tolterodine-tartrate and Nocturia

Nocturia is a prevalent symptom with varied aetiology and no consensus on treatment options.. We systematically reviewed evidence comparing the benefits and harms of various treatment options for nocturia or nocturnal incontinence in women.. Literature search was performed using Embase, Medline, and Cochrane databases (from 1 January 1946 to 26 September 2017), following the methods detailed in the Cochrane Handbook. The protocol was registered with PROSPERO. Certainty of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.. The literature search identified 3573 citations, of which 11 full-text articles were included. Three studies on desmopressin and four on antimuscarinics provided evidence of improving nocturia symptoms. Four studies on behavioural treatment provided limited evidence and controversial results. One study on oestrogen did not prove the benefit of any mode of administration, and one small study on functional magnetic stimulation provided some evidence of effectiveness in nocturia. One randomised controlled trial (RCT; 141 participants) reported a statistically significant difference between the desmopressin and placebo groups (desmopressin patients experienced 0.75 [95% confidence interval {CI} 0.47-1.03] nocturia episodes less than those experience by the placebo group; certainty of evidence = low). The only RCT on antimuscarinics in women with nocturia reported that oxybutynin reduced the number of nocturia episodes by 0.3 (95% CI -0.02 to 0.62) versus placebo. In one RCT comparing tolterodine with the combination of tolterodine with behavioural therapy, there was significant change from baseline nocturnal incontinence episodes in both groups.. There is some evidence that desmopressin and antimuscarinics are effective treatment options for nocturia; however, there is very limited evidence for other treatment options. The findings should be interpreted with caution as there were some methodological flaws in the included studies, particularly outcome heterogeneity.. This review identified several medical treatments for nocturia in women, such as desmopressin and antimuscarinics, which appear to improve the severity of the condition.

Topics: Adult; Deamino Arginine Vasopressin; Female; Humans; Middle Aged; Muscarinic Antagonists; Nocturia; Randomized Controlled Trials as Topic; Tolterodine Tartrate

A systematic review and meta-analysis was carried out to evaluate the efficacy and safety of mirabegron 50 mg and 100 mg in the treatment of storage lower urinary tract symptoms/overactive bladder in comparison with a placebo and tolterodine 4 mg. A total of 491 articles were collected and eight randomized studies were identified as eligible for this meta-analysis. Overall, eight trials were included in the meta-analysis evaluating 10 248 patients. Mirabegron at both doses of 50 mg and 100 mg, and and tolterodine 4 mg were significantly associated with the reduction of incontinence episodes per 24 h, reduction of mean number of micturitions per 24 h, increase of voided volume and reduction of urgency episodes per 24 h, compared to a placebo. Both mirabegron 50 mg and mirabegron 100 mg were associated with a significant reduction of nocturia episodes when compared with a placebo. Conversely, tolterodine 4 mg did not prove to be more effective than a placebo in the reduction of nocturia episodes. Furthermore, mirabegron 50 mg showed a slightly, but significantly, better efficacy than tolterodine 4 mg in the improvement of nocturia episodes. Mirabegron 50 mg and mirabegron 100 mg shared the same risk of overall treatment-emergent adverse events rate with the placebo. Otherwise, tolterodine 4 mg was associated with a significantly greater risk than the placebo. However, mirabegron 100 mg showed a slight trend toward an increased risk of hypertension (odds ratio 1.41; P = 0.08) and cardiac arrhythmia (odds ratio 2.18; P = 0.06). Mirabegron is an effective treatment for patients with storage lower urinary tract symptoms/overactive bladder, providing a reduction of incontinence, urgency and frequency; an improvement of voided volume with a slight, but statistically, significant improvement of nocturia; with a good safety profile. These findings should be considered for the treatment planning of patients with storage lower urinary tract symptoms/overactive bladder.

