mirabegron and Urinary-Bladder--Neurogenic

Systematic review.. To evaluate the efficacy and safety of mirabegron in patients with neurogenic detrusor overactivity due to SCI or MS.. A comprehensive search of the Pubmed, Cochrane, Scopus, and Embase databases was performed. Studies evaluating adult patients with neurogenic detrusor overactivity due to SCI or MS were analyzed according to clinical and urodynamic outcome parameters.. A total of 488 patients were included in 11 studies, with sample sizes ranging from 15 to 91. The duration of the treatments varied from 4 weeks to 12 months. Mirabegron was used as a secondline treatment after anticholinergics in most of the studies. While clinical outcome parameters are used in studies involving only MS patients, urodynamic outcome parameters are also used in studies involving patients with SCI. The efficacy of mirabegron was found not to be different than anticholinergics when compared in MS patients. Comprehensive urodynamic evaluation was performed in 2 randomized, double-blind, placebo-controlled studies and no satisfactory results were obtained compared to placebo. In retrospective studies there were some significant improvements in P. Although mirabegron demonstrates similar clinical efficacy to anticholinergics in MS patients, its effect on urodynamic parameters in patients with SCI cannot be considered satisfactory. It has a good safety profile with mild cardiovascular side effects.

Topics: Acetanilides; Adult; Cholinergic Antagonists; Humans; Multiple Sclerosis; Randomized Controlled Trials as Topic; Retrospective Studies; Spinal Cord Injuries; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urodynamics

Overactive bladder (OAB) symptoms of frequency, urgency and urge incontinence are frequently associated with known neurological diseases like multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's disease (PD), stroke.. The aim of our study was to review the efficacy of pharmacological and non-pharmacological treatments for neurogenic overactive bladder.. We searched two electronic databases (PubMed and EMBASE) for randomized controlled trials focusing on pharmacological and non-pharmacological medical treatments for overactive bladder symptoms associated with neurological diseases published up to 30 April 2022.. A total of 157 articles were retrieved; 94 were selected by title and abstract screening; after removal of 17 duplicates, 77 records were evaluated by full-text examination. Sixty-two studies were finally selected. The articles selected for review focused on the following interventions: anticholinergics (n = 9), mirabegron (n = 5), comparison of different drugs (n = 3), cannabinoids (n = 2), intravesical instillations (n = 3), botulinum toxin (n = 16), transcutaneous tibial nerve stimulation (TTNS) (n = 6), acupuncture (n = 2), transcutaneous electrical nerve stimulation TENS (n = 4), pelvic floor muscle training (PFMT) (n = 10), others (n = 2). Anticholinergics were more effective than placebo in decreasing the number of daily voids in patients with PD (mean difference [MD]- 1.16, 95 % CI - 1.80 to - 0.52, 2 trials, 86 patients, p < 0.004), but no significant difference from baseline was found for incontinence episodes and nocturia. Mirabegron was more effective than placebo in increasing the cystometric capacity in patients with MS (mean difference [MD] 89.89 mL, 95 % CI 29.76 to 150.01, 2 trials, 98 patients, p < 0.003) but no significant difference was observed for symptom scores and bladder diary parameters. TTNS was more effective than its sham-control in decreasing the number of nocturia episodes (MD -1.40, 95 % CI -2.39 to -0.42, 2 trials, 53 patients, p < 0.005) but no significant changes of OAB symptom scores were reported. PFMT was more effective than conservative advice in decreasing the ICIQ symptom score (MD, -1.12, 95 % CI -2.13 to -0.11, 2 trials, 91 patients, p = 0.03), although the number of incontinence episodes was not significantly different between groups.. The results of the meta-analysis demonstrate a moderate efficacy of all considered treatments without proving the superiority of one therapy over the others. Combination treatment using different pharmacological and non-pharmacological therapies could achieve the best clinical efficacy due to the favorable combination of the different mechanisms of action. This could be associated with fewer side effects due to drug dosage reduction. These data are only provisional and should be considered with caution, due to the few studies included in metaanalysis and to the small number of patients.

