PURPOSE: To assess the safety and effectiveness of mirabegron in patients with PD complaining of overactive bladder (OAB).
PATIENTS AND METHODS: From January 2017 to November 2020, we performed a prospective randomized, double-blind, placebo-controlled trial that enrolled PD patients with symptoms of OAB. The total duration of the study was 13 weeks, comprising a 1-week screening period and a 12-week treatment period. A total of 110 patients were randomized in one of two groups: treatment group (mirabegron 50 mg) or placebo group. The primary outcomes of our study were the change from baseline in OAB symptom score (OABSS) and the overactive bladder questionnaire short form (OAB-q SF) score. The secondary outcomes were the change from baseline in the mean number of micturitions/24 hours, the mean number of urgency episodes/24 hours, the mean number of urgency incontinence episodes/24 hours and the mean number of nocturia episodes/night, volume voided/micturition (ml) as recorded on a 3-day bladder diary. Safety assessments included adverse events, electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and blood pressure and pulse rate measurements.
RESULTS: There was a significant improvement in the primary outcome and secondary outcome measures in the treatment group compared to the placebo group. Adverse events were mild and the same in the two groups. The cardiovascular safety profile was high. This study is limited by its sample size and its short follow-up period.
CONCLUSIONS: Mirabegron is a promising drug to control OAB symptoms in patients with PD with an excellent safety profile.
BACKGROUND: For patients with neurogenic detrusor overactivity incontinence (NDOI), treatment with oral medications is often unsatisfactory.
OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA (aboBoNT-A) for NDOI.
DESIGN, SETTING, AND PARTICIPANTS: Two randomized, double-blind phase 3 studies (CONTENT1, NCT02660138; CONTENT2, NCT02660359) enrolled patients with NDOI who were regularly performing clean intermittent catheterization (CIC) and were inadequately managed with oral therapy. Pooled results from the first placebo-controlled treatment cycle are reported.
INTERVENTION: Patients received injections of aboBoNT-A 600 U (n = 162) or 800 U (n = 161) or placebo (n = 162) into the detrusor muscle.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the mean change from baseline in NDOI episodes per week at week 6. Secondary endpoints reported are the proportion of patients with no NDOI episodes, the volume per void, urodynamic parameters, and quality of life (QoL). Safety was also assessed. Statistical analyses were conducted for the pooled study populations (each aboBoNT-A dose vs placebo).
RESULTS AND LIMITATIONS: At week 6, NDOI episodes per week were significantly reduced in each aboBoNT-A group versus placebo (both p < 0.001) and the volume per void had significantly increased. Approximately one-third of patients in each aboBoNT-A dose group reported no NDOI episodes versus 3% of patients in the placebo group. Reductions in urinary incontinence (UI) were reflected in significantly greater improvements in UI-related QoL in the aboBoNT-A groups versus placebo. Urodynamic parameters (bladder capacity and detrusor pressure) were significantly improved with each aboBoNT-A dose versus placebo. Each aboBoNT-A dose was well tolerated. Symptomatic urinary tract infection was the most frequent treatment-emergent adverse event, with incidence comparable across the aboBoNT-A and placebo groups. The studies were terminated prematurely owing to slow recruitment and were not designed for statistical comparison between the two aboBoNT-A doses.
CONCLUSIONS: Intradetrusor aboBoNT-A is an effective treatment and alternative option for patients with NDOI who have an inadequate response to oral anticholinergics and are already performing CIC.
PATIENT SUMMARY: In patients with bladder muscle overactivity caused by neurological conditions (multiple sclerosis or spinal cord injury) and resulting in urinary incontinence, abobotulinumtoxinA injections improved their symptoms and bladder function, with no unexpected effects.
