the first dose of study drug administration up to end-of-treatment (EoT) (up to week 52)
Intervention | Participants (Count of Participants) |
---|
| TEAE | Drug-related TEAE | Serious TEAE | Drug-related Serious TEAE | TEAE Leading to Death | Drug-related TEAE Leading to Death | TEAE Leading to Permanent Discontinuation | Drug-related TEAE Leading to Permanent Disc. | Death |
---|
Adolescents (12 to < 18 Years) | 18 | 6 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
,Children (3 to < 12 Years) | 33 | 8 | 9 | 0 | 0 | 0 | 3 | 2 | 0 |
[back to top]
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) for Mirabegron
AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose. (NCT02751931)
Timeframe: A total of 4 samples were collected over 2 sampling days at 2 separate visits at any of week 4, 8, 12, 24, 36, or 52, at the following time points: Sampling day 1- Predose; Sampling day 2- Predose and 2 samples 2-5 hours postdose more than 1 hour apart.
Intervention | nanogram*hour/milliliter (Mean) |
---|
Children PED25 (PKAS) | 166.3 |
Adolescents PED25 (PKAS) | 137.8 |
Children PED50 (PKAS) | 310.1 |
Adolescents PED50 (PKAS) | 291.6 |
[back to top]
Number of Participants With Clinician Global Impression of Change (CGI-C)
The Clinician Global Impression of Change (CGI-C) is a 7 point scale that required the clinician to assess how much the participant's overall bladder symptoms since the start of the study on day 1 has improved or worsened and rated as: very much improved (1); much improved (2); minimally improved (3); no change (4); minimally worse (5); much worse (6); or very much worse (7). The total score range from 1-7, where lower scores indicated improvement. (NCT02751931)
Timeframe: Weeks 24 and 52
Intervention | Participants (Count of Participants) |
---|
| Week 24 - Very much Improved | Week 24 - Much Improved | Week 24 - Minimally Improved | Week 24 - No Change | Week 24 - Minimally Worse | Week 24 - Much Worse | Week 24 - Very Much Worse | Week 52 - Very Much Improved | Week 52 - Much Improved | Week 52 - Minimally Improved | Week 52 - No Change | Week 52 - Minimally Worse | Week 52 - Much Worse | Week 52 - Very Much Worse |
---|
Adolescents (12 to < 18 Years) | 10 | 7 | 5 | 1 | 1 | 0 | 0 | 9 | 12 | 1 | 0 | 0 | 1 | 0 |
,Children (3 to < 12 Years) | 6 | 24 | 6 | 4 | 1 | 0 | 0 | 8 | 23 | 5 | 2 | 0 | 0 | 0 |
[back to top]
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Week 12
Intervention | micturitions per day (Least Squares Mean) |
---|
Mirabegron | -2.00 |
Placebo | -1.62 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)
The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
Mirabegron | NA |
Placebo | NA |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 15.6 | 18.6 | 19.1 | 18.4 |
,Placebo | 12.5 | 16.1 | 16.9 | 16.9 |
[back to top]
Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | micturitions per day (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 |
---|
Mirabegron | -1.42 | -1.89 | -1.95 |
,Placebo | -1.32 | -1.38 | -1.56 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). Health-state utility (HSU) data are estimates of the preference for a given state of health on a cardinal numeric scale, where a value of 1.0 represents full health, 0.0 represents dead, and negative values represent states worse than death. Missing EoT values were imputed using LOCF method. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 0.011 | 0.019 | 0.028 | 0.026 |
,Placebo | 0.019 | 0.030 | 0.032 | 0.034 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 10.58 | 16.01 | 18.93 | 18.05 |
,Placebo | 12.47 | 15.25 | 18.03 | 18.02 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 10.43 | 15.32 | 17.94 | 16.87 |
,Placebo | 10.45 | 14.41 | 16.41 | 16.62 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 5.55 | 8.03 | 9.48 | 8.96 |
,Placebo | 6.65 | 8.35 | 9.57 | 9.67 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -3.9 | -5.0 | -5.9 | -5.7 |
,Placebo | -4.0 | -5.2 | -5.5 | -5.6 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -0.9 | -1.3 | -1.5 | -1.4 |