Topics: Cholinergic Antagonists; Humans; Nocturia; Pelvic Floor; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence

Topics: Acetanilides; Humans; Thiazoles; Urinary Bladder, Neurogenic

To evaluate the use of mirabegron in patients with neurogenic bladder.. A systematic review of the literature was conducted using four databases (Medline via PubMed, Scopus, Cochrane, and EMBASE). Articles evaluating mirabegron in neurogenic bladder patients were collected, and assessment of the drug's efficacy was reviewed according to clinical and urodynamic parameters.. Seven studies were selected and a total of 302 patients with NB were evaluated, ranging from 15 to 66 patients per study. All of the patients had received antimuscarinics as a previous treatment modality. Mirabegron was used as a second-line treatment after antimuscarinics lacked efficacy or caused adverse effects. The duration of the treatments ranged from 4 to 12 weeks. Reported in two studies each, bladder compliance and maximal cystometric capacity were the most commonly improved urodynamic parameters. In the majority of the studies, positive outcomes were reported for clinical scores. Additionally, analysis of the IPSS subscores revealed an improvement of storage symptoms as opposed to voiding symptoms. In all of the studies, mirabegron was well tolerated.. Mirabegron appears to be an effective treatment in the management of neurogenic bladder unresponsive to antimuscarinics, particularly in patients presenting with storage symptoms. There is still no evidence concerning the use of mirabegron as a first-line therapy for neurogenic bladder.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Humans; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic

This review aims to update the studies involving the treatment of lower urinary tract symptoms (LUTS) in neurogenic patients, published in the last two years.. Treatment of neurogenic LUTS (NLUTS) patients with β3 adrenoreceptor agonists was investigated in real-life conditions. A randomized controlled trial compared the efficacy of antimuscarinics versus onabotulinum toxin A in neurogenic patients. The use of desmopressin to treat nocturia in multiple sclerosis patients is also reported. The long-term treatment with BontA efficacy, its discontinuation, and possible strategies to maintain patients on treatment were also evaluated. Sacral neuromodulation and tibial nerve stimulation are continuously being evaluated in neurogenic patients, especially in the last years.. The management of urinary tract infections and vesical lithiasis, two common complications in NLUTS patients, and the management of both these patients was assessed in clinical trials.A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Botulinum Toxins, Type A; Humans; Lower Urinary Tract Symptoms; Muscarinic Antagonists; Nocturia; Thiazoles; Urinary Bladder, Neurogenic; Urological Agents

Overactive bladder (OAB) is a common and bothersome condition manifested by urgency, frequent urination, significantly impairing patients quality of life. The article presents an overview of the evidence on pharmacotherapy of neurogenic and idiopathic OAB. Selective M3 receptor blockers have been shown to be the medications of choice in treating these patients. Many studies have shown that solifenacin 10 mg is a starting dose for patients with OAB. Mirabegron (Betmiga) is the only 3-adrenergic receptor agonist approved for primary treatment of OAB patients refractory to anticholinergics or have their side effects. It seems promising to use this drug, both as monotherapy and concurrently with anticholinergic agents to improve treatment results in patients with idiopathic and neurogenic OAB.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Drug Combinations; Humans; Muscarinic Antagonists; Randomized Controlled Trials as Topic; Solifenacin Succinate; Sulfonamides; Tamsulosin; Thiazoles; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive

Currently, a wide range of different drugs is available for te management of overactive bladder. This creates problems when it comes to drug selection and personalized care for each patient. Mirabegron is the only 3-adrenomimetic agent for the treatment of urinary disorders, which, after careful long-term multi-center randomized trials, has been approved for use in Europe and North America. Mirabegron has proven to be very effective in patients who had previously received anticholinergic drugs and discontinued them because of the insufficient therapeutic effect or pronounced adverse reactions. However, the question of using Mirabegron as a first-line treatment for overactive bladder and the existing limitations in its administration in clinical urology practice remains open.