Objective : The aim of the study was to investigate the therapeutic effect of transcutaneous electrical nerve stimulation on neurogenic overactive bladder that is refractory to pharmacotherapy. Methods : This randomized trial recruited 83 participants with neurogenic overactive bladder that were nonresponsive to 3-mo first-line anticholinergic drug treatment. Participants were randomized into treatment and control groups. Transcutaneous electrical nerve stimulation current consisting of biphasic square wave with pulse durations of 150 [mu]s and pulse frequency set at 20 Hz were applied to for 30 mins once a day for 90 days. Stimulation was provided over the lateral aspect of the sacrum bilaterally of the electrodes. Patients in the transcutaneous electrical nerve stimulation group stopped taking the anticholinergic drugs. The control group continued to receive anticholinergic drugs for 90 days. The participants' Overactive Bladder Symptom Score, the Medical Outcomes Study 36-Item Short-Form Health Survey scores, urodynamic values, and voiding diary data were assessed before and after the therapy. Results : The transcutaneous electrical nerve stimulation treatment group had significantly decreased Overactive Bladder Symptom scores compared with the control group (P < 0.001); in addition, half of the Medical Outcomes Study 36-Item Short-Form Health Survey scores were significantly improved in the transcutaneous electrical nerve stimulation group (P < 0.05). The patients treated with transcutaneous electrical nerve stimulation improved significantly voiding diary parameters at P < 0.05. Similarly, urodynamic values at P < 0.05 favored the experimental group over the control group. CONCLUSIONS: Applying daily transcutaneous electrical nerve stimulation over the sacral region for 90 days to patient with neurogenic overactive bladder improved overactive bladder symptoms of patients whose response to anticholinergic drugs is far inferior. To Claim CME Credits: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) Determine the therapeutic effect of transcutaneous electrical nerve stimulation (TENS) on neurogenic overactive bladder (NOAB); (2) Demonstrate the effectiveness of reflex suppression of the bladder using the TENS applied over the sacral region as a stimulation location; and (3) Confirm the TENS method using biphasic square waves with pulse durations of 150 [mu]s and pulse frequencies of 20 Hz as applied is shown to be superior to anticholinergic drugs in managing NOAB. Level: Advanced Accreditation: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Association of Academic Physiatrists designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) (TM). Physicians should only claim credit commensurate with the extent of their participation in the activity.
OBJECTIVES: To evaluate the neurological safety and clinical efficacy of darifenacin and mirabegron in patients with a history of cerebrovascular accident (CVA) who had overactive bladder (OAB) symptoms.
METHODS: This prospective randomized study, approved by the institute's ethics committee, was carried out at a tertiary care center from December 2018 to June 2020. Treatment naïve adult patients with a past history of CVA with stable neurological status for atleast past 3 months with symptoms of OAB for 3 or more months were included. Eligible patients received either darifenacin or mirabegron for a period of 3 months and various parameters on the 3-day International Consultation on Incontinence Questionnaire (ICIQ) bladder diary, the Montreal Cognitive Assessment-Basic score (MoCA-B), and the adverse events at 3 months posttreatment were compared to that at the baseline.
RESULTS: A total of 60 patients were included, 30 in each arm. After 3 months of treatment with darifenacin or mirabegron, the majority of the ICIQ bladder diary parameters improved and there was no deterioration in the cognitive function as noted on the MoCA-B score in either of the arms. On intergroup comparison, the mean change in bladder diary parameters and the MoCA-B scores was similar between the two groups.
CONCLUSION: Darifenacin and mirabegron, in the short term, do not adversely affect the cognitive function in patients with a history of CVA with OAB symptoms. Both are safe and effective treatment options in patients with OAB post-CVA.