,Placebo | -0.7 | -1.1 | -1.3 | -1.3 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -1.7 | -2.2 | -2.5 | -2.5 |
,Placebo | -2.1 | -2.5 | -2.5 | -2.6 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | incontinence episodes per day (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -0.97 | -1.29 | -1.48 | -1.45 |
,Placebo | -0.84 | -1.20 | -1.23 | -1.15 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | nocturia episodes per 24 hours (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -0.32 | -0.48 | -0.51 | -0.49 |
,Placebo | -0.45 | -0.55 | -0.52 | -0.52 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | urgency episodes per day (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -1.79 | -2.68 | -2.86 | -2.90 |
,Placebo | -1.53 | -1.97 | -2.21 | -2.24 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -2.2 | -2.8 | -3.3 | -3.3 |
,Placebo | -1.9 | -2.6 | -3.0 | -3.0 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 9.06 | 13.34 | 15.64 | 14.81 |
,Placebo | 10.87 | 12.99 | 14.47 | 14.67 |
[back to top]
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). Lower scores on OAB-q symptom bother indicate a better response. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -13.73 | -18.72 | -20.93 | -20.18 |
,Placebo | -11.98 | -14.88 | -18.03 | -18.07 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | units on a scale (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -0.6 | -0.8 | -1.0 | -0.9 |
,Placebo | -0.5 | -0.7 | -0.9 | -0.9 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition during 3 days of the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12
Intervention | mL per micturition (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | 17.74 | 22.56 | 26.31 | 25.57 |
,Placebo | 13.87 | 16.28 | 17.32 | 16.32 |
[back to top]
Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12
Intervention | urgency incontinence episodes per day (Least Squares Mean) |
---|
| Week 4 | Week 8 | Week 12 | EoT |
---|
Mirabegron | -0.97 | -1.29 | -1.52 | -1.49 |
,Placebo | -0.85 | -1.19 | -1.24 | -1.16 |
[back to top]
Number of Participants With Interstitial Cystitis Symptom Improvement
Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire (NCT02787083)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Mirabegron | 1 |
Placebo | 3 |
[back to top]
Number of Participants With Improvement in Incontinence Episodes
Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire (NCT02787083)
Timeframe: 12 weeks
Intervention | Participants (Count of Participants) |
---|
Mirabegron | 1 |
Placebo | 3 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Erectile Function Assessed by IIEF Questionnaire
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Baseline
Intervention | score on a scale (Mean) |
---|
Mirabegron | 12.7 |
[back to top]
[back to top]
Erectile Function Assessed by IIEF Questionnaire
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 8
Intervention | score on a scale (Mean) |
---|
Mirabegron | 17.8 |
[back to top]
Erectile Function Assessed by IIEF Questionnaire
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 4
Intervention | score on a scale (Mean) |
---|
Mirabegron | 15.3 |
[back to top]
Erectile Function Assessed by IIEF Questionnaire
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 2
Intervention | score on a scale (Mean) |
---|
Mirabegron | 13.8 |
[back to top]
Erectile Function Assessed by IIEF Questionnaire
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction. (NCT02916693)
Timeframe: Week 12
Intervention | score on a scale (Mean) |
---|
Mirabegron | 15.8 |
[back to top]
Maximum Concentration (Cmax) For Mirabegron
Cmax for mirabegron was reported from the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Intervention | Nanogram per milliliter (ng/mL) (Geometric Mean) |
---|
Mirabegron 25 mg Fed | 3.07 |
Mirabegron 25 mg Fasted | 7.88 |
Mirabegron 50 mg Fed | 15.9 |
Mirabegron 50 mg Fasted | 33.3 |
[back to top]
Number of Participants With Adverse Events (AE)