Topics: Acetanilides; Female; Humans; Male; Thiazoles; Urinary Bladder, Neurogenic; Urinary Incontinence

Topics: Acetanilides; Administration, Intravesical; Aged; Behavior Therapy; Botulinum Toxins, Type A; Cholinergic Antagonists; Combined Modality Therapy; Cooperative Behavior; Female; Humans; Interdisciplinary Communication; Male; Thiazoles; Urinary Bladder; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence

Patients with spinal cord injury (SCI) present with a wide range and variety of urologic manifestations, depending upon the level of injury. Historically, patients with spinal cord injury experienced significant mortality related to renal failure. Greater knowledge of the pathophysiology of SCI, however, has contributed to a reduction in mortality. It is essential to perform a thorough initial evaluation and regular follow-up of these patients to achieve the primary goal of preservation of renal function, with the secondary goal of optimizing the patient's quality of life.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Botulinum Toxins, Type A; Catheters, Indwelling; Humans; Muscarinic Antagonists; Neuromuscular Agents; Plastic Surgery Procedures; Spinal Cord Injuries; Thiazoles; Urethra; Urinary Bladder; Urinary Bladder, Neurogenic; Urinary Catheterization; Urinary Diversion; Urodynamics

Overactive bladder (OAB) is defined by its hallmark symptom, urgency. It can be associated with urge urinary incontinence (UUI), and dramatically impact the patients' quality of life. Etiologies of OAB are numerous, and under this common wording, virtually all the population is covered (men as well as women, patients with or without neurogenic disease, and all age categories). OAB and UUI management have been historically based on non-interventional therapies, antimuscarinics, and surgery. In the last decade, innovations in the treatment of this highly prevalent condition have been multiple, and further insights came from various horizons (drug invention, innovative use of existing drugs, new medical devices, tissue engineering, gene and cell therapy). Notably, the use of BoNT and neuromodulation techniques have deeply modified the algorithm of specialized OAB management, delaying surgery indications and offering mini-invasive alternatives to patient refractory to behavioral and medical treatment. Whilst some of these techniques are about to reach maturity, numerous questions remain unsolved about their indications, long term effects, rank in the armamentarium, cost-effectiveness, hypothetical combination or sequential use. The present review depicts the actual wide range of options available for OAB management in adults, focusing on the latest evolutions. When relevant, a distinction was made between genders and OAB subtypes (idiopathic vs neurogenic) regarding treatment outcomes.

Topics: Acetanilides; Botulinum Toxins, Type A; Caffeine; Clinical Trials, Phase III as Topic; Drinking Behavior; Electric Stimulation Therapy; Electrodes, Implanted; Exercise Therapy; Female; Humans; Male; Multicenter Studies as Topic; Muscarinic Antagonists; Neurokinin-1 Receptor Antagonists; Pelvic Floor Disorders; Phosphodiesterase Inhibitors; Randomized Controlled Trials as Topic; Therapies, Investigational; Thiazoles; Urinary Bladder Neck Obstruction; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urologic Surgical Procedures

To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction.. Randomized, double-blind, placebo-controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P-value <0.05 was considered significant.. Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.

Topics: Acetanilides; Adult; Aged; Canada; Double-Blind Method; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Pilot Projects; Spinal Cord Injuries; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence; Urodynamics