BACKGROUND: Although acupuncture has been shown to be effective at treating overactive bladder (OAB) following stroke, to our knowledge, no randomized controlled trial (RCT) examining the effects of acupuncture on patients with post-stroke OAB has been conducted. The aim of this preliminary study was to explore the effects of electroacupuncture (EA) in the treatment of post-stroke OAB. METHODS: This study was a multi-site randomized, assessor-blind, controlled pilot trial of patients with post-stroke OAB. In all, 34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms were randomly assigned to the treatment group or control group in a 1:1 ratio. The subjects in the treatment group were treated with six sessions of EA for 4 weeks, while the subjects in the control group received usual care. The primary outcome measure was the overactive bladder symptom scale (OABSS). Secondary outcome measures included a three day bladder diary and the stroke-specific quality-of-life scale (SSQoL). RESULTS: EA showed a moderate effect size (ES) on the perceived severity of OAB symptoms as measured by the OABSS at week 5 (one week post-treatment, ES 0.57; p = 0.034) and week 8 (three weeks post-treatment, ES 0.60; p = 0.021), although the results did not remain statistically significant after Bonferroni correction for multiple testing. No significant differences in bladder diary parameters or SSQoL score were found. The EA treatment was well tolerated by the post-stroke subjects. CONCLUSION: A six-session EA treatment was feasible and appeared to reduce OAB symptoms in post-stroke patients. Further fully powered trials are warranted to confirm the efficacy of EA for those with post-stroke OAB.
Objective: To assess the efficacy and safety of botulinum toxin treatment (onabotulinumtoxinA 200 units) for Japanese patients with neurogenic detrusor overactivity caused by spinal cord injury or multiple sclerosis. Methods: Patients with urinary incontinence refractory to pharmacological treatment were enrolled and randomized in a phase III trial. A single dose of onabotulinumtoxinA (n = 11) or placebo (n = 10) was given in the double‐blind phase, and repeat injections of onabotulinumtoxinA were given in the subsequent open‐label phase. Outcomes included urinary incontinence episodes, urodynamics, patient‐reported outcomes and adverse events. Results: The onabotulinumtoxinA group showed a numerically greater reduction in the number of urinary incontinence episodes per day than the placebo group, with the difference between the groups at week 6 of −3.02 (95% confidence interval −5.85 to −0.19). The onabotulinumtoxinA group also showed greater improvements in urodynamic assessments. Adverse events related to onabotulinumtoxinA injections were hematuria, urinary retention, urinary bladder hemorrhage, autonomic dysreflexia and epididymitis. Most events were deemed mild or moderate. Conclusions: Intradetrusor injections of onabotulinumtoxinA are efficacious and tolerable for Japanese patients with neurogenic detrusor overactivity‐related symptoms that are difficult to manage with anticholinergics and/or β3‐adrenergic receptor agonists.
AIMS: This study aims to investigate the efficacy of transcutaneous tibial nerve home stimulation for overactive bladder (OAB) in women with Parkinson's disease (PD).
METHODS: The current study is a prospective, randomized, double-blind, sham-controlled trial. Home intervention was carried out and assessments were conducted at a tertiary hospital in South Brazil. Women with PD and OAB symptoms were included in the study. Patients were randomly divided into two groups: (1) stimulation and (2) sham. Both groups underwent intervention at home for 12 weeks. Patients were evaluated at baseline and at 12 weeks (end of intervention), 30- and 90-day follow-up. The primary outcome was the mean reduction in the number of urgency incontinence episodes, and secondary outcomes included daytime and nighttime urinary frequency, urinary urgency episodes, use of pad (reported in a 24-h bladder diary), OAB-V8 and King's Health Questionnaire scores, and maintenance of symptom relief after discontinuation of the intervention.
RESULTS: In total, 30 consecutive patients completed the study (15/group). The stimulation group showed a reduction in nighttime urinary frequency (0.9 ± 0.6), urinary urgency (1.0 ± 1.2), urgency incontinence episodes (0.5 ± 0.6), use of pads (1.3 ± 1.2), and OAB-V8 (1.3 ± 1.2) and King's Health Questionnaire scores. In a 30-day and 90-day follow-up, 8 (53.3%) and 5 (33.3%) stimulation patients, respectively, reported full maintenance of symptom relief after discontinuation of the intervention. Stimulation patients presented a statistically significant improvement of symptoms as compared with sham patients (p = .001).