"An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered serious if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE." (NCT04501640)
Timeframe: From date of informed consent signed to end of study (up to 24 days)
Intervention | Participants (Number) |
---|
| TEAE | Drug-Related TEAE | Serious TEAE | Drug-Related Serious TEAE | TEAE Leading to Death | Drug-Related TEAE Leading to Death | TEAE Leading to Withdrawal of Treatment | Drug-Related TEAE Leading to Withdrawal of Treatment | Death |
---|
Mirabegron 25 mg Fasted | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 25 mg Fed | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg Fasted | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Mirabegron 50 mg Fed | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
AUCinf for mirabegron was reported for the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Intervention | Hour*nanogram per milliliter (h*ng/mL) (Geometric Mean) |
---|
Mirabegron 25 mg Fed | 81.8 |
Mirabegron 25 mg Fasted | 143 |
Mirabegron 50 mg Fed | 263 |
Mirabegron 50 mg Fasted | 429 |
[back to top]
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
AUClast for mirabegron was reported for the plasma samples collected. (NCT04501640)
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Intervention | h*ng/mL (Geometric Mean) |
---|
Mirabegron 25 mg Fed | 63.3 |
Mirabegron 25 mg Fasted | 119 |
Mirabegron 50 mg Fed | 218 |
Mirabegron 50 mg Fasted | 369 |
[back to top]
Change From Baseline (CFB) to the End of 12-Week Treatment Period in Mean Number of Micturition/24 Hours in Mirabegron 50 mg Group
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline, week 12
Intervention | micturitions per 24 hours (Mean) |
---|
Mirabegron 50 mg | -3.76 |
[back to top]
Change From Baseline to Week 12 in Post Void Residual (PVR) Volume
PVR was assessed by ultrasonography. (NCT04562090)
Timeframe: Baseline, week 12
Intervention | milliliter (Mean) |
---|
Mirabegron 25 mg | -2.7 |
Mirabegron 50 mg | -1.3 |
[back to top]
Number of Participants With Treatment Emergent Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug. (NCT04562090)
Timeframe: From first dose up to 30 days after last dose (up to week 16)
Intervention | participants (Number) |
---|
Mirabegron 25 mg | 18 |
Mirabegron 50 mg | 58 |
[back to top]
Change From Baseline in Mean Number of Daytime Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12
Intervention | incontinence episodes per 24 hours (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Mirabegron 25 mg | -0.48 | -1.06 | -1.03 |
,Mirabegron 50 mg | -0.77 | -0.89 | -0.97 |
[back to top]
Change From Baseline in Mean Number of Grade 3 or 4 Patient Perception of Intensity of Urgency Scale (PPIUS) Urgency Episodes Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which was difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where grade 0 = No urgency; grade 1 = Mild urgency; grade 2 = Moderate urgency, could delay voiding a short while; grade 3 = Severe urgency, could not delay voiding; grade 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12
Intervention | urgency episodes per 24 hours (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Mirabegron 25 mg | -2.09 | -2.66 | -2.57 |
,Mirabegron 50 mg | -2.53 | -2.98 | -3.55 |
[back to top]
Change From Baseline in Mean Number of Micturition Per 24 Hours
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period. (NCT04562090)
Timeframe: Baseline and weeks 4 and 8
Intervention | micturitions per 24 hours (Mean) |
---|
| Change at Week 4 | Change at Week 8 |
---|
Mirabegron 25 mg | -2.06 | -2.65 |
,Mirabegron 50 mg | -2.44 | -3.01 |
[back to top]
Change From Baseline in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12
Intervention | incontinence episodes per 24 hours (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Mirabegron 25 mg | -0.37 | -0.67 | -0.42 |
,Mirabegron 50 mg | -0.47 | -0.45 | -0.54 |
[back to top]
Change From Baseline in Mean Number of Urge Incontinence Episodes Per 24 Hours