Mirabegron is a beta-3 adrenergic receptor agonist that received FDA approval in 2021 to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. Despite its safety and efficacy, access to mirabegron frequently remains restricted by payor coverage policies.. This cost minimization study sought to determine the cost implications from a payor perspective of mirabegron use at different points in the treatment pathway for pediatric NDO.. A Markov decision analytic model was constructed to assess the costs for eight treatment strategies over a 10-year period, using six-month cycles (Table). Five strategies involve mirabegron use as first-, second-, third-, or fourth-line therapy. Two strategies, including the "base case," entail use of anticholinergic medications followed by onabotulinum toxin type A (Botox) injection and augmentation cystoplasty. A strategy involving first-line Botox was also modeled. The effectiveness, adverse event rates, attrition rates, and costs associated with each treatment option were obtained from the clinical literature and adjusted to a six-month cycle. Costs were adjusted to 2021-dollar value. A discount rate of 3% was used. To quantify uncertainty, costs and treatment transition probabilities were modeled as gamma and PERT distributions, respectively. One-way sensitivity analyses were performed. Probabilistic sensitivity analysis (PSA) was conducted using a Monte Carlo simulation with 100,000 iterations. Analyses were performed using Treeage Pro (Healthcare Version).. The least costly strategy involved first-line mirabegron (expected cost $37,954). All strategies involving mirabegron were less costly than the base case ($56,417). On PSA, first-line mirabegron was the least costly strategy in 88.9% of cases (mean $37,604, 95% CI: $37,579-37,628); in 100% of cases, the least costly strategy involved mirabegron use. Cost savings associated with mirabegron use were attributable to decreased use of augmentation cystoplasty and Botox injections.. This is the first study to compare costs across multiple strategies involving mirabegron to treat pediatric NDO. Mirabegron use likely yields cost savings for the payor: the least costly strategy involved first-line mirabegron, and all pathways incorporating mirabegron were less costly than those without mirabegron use. These findings provide an updated cost analysis for the treatment of NDO by investigating mirabegron use alongside more established treatment options.. Use of mirabegron for the treatment of pediatric NDO is likely associated with cost savings as compared to treatment pathways without mirabegron. Expansion of payor coverage for mirabegron, as well as clinical studies to study first-line mirabegron use, should be considered.

Topics: Botulinum Toxins, Type A; Child; Costs and Cost Analysis; Humans; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive

To evaluate the efficacy and safety of mirabegron in children and adolescents (aged 3 to <18 years) with neurogenic detrusor overactivity (NDO) using clean intermittent catheterization.. In this open-label, multicenter, baseline-controlled, Phase III study (NCT02751931), participants received once-daily mirabegron at an adult dose equivalent of 25 mg. Dose was increased to 50 mg equivalent unless there were safety/tolerability concerns. The primary efficacy endpoint was change from baseline to Week 24 in maximum cystometric capacity (MCC). Secondary urodynamic assessments, Pediatric Incontinence Questionnaire (PIN-Q), Patient Global Impression of Severity (PGI-S), Clinician Global Impression of Change (CGI-C), and Acceptability questionnaires were included.. Overall, 86 participants (55 aged 3 to <12 years, 31 aged 12 to <18 years) received treatment; 68 were included in efficacy assessments. A statistically significant increase in MCC from baseline to Week 24 was observed (87.20 ml, 95% confidence interval: 66.07, 108.33; p < .001); this increase was apparent from Week 4. Significant increases in bladder compliance, bladder volume until first detrusor contraction, average volume per catheterization, maximum daytime catheterized volume and number of dry days per week. Significant decreases in detrusor pressure and number of leakage episodes per day were also observed. Significant improvement in PGI-S but not PIN-Q was observed. Most participants reported their condition had either much or very much improved using the CGI-C. Mirabegron was well tolerated in this population with a profile aligned with that in adults.. Mirabegron was effective and well-tolerated in the treatment of pediatric patients with NDO.

Topics: Acetanilides; Adolescent; Adult; Child; Humans; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urodynamics