Topics: Acetanilides; Humans; Lower Urinary Tract Symptoms; Nocturia; Randomized Controlled Trials as Topic; Thiazoles; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

Antimuscarinics (AMs) are the mainstay of pharmacological treatment of overactive bladder (OAB), a symptom complex defined by the presence of urinary urgency, usually associated with frequency and nocturia, with or without urgency urinary incontinence. The AMs used to treat OAB differ in their pharmacological profiles, which may affect their potential for causing adverse effects (AEs).. The present article aims to review the literature about pharmacokinetics (PK) of the different AMs used in the treatment of OAB. Furthermore, the AEs related to the use of these drugs and their incidence are presented. This systematic review is based on material searched and obtained via Medline, Pubmed and EMBASE up to March 2012 using the search terms "adverse events, pharmacokinetics, tolerability" in combination with "darifenacin, fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium.". Antimuscarinics are the first-line pharmacological treatment for OAB. Despite the development of new molecules that improve their efficacy/safety profile, there are some drugs that are pharmacokinetically more appropriate to be prescribed in specific populations such as patients with neurological disease or the elderly. Moreover, research should be encouraged in evaluating antimuscarinics in conjunction with other drugs such as estrogens or beta-agonists. The identification of prognostic criteria for pharmacological therapy would be helpful.

Topics: Benzhydryl Compounds; Benzilates; Benzofurans; Chronic Disease; Cresols; Drug Combinations; Female; Humans; Imidazoles; Mandelic Acids; Muscarinic Antagonists; Nocturia; Phenylpropanolamine; Pyrrolidines; Quinuclidines; Solifenacin Succinate; Tetrahydroisoquinolines; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Incontinence

Evaluation of safety and efficacy of desmopressin/tolterodine combination therapy in women.. This double-blind, randomized, proof-of-concept study enrolled 106 patients (≥18 years), with overactive bladder (OAB) and nocturia, with ≥2 nocturnal voids, receiving a 3-month once-daily combination (desmopressin 25 µg, orally-disintegrating tablets [ODT]/tolterodine 4 mg [Detrol® LA]; n = 49) or monotherapy (tolterodine 4 mg/placebo ODT; n = 57). Primary endpoint was change from baseline in mean number of nocturnal voids. Secondary endpoints were change from baseline in nocturnal voided volume, time to first nocturnal void, and quality-of-life. Post-hoc exploratory analysis were performed for patients with and without baseline nocturnal polyuria (NP, n = 47 each).. Overall population showed a non-significant reduction in mean number of nocturnal voids with combination versus monotherapy (full analysis set: adjusted treatment contrast [TC], -0.34; P = 0.112). Change in mean nocturnal void volume (TC, -64.16 mL; P = 0.103), mean time to first nocturnal void (TC, 18.00 min; P = 0.385) and Nocturia Impact (NI) Diary. Low-dose desmopressin could be safely combined with tolterodine for treating nocturia in women with OAB, with a significant benefit in women with NP. Further, prospective validation studies of combination therapy are warranted in mixed NP/OAB population, based on this favorable proof-of-concept finding.

Topics: Adult; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Drug Combinations; Female; Humans; Middle Aged; Nocturia; Proof of Concept Study; Quality of Life; Time Factors; Tolterodine Tartrate; Urinary Bladder, Overactive; Urine; Urological Agents

To compare the efficacy of pelvic floor muscle exercises (PFME) using weighted vaginal cones (WVC) on the symptoms, clinical findings, urodynamic findings and quality of life (QoL) in overactive bladder (OAB) patients with tolterodine.. Thirty-nine patients with urinary frequency (≥ 8/day), nocturia (≥ 2/night), urgency and a total score of ≥ 8 to the overactive bladder-awareness tool (OAB-V8) were diagnosed as OAB and were randomized into two treatment groups; WVC and extended release tolterodine (tolterodine ER) 4 mg/day for 8 weeks. Results of the clinical findings, 3-day urinary diary, validated questionnaires for symptom bother and QoL (Urinary distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), OAB-V8, Wagner questionnaire) and urodynamic examination before and after treatment were compared.. A reduction of frequency, nocturia and urinary incontinence was observed in WVC group (p=0.006, p=0.034 and p=0.008, respectively) and in tolterodine group (p<0.001, p=0.002 and p=0.035, respectively). 24-h dry pad test results were improved significantly in both groups (p=0.003 and p=0.001, respectively). Pelvic muscle strength was significantly improved in WVC group but not in tolterodine group (p=0.010 and p=0.180, respectively). UDI-6, IIQ-7, OAB-V8 scores were improved significantly in both groups. Improvements in Wagner questionnaire were observed in WVC group but not in tolterodine group (p=0.002 and p=0.591, respectively). First sensation of bladder filling was significantly improved after WVC treatment but not in tolterodine group (p=0.035 and p=0.550, respectively). After treatment, detrusor overactivity (DO) resolved in 8 patients in the WVC group (p=0.003) and in 2 patients in the tolterodine group (p=0.426).. WVC treatment seems to be an efficacious therapeutic option for the improvement of overactive bladder syndrome (OABS).