An incontinence episode was defined as an episode with any involuntary loss of urine. The mean number of urge incontinence episodes per 24 hours was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and at various specified time-intervals. (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12
Intervention | urge incontinence episodes per 24 hours (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Mirabegron 25 mg | -0.67 | -1.15 | -0.92 |
,Mirabegron 50 mg | -1.18 | -1.25 | -1.36 |
[back to top]
Change From Baseline in OAB Symptom Score (OABSS)
"The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). The total score ranges from 0 to 15 with higher score indicating more symptoms." (NCT04562090)
Timeframe: Baseline and weeks 4, 8, and 12
Intervention | scores on a scale (Mean) |
---|
| Change at Week 4 | Change at Week 8 | Change at Week 12 |
---|
Mirabegron 25 mg | -2.91 | -5.34 | -6.19 |
,Mirabegron 50 mg | -3.01 | -4.29 | -5.43 |
[back to top]
Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 7-day micturition diary period. The analysis was performed with imputation of missing visit 7/week 12 data using the last observation carried forward (LOCF) method. (NCT04641975)
Timeframe: Baseline, week 12
Intervention | micturitions per 24 hours (Least Squares Mean) |
---|
Mirabegron (5 to < 12 Years) | -1.62 |
Placebo (5 to < 12 Years) | -3.84 |
[back to top]
Change From Baseline in Post Void Residual (PVR) Volume
PVR was assessed by ultrasonography. (NCT04641975)
Timeframe: Baseline, weeks 4, 12, 14
Intervention | mL (Mean) |
---|
| Week 12 | Week 14 |
---|
Placebo (12 to < 18 Years) | 0.00 | 0.00 |
[back to top]
Change From Baseline in Post Void Residual (PVR) Volume
PVR was assessed by ultrasonography. (NCT04641975)
Timeframe: Baseline, weeks 4, 12, 14
Intervention | mL (Mean) |
---|
| Week 4 | Week 12 | Week 14 |
---|
Mirabegron (5 to < 12 Years) | -0.56 | 1.63 | 2.20 |
,Mirabegron (12 to < 18 Years) | -3.00 | 5.00 | 4.50 |
,Placebo (5 to < 12 Years) | 8.80 | 5.43 | 11.0 |
[back to top]
Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years
"MVV data was derived from Pee Volume of the 2-day Weekend Episodic Diary. The MVV was the largest (non-zero) volume recorded over both of the 2 (valid) measuring days in the diary. The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12
Intervention | mL (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (With LOCF) |
---|
Mirabegron (5 to < 12 Years) | 26.00 | 26.00 |
,Placebo (5 to < 12 Years) | 26.38 | 26.38 |
[back to top]
Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
A daytime incontinence episode was defined as the complaint of any involuntary leakage of urine during daytime hours. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of daytime incontinence episodes per 24 hours was calculated by taking the sum of all daytime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. (NCT04641975)
Timeframe: Baseline, week 12
Intervention | incontinence episodes per 24 hours (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (with LOCF) |
---|
Mirabegron (5 to < 12 Years) | -1.29 | -1.20 |
,Placebo (5 to < 12 Years) | -1.28 | -1.09 |
[back to top]
Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years
"For a week day the daytime micturitions was derived from Number of Times using the Toilet During the Day was entered into the 5-day Week Diary. For a weekend day the daytime micturitions was derived from the number of times a Pee in Toilet or a Pee in Toilet and Leakage was entered into the 2-day Weekend Episodic Diary between the time the participant woke-up (exclusive). The total number of micturitions per weekend day was equal to the total number of times, in the diary, an amount of pee was recorded during daytime for that day. For each participant, the mean number of daytime micturitions was calculated as:~Sum of the Number of Daytime Micturitions (per day) over the Valid Diary Days prior to Visit/Number of Valid Diary Days.~The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12
Intervention | micturitions per 24 hours (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (with LOCF) |
---|
Mirabegron (5 to < 12 Years) | -0.85 | -0.85 |
,Placebo (5 to < 12 Years) | -3.21 | -3.21 |
[back to top]
Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
A nighttime incontinence episode was defined as the complaint of any involuntary leakage of urine during nighttime hours. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of nighttime incontinence episodes per 24 hours was calculated by taking the sum of all nighttime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. (NCT04641975)
Timeframe: Baseline, week 12
Intervention | incontinence episodes per 24 hours (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (with LOCF) |
---|
Mirabegron (5 to < 12 Years) | -0.64 | -0.64 |
,Placebo (5 to < 12 Years) | -1.34 | -1.34 |
[back to top]
Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years
"Mean volume voided was derived from Pee Volume of the 2-day Weekend Episodic Diary. Mean volume voided per day was calculated as the sum of the volumes voided on that (valid diary) day divided by the number of times a volume was recorded on that day in the 2-day Weekend Episodic Diary. The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12
Intervention | milliliter (mL)/24 hours (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (with LOCF) |
---|
Mirabegron (5 to < 12 Years) | 18.38 | 18.38 |
,Placebo (5 to < 12 Years) | 24.55 | 24.55 |
[back to top]
Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years
"A dry (incontinence free) day was defined as a day where the response is Dry to the question How was your Day and to How was your Night. For a weekend day a Dry (incontinence free) Day was defined a day where no New pee or leakage was reported. Let Ddry be the number of valid diary days where the response to both questions was Dry. Let Dwet be the number of valid diary days where the response to one of the two questions or to both questions was Wet. If (Ddry + Dwet) > 3, the number of dry days per 7 days was calculated as Ddry/(Ddry + Dwet)* 7, otherwise the value was missing.~The analysis was performed with LOCF and without LOCF method." (NCT04641975)
Timeframe: Baseline, week 12
Intervention | incontinence-free days (Mean) |
---|
| Week 12 (without LOCF) | Week 12 (with LOCF) |
---|
Mirabegron (5 to < 12 Years) | 3.12 | 2.94 |
,Placebo (5 to < 12 Years) | 1.45 | 1.46 |
[back to top]
Number of Participants With Study Drug Acceptability and Palatability for Oral Suspension
"Participants evaluated the taste of the study drug/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the smell of the study drug/oral suspension by ticking 1 of the following categories: Really Bad (0), Bad (1),Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the consumption of the study drug/oral suspension by ticking 1 of the following categories: Really Difficult (0),Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4). Participants evaluated the preparation of the study drug/oral suspension by ticking 1 of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) & Really Easy (4)." (NCT04641975)
Timeframe: Week 12
Intervention | Participants (Number) |
---|
| Taste: Really Bad | Taste: Bad | Taste: Not Bad, Not Good | Taste: Good | Taste: Really Good | Smell: Really Bad | Smell: Bad | Smell: Not Bad, Not Good | Smell: Good | Smell: Really Good | Taking: Really Difficult | Taking: Difficult | Taking: Not Difficult, Not Easy | Taking: Easy | Taking: Really Easy | Preparing: Really Difficult | Preparing: Difficult | Preparing: Not Difficult, Not Easy | Preparing: Easy | Preparing: Really Easy |
---|
Mirabegron (5 to < 12 Years) | 0 | 0 | 4 | 1 | 1 | 0 | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 4 | 2 |
,Placebo (5 to < 12 Years) | 0 | 0 | 6 | 1 | 0 | 0 | 0 | 4 | 2 | 1 | 0 | 0 | 1 | 5 | 1 | 0 | 0 | 2 | 5 | 0 |
[back to top]
Number of Participants With Study Drug Acceptability and Palatability for Tablets
"Participants evaluated the taste of the study drug/tablets by ticking 1 of the following categories: Really Bad (0), Bad (1), Not Bad, Not Good (2), Good (3) & Really Good (4). Participants evaluated the swallow of the study drug/tablets by ticking one of the following categories: Really Difficult (0), Difficult (1), Not Difficult, Not Easy (2), Easy (3) and Really Easy (4)." (NCT04641975)
Timeframe: Week 12
Intervention | Participants (Number) |
---|
| Taste: Really bad | Taste: Bad | Taste: Not Bad, Not Good | Taste: Good | Taste: Really Good | Swallow: Really Difficult | Swallow: Difficult | Swallow: Not Difficult, Not Easy | Swallow: Easy | Swallow: Really Easy |
---|
Mirabegron (12 to < 18 Years) | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
,Mirabegron (5 to < 12 Years) | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 1 |
,Placebo (5 to < 12 Years) | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was any untoward medical occurrence in a participant administered a study drug and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last dose. (NCT04641975)
Timeframe: From first dose up to week 14
Intervention | Participants (Number) |
---|
| Treatment emergent adverse events | Serious treatment emergent adverse events |
---|
Mirabegron (12 to < 18 Years) | 1 | 1 |
,Mirabegron (5 to < 12 Years) | 5 | 0 |
,Placebo (12 to < 18 Years) | 1 | 1 |
,Placebo (5 to < 12 Years) | 7 | 0 |
[back to top]
[back to top]
[back to top]
Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)
This is a quality of life measure using a validated questionnaire called the Urinary Distress Index Scale with a range from 0-100 with higher scores meaning worse urinary distress such as urinary incontinence and leakage and bother with the life stresses related to urinary incontinence. Will include a baseline measure pre-trial and then a post-trial measure (post-trial). This includes a pre-trial measure (baseline) and a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: 12 weeks
Intervention | score on a scale (Mean) |
---|
Posterior Tibial Nerve Stimulation With Mirabegron | 23.6 |
Posterior Tibial Nerve Stimulation Plus Placebo | 16.3 |
[back to top]
Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks
change in the number of urgency urinary incontinence episodes as measures by a 3-day voiding diary pre- vs. post-treatment. This includes a baseline measure pre-trial and then a post-trial measure in 12 weeks and then you calculate the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: 3 day voiding diary will be filled out prior to the 12 week PTNS trial and voiding diary will be filled out immediately after the 12 week PTNS trial
Intervention | UUI episodes (Mean) |
---|
Posterior Tibial Nerve Stimulation With Mirabegron | 9.4 |
Posterior Tibial Nerve Stimulation Plus Placebo | 5.3 |
[back to top]
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks)
The IIQ-7 (Incontinence Impact Questionnaire) is a measure of distress caused by urge urinary incontinence and overactive bladder in the patient. This scale is a scale of 0-100 with 0 being minimal impact and 100 being worse impact and distress. This includes a baseline pre-trial measure and a post-trial measure at 12 weeks. This includes a pre-trial measure (baseline) and then a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact.
Intervention | score on a scale (Mean) |
---|
Posterior Tibial Nerve Stimulation With Mirabegron | 29.7 |
Posterior Tibial Nerve Stimulation Plus Placebo | 20.2 |
[back to top]
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)
This is the change in Quality of life measure for urge urinary incontinence for the OABq SF scale and it is a 0-100 scale where 0 equals minimum symptoms and 100 equals maximal symptoms. Lower scores indicate better quality of life and higher scores indicate worse quality of life. This includes a pre-trial measure and a post-trial measure at 12 weeks and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. (NCT04907032)
Timeframe: pre trial measurements as described and then 12 weeks later post-trial measurements as described.
Intervention | score on a scale (Mean) |
---|
Posterior Tibial Nerve Stimulation With Mirabegron | 53.6 |
Posterior Tibial Nerve Stimulation Plus Placebo | 33.3 |
[back to top]