Mirabegron, a selective β3-adrenoreceptor agonist, is a well-established alternative to antimuscarinics in adults with overactive bladder (OAB) symptoms and is under development for use in pediatric patients. Understanding drug pharmacokinetics (PK) in pediatric patients is needed to determine appropriate dosing. Conducting these studies is ethically complex, particularly as regulatory guidance requires that PK is assessed in pediatric patients with a therapeutic need for the drug. It is also vital to evaluate the safety/tolerability and palatability/acceptability of pediatric formulations.. The purpose of the study was to characterize the PK of mirabegron in pediatric patients with neurogenic detrusor overactivity or idiopathic OAB, to provide a basis for a weight-based dosing algorithm, and to evaluate the safety, tolerability, and palatability/acceptability of the formulations.. A preliminary population PK model constructed from adult data with allometric scaling was used to predict single weight-adjusted mirabegron doses. This was developed to achieve exposures in pediatric patients in two phase 1 studies that were consistent with steady state in adults following once-daily 25 mg ('low dose') and 50 mg ('high dose') dosing. In study 1, adolescents (12-<18 years) and children (5-<12 years) received a single tablet under fed or fasted conditions. In study 2, children (3-<12 years) received a single oral suspension dose under fed conditions. The PK data were used to assess the predictive value of the preliminary PK model and to update it to analyze mirabegron PK in pediatric patients. The safety/tolerability and palatability/acceptability of the formulations were evaluated.. Forty-three patients comprised six study cohorts: adolescents, low-dose tablets, fed (n = 7); children, low-dose tablets, fed (n = 7); adolescents, high-dose tablets, fed (n = 8); children, high-dose tablets, fed (n = 6); children, high-dose tablets, fasted (n = 6); and children, high-dose oral suspension, fed (n = 9). The population PK model-based doses for tablets and oral suspension achieved exposures that were typically consistent with steady state in adults. The final population PK model was used to describe the PK for mirabegron in pediatric patients (Table). Both formulations were well tolerated, and there were no reports of bad taste or swallowing difficulties for the tablets, although some found the oral suspension unpleasant.. The single, weight-adjusted pediatric mirabegron doses were successfully predicted by population PK modeling to achieve drug exposures comparable with steady state in adults. The finalized PK model used to characterize the pediatric PK of mirabegron will be utilized to develop a weight-based dosing algorithm. The single mirabegron doses were well tolerated.

Topics: Acetanilides; Adolescent; Adrenergic beta-3 Receptor Agonists; Child; Child, Preschool; Cohort Studies; Female; Humans; Male; Thiazoles; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive

When patients with neurogenic bladder become refractory, there are different alternatives, such as the use of β3-adreceptor agonists. The aim of the present study is to evaluate efficacy and safety of Mirabegron as adjuvant treatment.. 37 patients under 18 years of age who underwent Mirabegron were retrospectively studied. The inclusion criteria were: cases with neurogenic bladder who were under clean intermittent catheterization (CIC) programs and refractory to oral oxybutynin (Group A) and/or onabotulinumtoxinA (Group B). Once refractory neurogenic bladder was confirmed by clinical and/or urodynamic studies, Mirabegron 25 mg/day was indicated and evaluation was performed in the third month without stopping therapy. Systolic/diastolic blood pressure and transaminases were monitored. Paired t test and Pearson's chi - squared test were used.. Maximum cystometric capacity increased significantly by 125 mL, from 322 to 446 ml (p < 0.0001). End-filling detrusor pressure decreased significantly by 12 cm H. In our study the treatment with Mirabegron improved significantly the clinical and urodynamic parameters. A significant increase in bladder capacity and a significant decrease in end-filling detrusor pressure were observed in both groups. The intensity of overactivity was attenuated. According to the records of the voiding diary, over 70% of the incontinent patients became dry after the administration of Mirabegron. We did not observe any adverse effects. The most important limitations of the present study are its retrospective design, the small size of the sample population and of each group, and the use of only one dose of Mirabegron.. Mirabegron as adjuvant treatment in children with refractory neurogenic bladder increased bladder capacity, reduced intravesical pressure and helped achieve continence in more than two thirds of the sample population. Mirabegron was safe and well tolerated by children.