Topics: Adult; Female; Humans; Middle Aged; Muscarinic Antagonists; Nocturia; Pelvic Floor; Physical Therapy Modalities; Quality of Life; Surveys and Questionnaires; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence; Urodynamics; Vagina

To determine whether participants in the behavior enhances drug reduction of incontinence (BE-DRI) trial experienced reduction in the frequency of nocturia and/or nocturnal leakage during treatment with antimuscarinic phamacotherapy with or without additional behavioral therapy. We analyzed urinary diary data relating to nocturia and nocturnal incontinence before and after 8 weeks of study treatment in the BE-DRI trial, in which patients were randomly assigned to receive drug therapy with tolterodine tartrate extended-release capsules 4 mg alone or in combination with behavioral training. Chi-square tests assessed whether nocturia and nocturnal incontinence prevalence varied by treatment arm and paired t tests assessed the change in mean frequency of nocturia and nocturnal leakage. Among 305 women, 210 (69%) had an average of at least one nocturia episode at baseline. There were small but statistically significant differences (p < 0.001) in mean nocturia frequency and nocturnal incontinence frequency with both treatments after 8 weeks, but no significant difference between study treatment groups. Among these urge incontinent women, tolterodine with or without supervised behavioral therapy had little impact on either nocturic frequency or nocturnal incontinence.

Topics: Administration, Oral; Behavior Therapy; Benzhydryl Compounds; Cholinergic Antagonists; Cresols; Delayed-Action Preparations; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Middle Aged; Muscarinic Antagonists; Nocturia; Nocturnal Enuresis; Phenylpropanolamine; Prevalence; Tolterodine Tartrate; Treatment Outcome; United States; Urodynamics

We have studied the association between various symptoms, bother, and patient treatment satisfaction in overactive bladder (OAB).. Episodes of urgency, incontinence, daytime frequency and nocturia and responses to the patient perception of bladder condition scale, the urgency perception scale, and visual analog scales of limitations in daily life and of treatment satisfaction were evaluated in 3,824 OAB patients at baseline and during 9 months treatment with tolterodine ER (4 mg q.d.) in an open-label, observational study. Relationships amongst number of symptoms/ 24 hr and scales were explored. Treatment satisfaction was correlated with improvements in symptoms and scales.. At baseline, the number of episodes of the four OAB symptoms correlated only poorly with each other and with the two bother-related scales, while the two scales assessing bother correlated much stronger with each other. Factor analysis identified four components which described "bother," "incontinence," "urgency/frequency," and "nocturia" and in combination explained 81.9% of the total variance. The component "bother" had the strongest individual effect accounting for 42.1% of the total variance. While improvements of symptoms and bother were seen with tolterodine treatment, patient treatment satisfaction correlated strongest with improvements of the two bother-related scales.. We conclude that the counting of episodes of OAB symptoms only insufficiently describes the afflicted patients. Patient bother is the strongest individual component but only poorly explained by episodes of the four symptoms defining OAB. Alterations of bother may better reflect patient-relevant outcomes in OAB treatment than alterations in the number of symptom episodes.

Topics: Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Cluster Analysis; Cresols; Delayed-Action Preparations; Factor Analysis, Statistical; Female; Humans; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Patient Satisfaction; Phenylpropanolamine; Principal Component Analysis; Statistics, Nonparametric; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence

Nocturia is caused by increased nocturnal urine output (nocturnal polyuria) and/or diminished nocturnal bladder capacity. We retrospectively evaluated the causes of nocturia in patients with overactive bladder and nocturia.. A total of 850 patients (18 years or older) with symptoms of overactive bladder (8 or more micturitions per 24 hours and urgency or urgency urinary incontinence) and nocturia (mean of 2.5 or more episodes per night) were enrolled in a 12-week study of tolterodine ER (4 mg QD) vs placebo. Of this total 845 patients (417 men and 428 women) completed 7-day bladder diaries. Patients were stratified post hoc by sex and age groups (less than 50, 50 to 70, more than 70 years). Indices of nocturnal urine production (nocturia index, nocturnal polyuria index and nocturnal bladder capacity index) were compared using ANOVA (alpha level 0.05). Higher nocturia index and nocturnal polyuria index values suggest that nocturia occurs because of nocturnal urine overproduction. Higher nocturnal bladder capacity index values suggest that nocturia occurs because of decreased nocturnal bladder capacity.. There were no statistically significant gender or age related differences in baseline nocturnal micturitions. Nocturia index increased significantly with age (p <0.0001), and values were significantly higher among men than women for all age groups (p = 0.0064). Nocturnal polyuria index increased significantly with age (p <0.0001) and there were no gender differences. For nocturnal bladder capacity index there was a significant decrease with advancing age among men (1.75 greater than 1.16 greater than 0.90) and women (1.53 greater than 1.42 greater than 1.08, P(interaction) = 0.0148).. In younger patients with overactive bladder, decreased nocturnal bladder capacity has a greater role in the pathogenesis of nocturia symptoms, whereas in older patients increased nocturnal urine output has a greater role.

Topics: Age Factors; Aged; Benzhydryl Compounds; Cresols; Double-Blind Method; Female; Humans; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Phenylpropanolamine; Polyuria; Retrospective Studies; Sex Factors; Tolterodine Tartrate; Urinary Bladder, Overactive; Urodynamics

We aimed to clarify the impact of night-time dosing with tolterodine extended release (ER) on nocturia.. The bladder diaries, urodynamic studies, and medical records of female patients with overactive bladder syndrome who were diagnosed between January 2005 and December 2015, and treated with tolterodine ER 4 mg once per day (night-time or daytime dosing) for 12 weeks in the urogynecology outpatient clinics of two tertiary referral centers were reviewed retrospectively.. A total of 72 female patients were reviewed. Thirty-six patients were in the daytime dosing group, and the other 36 patients were in the night-time dosing group. In the daytime dosing group, a decrease in the volume of fluid intake was found at 06.00-12.00, 12.00-18.00, and 18.00-24.00 hours, and a decrease in total voided volume was found at 12.00-18.00, 18.00-24.00, and 24.00-06.00 hours with a between-group difference at 18.00-24.00 hours (coefficient = 542 mL, P = 0.01). In the night-time dosing group, an increase in voided volume per micturition was found at 06.00-12.00 and 24.00-06.00 hours with a between-group difference at 24.00-6.00 hours (coefficient = 92 mL, P = 0.003) compared with the daytime dosing group. Nonetheless, pre-treatment proportions of nocturnal polyuria did not differ from post-treatment proportions (night-time: 20% vs 20%, P = 1.00; daytime: 48% vs 42%, P = 0.48). Decreases in the number of voiding and urgency episodes at nearly all time periods and increases in the volumes at strong desire to void were also found in both groups.. Night-time dosing of tolterodine ER may benefit female patients suffering from nocturia due to a greater voided volume per micturition at midnight.

Topics: Adult; Aged; Female; Humans; Middle Aged; Nocturia; Time Factors; Tolterodine Tartrate; Urinary Bladder, Overactive; Urological Agents

To investigate the characteristics of autonomic function and arterial stiffness of OAB women, their relations with urodynamic parameters, and the impact of antimuscarinics on the above parameters.. A total of 85 OAB women and another 65 women without OAB were selected. Forty-two OAB women who enrolled before March 2009 were treated with tolterodine for 12 weeks, and another 43 OAB women who enrolled thereafter were treated with solifenacin.. The differences of the heart rate variability, cardio-ankle vascular index (CAVI) and ankle-brachial pressure index (ABI) between OAB and asymptomatic women, and their changes after 12 weeks' antimuscarinics for OAB women.. OAB women had higher low frequency/high frequency ratios (LF/HF) (OAB: 1.5±1.1 vs. the control: 1.1±0.7, P=0.04). Nonetheless, CAVI and ABI did not differ between OAB and the control group. The square root of the mean squared differences of successive NN intervals (RMSSD) is associated with nocturia (Spearman's ρ=0.23, P=0.049), LF is associated with urgency episodes (Spearman's ρ=0.28, P=0.01), and maximum urethral closure pressure is negatively associated with CAVI (Spearman's ρ=-0.26, P=0.02). After 12 weeks' treatment, a decrease of RMSSD, HF, CAVI and an increase of LF/HF were found in the tolterodine group but not in the solifenacin group.. OAB women have higher severity of autonomic dysfunction with sympathetic predominance. Tolterodine may improve arterial stiffness but may deteriorate autonomic dysfunction to more sympathetic predominance. Thus, tolteridine should be used for OAB with caution in women with preexisting symptoms of autonomic dysfunction.