CONCLUSIONS: Transcutaneous tibial nerve home stimulation can be used in clinical practice as an effective nonpharmacological resource for the reduction of OAB symptoms in women with PD, and the resulting relief seems to persist in the follow-up (30 and 90 days).
AIMS: This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo-controlled, multicenter study.
MATERIALS AND METHODS: Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2-week wash-out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4.
RESULT: The mean age was 68.1 ± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication-related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups.
CONCLUSION: Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.
<b>OBJECTIVE: </b>To assess the feasibility and efficacy of bladder training for troublesome lower urinary tract symptoms (LUTS) in Parkinson disease (PD).<b>METHODS: </b>In this single-center, single-blinded, randomized controlled trial, participants with a history of PD and LUTS were randomized to a 12-week bladder training program (BT) or conservative advice (CA). Outcome measures included a 3-day volume frequency diary, International Consultation on Incontinence Questionnaire (ICIQ)-Overactive Bladder Module, and ICIQ-Quality of Life Module. Co-primary endpoints were (1) patient perception of change and (2) change in number of urgency episodes at 12 weeks. Secondary endpoints included change in ICIQ scores, number of micturitions, and volume voided.<b>RESULTS: </b>Thirty-eight participants were randomized (18 to CA, 20 to BT). Both CA and BT were associated with significant improvements in volume voided, number of micturitions, symptom severity scores, and measures of quality of life (all p < 0.05). At 12 weeks, compared to CA, BT was associated with significant superiority on patient perception of improvement (p = 0.001), significantly greater reductions in number of voids in 24 hours (mean decrease 2.3 ± 0.8 voids vs 0.3 ± 0.5 [p < 0.05]), and greater reductions in interference with daily life (2.1 ± 0.8 point improvement vs 0.3 ± 0.7 point deterioration [p < 0.05]). BT was not associated with change in urgency episodes (mean change 2.4 ± 1.5 urgency episodes vs 3.5 ± 1.5 [p NS]). At 20 weeks, BT remained associated with greater improvement in interference in daily life. Loss of significance in other measures may reflect loss of power from loss to follow-up.<b>CONCLUSION: </b>This controlled trial demonstrated the potential benefits of BT for LUTS in PD.<b>Classification Of Evidence: </b>This study provides Class III evidence that for patients with PD and LUTS, BT significantly increased patient perception of improvement but did not significantly reduce urgency episodes.
To assess the safety and effectiveness of mirabegron in patients with PD complaining of overactive bladder (OAB).
PATIENTS AND METHODS:
From January 2017 to November 2020, we performed a prospective randomized, double-blind, placebo-controlled trial that enrolled PD patients with symptoms of OAB. The total duration of the study was 13 weeks, comprising a 1-week screening period and a 12-week treatment period. A total of 110 patients were randomized in one of two groups: treatment group (mirabegron 50 mg) or placebo group. The primary outcomes of our study were the change from baseline in OAB symptom score (OABSS) and the overactive bladder questionnaire short form (OAB-q SF) score. The secondary outcomes were the change from baseline in the mean number of micturitions/24 hours, the mean number of urgency episodes/24 hours, the mean number of urgency incontinence episodes/24 hours and the mean number of nocturia episodes/night, volume voided/micturition (ml) as recorded on a 3-day bladder diary. Safety assessments included adverse events, electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and blood pressure and pulse rate measurements.
RESULTS:
There was a significant improvement in the primary outcome and secondary outcome measures in the treatment group compared to the placebo group. Adverse events were mild and the same in the two groups. The cardiovascular safety profile was high. This study is limited by its sample size and its short follow-up period.
CONCLUSIONS:
Mirabegron is a promising drug to control OAB symptoms in patients with PD with an excellent safety profile.