Topics: Acetanilides; Adolescent; Child; Humans; Retrospective Studies; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urodynamics

Antimuscarinics are the first pharmacological treatment option for neurogenic bladder in children with spina bifida but side effects limit their use. Mirabegron, a new β-3 adrenoceptor agonist with a distinct mechanism of action, is a potential agent for the treatment of neurogenic bladder; however, it has yet to be studied in the pediatric population. This study evaluated the efficacy and safety of mirabegron for treating neurogenic bladder in children with spina bifida.. Clinical and urodynamic parameters were retrospectively studied in 66 children (under 18 years of age) with spina bifida who were treated for neurogenic bladder with mirabegron at Severance Children's Hospital between July 2015 and December 2017. Pediatric patients received 50 mg mirabegron daily for at least 6 weeks either in addition to or instead of antimuscarinic therapy. Urodynamic parameters, including compliance, involuntary detrusor contraction, and maximum cystometric capacity, as well as patient-reported efficacy and adverse events, were measured.. In both groups post-treatment, incontinence significantly improved. In addition, maximum cystometric capacity and compliance significantly increased post-treatment. Six patients reported side effects (constipation, 4.5%; headache, 3.0%; and hypertension, 1.5%) and three patients discontinued treatment.. We evaluated the efficacy and safety of mirabegron for treating neurogenic bladder in pediatric patients with spina bifida. All clinical and urodynamic parameters improved with treatment. Prospective, placebo-controlled studies are necessary to confirm these findings.

Topics: Acetanilides; Adolescent; Adrenergic beta-3 Receptor Agonists; Child; Child, Preschool; Female; Humans; Male; Pilot Projects; Retrospective Studies; Spinal Dysraphism; Thiazoles; Treatment Outcome; Urinary Bladder, Neurogenic

To determine factors for treatment persistence in a real-life cohort of adult neurogenic lower urinary tract dysfunction.. We reviewed records of patients with neurogenic lower urinary tract dysfunction and mirabegron prescriptions. Exclusion criteria were indwelling urethral or suprapubic catheters and implanted neurostimulators. We extracted demographic data, indication for prescription, concomitant use of other agents with possible anticholinergic effect, beta blockers, duration of treatment and reason of discontinuation.. We included 110 subjects in this study. Neurologic diagnoses included multiple sclerosis, Parkinson's disease, and other diagnoses (dementia, paraplegia, and tetraplegia). Previous usage of antimuscarinics was found in 78 patients (71%). Mirabegron was combined with antimuscarinics in 15 patients (14%). Drugs with any anticholinergic activity were taken by 94 subjects (86%). Mirabegron was taken for a median of 497 days and 60 patients discontinued the medication within the study period. Main reasons of discontinuation were lack of effect (44/110), side effects (10/110), and non-reimbursement (6/110). There were no differences in mirabegron discontinuation by neurological disease, beta blocker usage, or anticholinergic burden.. Mirabegron is continued in more than half of patients with neurogenic lower urinary tract dysfunction for more than 6 months. Further research is needed to identify eventual predictive factors.

Topics: Acetanilides; Adult; Aged; Female; Humans; Male; Middle Aged; Retrospective Studies; Thiazoles; Urinary Bladder, Neurogenic; Urological Agents

Multiple sclerosis (MS) is the commonest progressive neurological disease affecting young people. With advancing disease, management of neurogenic detrusor overactivity (NDO) based on antimuscarinics may prove inadequate and if based on botulinum toxin, may necessitate clean intermittent self-catheterization. The aim of the study was to evaluate the effectiveness of combined mirabegron and desmopressin administration in the treatment of NDO in patients with MS.. Sixty patients diagnosed with MS and NDO were evaluated. All had received treatment with solifenacin 10 mg/daily for 3 months and were displeased with the results. Patients were divided in four groups. In Group A (n = 15) patients continued receiving solifenacin 10 mg/daily; in Group B (n = 15) patients received mirabegron 50 mg/daily; in Group C (n = 15) patients received desmopressin 120 mcg/daily and in Group D (n = 15) patients received mirabegron 50 mg/daily and desmopressin 120 mcg/daily. All patients were assessed with a 3 day bladder diary at the beginning and at the end of the treatment.. All patients in Groups A, B and C did not demonstrate statistically significant changes at the end of the treatment period in their 3 day bladder diary and in the presence of urinary infections. In Group D, a statistically significant improvement was noted in the mean change from baseline to end of treatment in micturition episodes (3.5 +/- 0.4 micturition/24h), in urgency episodes (2.3 +/- 0.2) and mean number of urinary incontinence (1.0 +/- 0.2 episodes/24h).. Treatment with mirabegron and desmopressin revealed both effectiveness and safety in patients with NDO and MS.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Adult; Antidiuretic Agents; Deamino Arginine Vasopressin; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Muscarinic Antagonists; Retreatment; Solifenacin Succinate; Thiazoles; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence; Urination

To investigate the effects of combined therapy with an anticholinergic agent and a β3-adrenoceptor agonist on bladder dysfunction and proliferation-related molecule expression in rats with spinal cord injury (SCI).. The spinal cord was transected at the level of T8-9 in female Sprague-Dawley rats, which were divided into four groups; A: Vehicle, B: 10 mg/kg/day of oxybutynin, C: 10 mg/kg/day of mirabegron, and D: combined administration of oxybutynin and mirabegron. Drugs were administered by oral gavage from 2 to 4 weeks after spinal cord transection. We evaluated urodynamic parameters and bladder tissue remodeling factors.. Non-voiding contractions (NVCs) during the storage phase of cystometrograms tended to be decreased in all three treated groups with a significant reduction in group D versus A. Bladder compliance was improved, and intercontraction intervals, voided volume and bladder capacity were increased in group D. In all three treated groups (B-D), the expression of HIF1-α and TGF-β1 was decreased compared to group A. The expression of collagen-III and bFGF was decreased in groups B and D. The total bladder elastin level was increased in group D.. The combination therapy of an anticholinergic agent and a β3-adrenoceptor agonist elevated the bladder elastin level, reduced NVCs, and increased bladder compliance more effectively than the monotherapy in SCI rats. Thus, the combination therapy could be effective for the treatment of neurogenic bladder dysfunction including bladder remodeling. Neurourol. Urodynam. 36:1039-1045, 2017. © 2016 Wiley Periodicals, Inc.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Animals; Disease Models, Animal; Drug Therapy, Combination; Female; Mandelic Acids; Muscarinic Antagonists; Rats; Rats, Sprague-Dawley; Spinal Cord Injuries; Thiazoles; Urinary Bladder; Urinary Bladder, Neurogenic; Urination; Urodynamics; Urological Agents

Using a videourodynamic study, we examined the efficacy of combination therapy with mirabegron for anticholinergic-resistant neurogenic bladder. We retrospectively studied 7 patients with neurogenic bladder (5 males and 2 females) who had detrusor overactivity (DO) or low compliance bladder (＜10 ml/cmH2O) despite taking anticholinergic medication. Bladder deformity was categorized from G0 to G3 by Ogawa's classification. Mean age of study patients was 51 years (25-76). Underlying diseases were spinal cord injury in 3 patients, spina bifida in 2, spinal cord infarction in 1, and post-radical hysterectomy in 1. Preceding anticholinergic medication was solifenacin 5 mg in 1 patient, solifenacin 10 mg in 5, and tolterodine 4 mg in 1. Before mirabegron, bladder deformity was G1 in 4 patients, G2 in 1 and G3 in 2, and vesicoureteral reflux (VUR) was detected in 3 patients. Five and 4 patients had detrusor overactivity and low compliance bladder, respectively. Videourodynamic study was reevaluated at a mean of 7 months (2- 12 months) after mirabegron. After mirabegron, urinary incontinence was improved in all patients. G3 bladder deformity was improved to G2 and G1 in one patient each, and VUR disappeared in all 3 patients. DO disappeared in 2 of the 5 patients, and bladder compliance was improved in all 4 patients with low compliance bladder. In conclusion, combination therapy of mirabegron is effective and beneficial for anticholinergic-resistant neurogenic bladder.

Topics: Acetanilides; Adult; Aged; Cholinergic Antagonists; Diagnostic Imaging; Drug Resistance; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Radiography; Retrospective Studies; Spinal Cord Diseases; Thiazoles; Treatment Outcome; Urinary Bladder; Urinary Bladder, Neurogenic; Urodynamics