Topics: Adult; Ankle Brachial Index; Blood Pressure; Electrocardiography, Ambulatory; Female; Heart Rate; Humans; Middle Aged; Muscarinic Antagonists; Nocturia; Pressure; Solifenacin Succinate; Tolterodine Tartrate; Urethra; Urinary Bladder, Overactive; Urinary Incontinence; Urination; Urodynamics; Vascular Stiffness

The aim of this study was to compare the changes in urinary symptoms and urodynamic parameters after administration of tolterodine in women with an overactive bladder (OAB).. Thirty-eight women diagnosed with OAB and treated with tolterodine were reviewed. Urinalysis, pelvic examination, 3-day bladder diary, urodynamic study, and a personal interview to identify urinary symptoms prior to and 3 months after treatment were recorded and interpreted.. Most of our patients were menopausal (76.3%; mean age 55.7 years) and multiparous (mean parity 3.3) women. Urinary symptoms such as urinary frequency, urgency, urge incontinence, and nocturia were decreased significantly (p < 0.05). All urodynamic parameters did not change significantly except for the maximum cystometric capacity (p < 0.05), showing a significant increase after 3 months of medication.. Tolterodine, at a recommended dose, improves the symptoms of OAB syndrome without causing urine retention, as proved by the changes of urodynamic parameters.

Topics: Adult; Aged; Benzhydryl Compounds; Cresols; Female; Humans; Menopause; Middle Aged; Nocturia; Parity; Phenylpropanolamine; Pregnancy; Retrospective Studies; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urodynamics; Urological Agents

OBJECTIVES To evaluate the number of medical and urological conditions associated with nocturia in a cohort of older men who were primary-care enrolees, and to assess the feasibility and efficacy of using a multicomponent intervention to reduce nocturia and its bother. SUBJECTS AND METHODS Men aged > or =50 years and with two or more episodes of nocturia were recruited from the primary-care clinics at one Veterans Affairs Medical Center to participate in a 4-week, open-label, prospective pilot study. A multicomponent intervention composed of behavioural therapy and targeted drug therapy was administered according to a specified protocol based upon identified risk factors for nocturia. Outcome measures included self-reported nocturia and bother on the American Urological Association (AUA)-7 Symptom Index, 3-day bladder diaries and self-reported sleep-related measures recorded using 7-day sleep diaries. RESULTS Fifty-five men completed the protocol (mean age 67 years, sd 8.3); they had a mean of 4.5 of nine defined conditions potentially related to nocturia. Highly prevalent conditions included moderate-to-severe benign prostatic hyperplasia (87%), hypertension (86%) and urinary frequency (71%). The mean diary-recorded nocturia decreased from 2.6 to 1.9 (P < 0.001), and bother score reduced from 3.1 to 1.1, representing a change from a 'medium' to a 'very small' problem (on a 5-point scale). Sleep diary-derived measures also improved significantly (time to initiate sleep, time to return to sleep after awakening, quality of sleep). CONCLUSIONS Given that individual older patients often have multiple coexistent risk factors for nocturia, identifying a principal cause of nocturia, a concept emphasized in treatment guidelines, proved to be difficult. Implementing a multicomponent behavioural intervention combined with drug(s) was feasible in older men and reduced nocturia frequency, bother from nocturia, and time to initiate sleep, within 4 weeks. These promising results merit repeating using a randomized, controlled trial.

Topics: Acetamides; Adrenergic alpha-Antagonists; Aged; Behavior Therapy; Benzhydryl Compounds; Combined Modality Therapy; Cresols; Epidemiologic Methods; Humans; Hypnotics and Sedatives; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Phenylpropanolamine; Prazosin; Prostatic Hyperplasia; Pyrimidines; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive