Changes In Overactive Bladder Symptoms Research Articles

Plain language summary: does treatment with vibegron result in improvements in overactive bladder (OAB) symptoms that are meaningful to people with OAB?

What is this summary about? This is a plain language summary of an article published in the journal Advances in Therapy. In 2020, the US Food and Drug Administration (also called the FDA) approved a medicine called vibegron to treat overactive bladder, also called OAB. The key results used to approve vibegron were from the EMPOWUR study. In the EMPOWUR study, participants who took vibegron had fewer urination episodes, urgency episodes, and bladder leaks each day than those who took a pill containing no medicine, called a placebo. At the end of the study, participants also rated how much their overactive bladder symptoms changed overall during EMPOWUR by responding to a survey. Many participants rated their overactive bladder symptoms as improved overall. This study asked if improvements in the number of urination episodes, urgency episodes, and bladder leaks caused by urgency were associated with feeling better overall. This study also looked at how many participants in the EMPOWUR study had improvements in the number of urination episodes, urgency episodes, and bladder leaks that were big enough to matter. A separate group of people with overactive bladder were asked about the magnitude of improvements that would be important to them. This group had not participated in the EMPOWUR study. What were the results? EMPOWUR participants who reported that taking medicine resulted in their overactive bladder symptoms getting better overall also generally reported fewer daily urinations, urgency episodes, and bladder leaks after treatment. Many had changes in their symptoms that were meaningful. Meaningful was defined for each symptom as: at least 15% fewer urinations, 50% fewer urgency episodes, and 75% fewer bladder leaks. Participants who received vibegron had meaningful reductions in the daily number of episodes of urination, urgency, and bladder leaks more often than those who received the placebo (pill with no active medicine). People with overactive bladder who did not participate in the study were interviewed and said that improvements to those symptoms, similar to those seen in the EMPOWUR study, would be important to them. What do the results mean? This study suggests that the results we measured in the EMPOWUR study may also reflect changes in overactive bladder symptoms that are big enough to be important to people with overactive bladder. Many participants who took vibegron in the EMPOWUR study felt that it helped to improve their individual overactive bladder symptoms. This may also help improve quality of life of participants. Clinical Trial Registration: NCT03492281 (ClinicalTrials.gov).

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder.

Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients' quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.

A Feasibility Study to Evaluate Changes in Urinary Metabolites after OnabotulinumtoxinA Injection for Refractory Overactive Bladder.

Metabolomics analysis of urine before and after overactive bladder (OAB) treatment may demonstrate a unique molecular profile, allowing predictions of responses to treatment. This feasibility study aimed to correlate changes in urinary metabolome with changes in OAB symptoms after intravesical onabotulinumtoxinA (BTX-A) injections for refractory OAB. Women 18 years or older with non-neurogenic refractory OAB were recruited to complete OAB-V8 questionnaires and submit urine samples before and after 100 units intravesical BTX-A injection. Samples were submitted to CE-TOFMS metabolomics profiling. Data were expressed as percent of change from pre-treatment and were correlated with OAB-V8 score improvement. Urinary metabolite changes in the OAB-V8 groups were compared using the Kruskal–Wallis test, and associations between metabolites and OAB-V8 scores were examined using quantile regression analysis. Of 61 urinary metabolites commonly detected before and after BTX-A, there was a statistically significant decrease in adenosine and an increase in N8-acetylspermidine and guanidinoacetic acid levels associated with OAB score improvement, suggesting that intravesical BTX-A injection modifies the urinary metabolome. These urinary metabolites could provide insight into OAB pathophysiology and help identify patients who would benefit most from chemodenervation.

Peroneal Electrical Transcutaneous NeuroModulation as a New Treatment for Patients with Overactive Bladder: An Initial Clinical Experience

Introduction: The aim of this study was to determine whether peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) using the URIS® neuromodulation system can be used in individuals with refractory overactive bladder (OAB). Methods: Eighteen female patients with idiopathic OAB who failed previous behavioral and pharmacological therapy were enrolled. Patients were treated with the URIS® neuromodulation system using active electrodes placed on the popliteal fossa, targeting the peroneal nerve for 30 min once a week for 12 weeks. Changes in OAB symptoms and patient-reported outcomes from baseline to the end of the study were analyzed. A nonparametric Wilcoxon signed-rank test was used to assess changes in variables. Statistical significance was defined as p ≤ 0.05. Results: We observed a significant reduction in micturition frequency (p = 0.022), number of severe urgency episodes (p < 0.001), urgency incontinence episodes (p = 0.001), and nocturia episodes (p = 0.027). A decrease in Patient Perception of Bladder Condition score (p < 0.001) was also observed. Posttreatment, 15 patients (83.3%) reported a moderate or significant reduction in their bladder bother. Throughout the study, two adverse events were recorded with no causal relationship to the study treatment. Discussion/Conclusions: Our study documented a significant reduction in all OAB symptoms and an improvement in all patient-reported outcomes in patients treated with peroneal eTNM® using the URIS® neuromodulation system.

Continuing posterior tibial nerve stimulation after twelve weekly sessions: a randomized controlled trial

Posterior Tibial Nerve Stimulation (PTNS) is a treatment option for refractory Overactive Bladder (OAB). There is currently no evidence to support which maintenance schedule is most effective. The objective of this study is to compare patientreported outcomes between monthly maintenance therapy and sessions scheduled Per patient request (PRN). We hypothesized that there is no difference in these measures between groups. After completing 12 sessions of PTNS, patients were randomized to monthly or PRN maintenance. Quality of life, patient satisfaction, and degree of symptom bother were assessed with validated questionnaires. Thirty six patients were randomized: 19 to monthly follow-up, and 17 to PRN follow-up. The PRN group demonstrated a significantly higher quality of life (p=0.04) with a large effect size (0.82). Over a three-month period, there was no significant difference in the average number of visits between the monthly and PRN groups, with an average of 1.79 (±1.18) and 1.24 (±1.35) visits, respectively (p=0.20). After six months of maintenance therapy, 42% of patients in the monthly group and 53% of patients in PRN group elected to continue therapy (p=0.27). There was no significant difference between the groups with regard to treatment satisfaction (p=0.62) or percent change in OAB symptoms (p=0.13). There is no difference between monthly and PRN follow-up in terms of patient satisfaction and symptom bother. However, the PRN group scored higher on the quality of life measure. PRN maintenance may optimize care for patients treating Overactive Bladder Syndrome with posterior tibial nerve stimulation.

Urodynamic evaluation of patients with localized prostate cancer before and 4\xa0months after robotic radical prostatectomy

Radical prostatectomy can alter the anatomy of the urinary bladder. We aimed to evaluate bladder function before and 4 months after radical prostatectomy using the urodynamic test and overactive bladder (OAB) symptom score. Among 70 prospectively enrolled patients, 61 patients completed the study. In the urodynamic test, bladder capacity and compliance did not change, the frequency of involuntary detrusor contraction decreased, the maximum flow rate and bladder outlet obstruction index improved, and the maximum urethral closure pressure (MUCP) deteriorated. Further evaluation of urodynamic parameters according to changes in symptoms was made. Although change in bladder compliance was correlated with changes in OAB symptoms, not the relative change of bladder compliance but the relative change in the MUCP was reliable factor when OAB symptoms were deteriorated. In general, prostatectomy did not deteriorate the condition of the detrusor; rather, change in the MUCP could be responsible for postprostatectomy OAB.

Treatment outcomes and overactive bladder symptoms after midurethral sling in female patients with or without various neurological diseases.

We investigated surgical outcomes and changes of overactive bladder (OAB) symptoms after midurethral sling in female stress urinary incontinence (SUI) patients with or without neurological disease (ND) without spinal cord injury. Patients who underwent midurethral sling for SUI between January 2009 and December 2018 were reviewed. Postoperative changes in OAB symptoms (de novo occurrence or resolution) within 1 year were compared in each preoperative symptom subset with a 1:1 matched analysis between non-neurological disease (NND) and ND group. A total of 855 patients (median follow-up: 49.8 months; mean age: 57.9 ± 9.3 years) were included. Successful SUI correction was achieved in 95.0% of NND and 93.7% of ND patients (p = .440). Among 797 patients (711 NND and 86 ND) without remnant SUI, 227 had SUI only, 198 had SUI with urgency, and 372 had mixed urinary incontinence (MUI) preoperatively. The ND patients tended to be older (62.8 ± 9.2 vs. 57.2 ± 9.0 years) and had higher proportions of diabetes (24.4% vs. 8.0%), hypertension (47.7% vs. 26.7%), and MUI (64.0% vs. 44.6%) than NND patients (p < .001, respectively). After matching age, diabetes, and hypertension, the incidence of de novo OAB was higher in ND patients (SUI only; 21.1% vs. 5.3%; p < .001) while resolution rates of urgency urinary incontinence (UUI) were similar (MUI; 57.7% vs. 53.9%; p = .414). Success rates of midurethral sling and resolution of UUI were comparable between NND and ND patients. In patients with neurological conditions, de novo OAB symptoms were more likely to develop.

One-year results with selective bladder denervation in women with refractory overactive bladder.

To report 1-year results with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB). In this prospective, international, multicenter case series, women with refractory OAB underwent a single SBD treatment of the bladder subtrigone region using temperature-controlled radiofrequency. Patients were followed for 1 year and evaluated for changes in OAB symptoms and adverse events. Among 35 women, 29 (83%) returned for 1-year follow up. Median symptom reductions based on 3-day bladder diaries were 68% for urgency urinary incontinence ( P < .001), 67% for urinary incontinence ( P < .001), 43% for urgency episodes ( P < .001), 5% for urinary frequency ( P = .19), and 33% for the total urgency and frequency score ( P < .001), with the majority of treatment benefit realized in the first month. Treatment benefit was reported in 72% of patients, the clinical success rate (≥50% reduction in urgency urinary incontinence) was 69%, and the dry rate was 10%. Statistically significant improvements occurred on Symptom Bother and Health-related Quality of Life scales on the Overactive Bladder questionnaire, and on 6 of 9 King's Health Questionnaire domains. Patients with less severe baseline symptoms had similar quality of life improvements as those with more severe baseline symptoms. Device- or procedure-related adverse events were reported in 6 (17%) patients. A single treatment with selective bladder denervation is durable for 1-year in a significant proportion of women with refractory overactive bladder.

Feasibility of using a novel non-invasive ambulatory tibial nerve stimulation device for the home-based treatment of overactive bladder symptoms.

BackgroundTo evaluate safety, acceptability and pilot efficacy of transcutaneous low-frequency tibial nerve stimulation (TNS) using a novel device as home-based neuromodulation.MethodsIn this single-centre pilot study, 48 patients with overactive bladder (OAB) (24 with neurogenic and 24 with idiopathic OAB) were randomized to use a self-applicating ambulatory skin-adhering device stimulating transcutaneously the tibial nerve at 1 Hz for 30 minutes, either once daily or once weekly, for 12 weeks. Changes in OAB symptoms and QoL were measured at baseline, weeks 4, 8, and 12 using validated scoring instruments (ICIQ-OAB and ICIQ-LUTSqol), 3-day bladder diary and a Global Response Assessment (GRA) at week 12.ResultsThirty-four patients completed the study (idiopathic n=15, neurogenic n=19). No significant adverse effects were noted. Patients found the device acceptable. Eighteen patients (53%) reported a moderate or marked improvement in symptoms from the GRA. Between baseline and week-12, ICIQ-OAB part A sub-scores improved from mean (SD) 9.3 (2.5) to 7.5 (3.1), and from 9.1 (1.9) to 5.9 (1.7) in the daily and the weekly arms, respectively. ICIQ-LUTSqol part A sub-scores improved from mean (SD) 51 (12.8) to 44.2 (13.1) and 44.9 (9.0) to 35.9 (8.8) in the daily and the weekly arms, respectively. Bladder diary mean 24-hour frequency episodes improved from 11.5 to 8.8 at week 12 for both arms.ConclusionsThis novel ambulatory transcutaneous TNS (TTNS) device is safe and acceptable for use in patients reporting OAB symptoms as a form of home-based neuromodulation. A larger study however is required to confirm clinical efficacy.

Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AimsTo report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB).MethodsFemales with refractory OAB underwent SBD of the bladder sub‐trigone region. Patients were treated using a 10‐s voltage‐controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60‐s temperature‐controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed.ResultsAmong 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (−2.5 vs −0.9; P < 0.01), urinary incontinence (−2.6 vs −0.8; P < 0.001), and total urgency and frequency score (−13 vs −7; P = 0.02); and improvements in symptom bother (−33 vs −18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device‐ or procedure‐related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%).ConclusionsThis study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60‐s RF algorithm using deeper ablations of the sub‐trigonal tissues was more effective and comparably safe to a 10‐s RF algorithm using more superficial ablations.

MP27-17 COULD DETRUSOR OVERACTIVITY PREDICT THE USE OF ANTIMUSCARINICS AFTER MID-URETHRAL SLING IN WOMEN WITH MIXED URINARY INCONTINENCE?

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Incontinence: Evaluation (Urodynamic Testing)1 Apr 2018MP27-17 COULD DETRUSOR OVERACTIVITY PREDICT THE USE OF ANTIMUSCARINICS AFTER MID-URETHRAL SLING IN WOMEN WITH MIXED URINARY INCONTINENCE? Yun-Chu Chang, Yu-Hua Fan, and Alex T.L. Lin Yun-Chu ChangYun-Chu Chang More articles by this author , Yu-Hua FanYu-Hua Fan More articles by this author , and Alex T.L. LinAlex T.L. Lin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.896AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patients with mixed urinary incontinence (MUI) suffer from components of both stress urinary incontinence (SUI) and overactive bladder (OAB). Many studies have shown that surgical management of SUI with a mid-urethral sling (MUS) may help OAB symptoms. It is important to evaluate the predictive factors of change in OAB symptoms after MUS in MUI patients. We conduct this study to evaluate whether detrusor overactivity (DO) could predict the change in OAB symptoms after MUS in women with MUI. METHODS We retrospectively recruited female patients with MUI treated with retropubic synthetic MUS between 2008 and 2015. All patients completed the questionnaires of Overactive Bladder Symptoms Score (OABSS) and Urogenital Distress Inventory (UDI-6) preoperatively. MUI was defined as clinical SUI with positive response to urgency or urge incontinence subscale of OABSS, or urge incontinence subscale of UDI-6. All patients underwent videourodynamic study prior to MUS. The primary outcome was the postoperative use of antimuscarinics defined as the prescription of antimuscarinics one month after MUS for more than one month. We evaluated the effects of DO and other potential risk factors for the primary outcome. RESULTS A total of 187 patients were included in the study, with 35 demonstrated with DO and 152 without DO. 26 patients with DO and 110 patients without DO required postoperative antimuscarinics. The mean duration of postoperative antimuscarinics was 6.2 ± 4.1 months. There was no significant difference in postoperative antimiscarinics between patients with and without DO. However, patients with lower detrusor pressure at maximum flow tended to use antimuscarinics after MUS in DO patients. Age, body mass index and the combination of pelvic organ prolapse surgery were similar between patients with and without postoperative antimuscarinics. Urgency and urge incontinence subscores of OABSS were significantly higher in patients with postoperative antimuscarinics than those without. Besides, urgency subscore of UDI-6 was significantly higher in patients requiring postoperative antimuscarinics. CONCLUSIONS DO alone could not predict the use of antimuscarinics after MUS in women with MUI. Nevertheless, DO patients with lower detrusor pressure at maximum flow have the tendency toward using postoperative antimuscarinics. MUI women with more severe baseline urgency and urge incontinence have higher possibility to use antimuscarinics after MUS. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e354 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Yun-Chu Chang More articles by this author Yu-Hua Fan More articles by this author Alex T.L. Lin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Changes in overactive bladder symptoms after sodium glucose cotransporter‐2 inhibitor administration to patients with type 2 diabetes

AbstractThe aim of this study was to investigate the changes in overactive bladder symptoms after selective sodium glucose cotransporter‐2 (SGLT2) inhibitor administration to patients with type 2 diabetes.Outpatients with type 2 diabetes who consented to participate in this study between September 2014 and August 2015 were included. Overactive bladder assessments were conducted before and one month after SGLT2 inhibitor administration using the Overactive Bladder Symptom Score (OABSS).Fifty‐eight patients were enrolled. OABSSs indicated that 17.2% of the subjects had overactive bladder. Comparison of OABSSs before and after SGLT2 inhibitor administration indicated that Q1 (daytime frequency) and total scores increased significantly. Post‐hoc analysis indicated that in the group without overactive bladder according to pre‐administration OABSSs, statistically significant increases were observed for Q1 (daytime frequency), Q3 (urgency), and total scores. Conversely, in the group with overactive bladder, there were no significant differences. The mean score for Q1 (daytime frequency) increased, whereas that for Q3 (urgency) decreased.It was concluded that SGLT2 inhibitor administration to patients with type 2 diabetes, but without overactive bladder, caused significant increases in daytime frequency but not in night‐time frequency. However, in patients with overactive bladder prior to SGLT2 inhibitor administration, blood glucose control was possible without worsening overactive bladder. Copyright © 2018 John Wiley &amp; Sons.

Improvement of overactive bladder symptoms: Is correction of the paravaginal defect in anterior vaginal wall prolapse necessary?

BackgroundTo explore the relationship between overactive bladder (OAB) symptoms and paravaginal defects (PVDs), and to identify the necessity of PVD repair by transvaginal mesh (TVM) for the treatment of OAB symptoms. MethodsA retrospective clinical study of 30 women with advanced cystocele with limited apical and posterior vaginal wall prolapse was conducted to identify any changes in OAB symptoms following a single Perigee procedure. Prolapse was assessed using the pelvic organ prolapse quantification (POP-Q) system, and paravaginal defects were identified by sonography. Complete urodynamic examination was performed prior to and one year after operation. All patients completed the overactive bladder questionnaire pre- and postoperatively for a quantitative assessment of OAB symptoms. ResultsAll patients showed a significant improvement at points Aa and Ba in the POP-Q system. The results of the administered questionnaire revealed statistically significant improvement postoperatively. The difference of OAB symptoms between the group with PVDs and that with central defects was not statistically significant (p = 0.67). Moreover, no statistically significant improvement of OAB symptoms in the group with repaired PVDs was observed postoperatively (p = 0.42). ConclusionStatistical improvements of symptoms exist after Aa and Ba points recovery as evaluated by POP-Q system regardless of PVD existence identified by sonography. Repairing PVD did not show significantly improve the severity of OAB symptoms in objective urodynamic data or subjective questionnaire data. The superiority of TVM in PVD repair to manage OAB symptoms seems not manifest.

Assessment of overactive bladder symptoms among women with successful pessary placement.

The causal association between pelvic organ prolapse (POP) and overactive bladder (OAB) symptoms is supported by several theories. The aim of this study is to assess any changes in OAB symptoms among women with POP and OAB after successful pessary placement. During the study period, all women with symptomatic POP stage II or greater and OAB symptoms were offered the solution of either a ring or a Gellhorn pessary. All patients were asked to complete a 3-day micturition/incontinence diary. Objective evaluation endpoints at baseline and at 6weeks included: change in the mean number of micturitions/24h, change in the mean volume voided per micturition/24h, and change in the number of urinary incontinence episodes. Subjective evaluation of the urgency, frequency, and nocturia symptoms was carried out using the score change of the questions 3, 5, and 2 of the International Consultation on Incontinence Questionnaire for Evaluating Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) respectively. Seventy-four women were included in the study. A statistically significant decrease (-28.3%; p<0.001) of the mean number of micturitions/24h with a significant increase (37%; p<0.001) in the mean voided volume per micturition/24h was observed. The total urine volume/24h remained unchanged. The number of urinary incontinence episodes was significantly increased 6weeks after pessary placement (p<0.001). De novo stress urinary incontinence (SUI) was reported by 16.7% of the initially stress continent women. Women with coexisting POP and OAB symptoms may experience a significant improvement in micturition frequency and in urgency and frequency symptoms after successful pessary fitting.

Safety, efficacy, and persistence of long-term mirabegron treatment for overactive bladder in the daily clinical setting: Interim (1-year) report from a Japanese post-marketing surveillance study.

To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis. Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3, 6 months, and 1 year, or at discontinuation (P < 0.001 at each time point). Kaplan-Meier treatment persistence rates were 84.8% at 3 months, 77.6% at 6 months, and 66.0% at 1 year. Treatment persistence rates were similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032). Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years.

Electrical stimulation with non-implanted electrodes for overactive bladder in adults.

Several options exist for managing overactive bladder (OAB), including electrical stimulation (ES) with non-implanted devices, conservative treatment and drugs. Electrical stimulation with non-implanted devices aims to inhibit contractions of the detrusor muscle, potentially reducing urinary frequency and urgency. To determine the effectiveness of: ES with non-implanted electrodes compared with placebo or any other active treatment for OAB; ES added to another intervention compared with the other intervention alone; different methods of ES compared with each other. We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 10 December 2014). We searched the reference lists of relevant articles and contacted specialists in the field. We imposed no language restrictions. We included randomised or quasi-randomised controlled trials of ES with non-implanted devices compared with any other treatment for OAB in adults. Eligible trials included adults with OAB with or without urgency urinary incontinence (UUI). Trials whose participants had stress urinary incontinence (SUI) were excluded. Two review authors independently screened search results, extracted data from eligible trials and assessed risk of bias, using the Cochrane Collaboration's 'Risk of bias' tool. We identified 51 eligible trials (3443 randomised participants). Thirty-three trials did not report the primary outcomes of subjective change in OAB symptoms. The majority of trials were deemed to be at low or unclear risk of selection and attrition bias and unclear risk of performance and detection bias. Lack of clarity with regard to risk of bias was largely due to poor reporting.Twenty-three trials (1654 participants) compared ES with no active treatment, placebo or sham treatment. Moderate-quality evidence indicated that OAB symptoms were more likely to improve in people receiving ES than with no active treatment, placebo or sham treatment (relative risk (RR) for no improvement 0.54, 95% confidence interval (CI) 0.47 to 0.63). Moderate-quality evidence indicated that similar numbers of people receiving ES and no active treatment, placebo or sham treatment experienced adverse effects.Eight trials (542 participants) compared ES with conservative treatment. Very low-quality evidence suggested no evidence of a difference between ES and PFMT or PFMT plus biofeedback in OAB symptoms (RR for no improvement 0.79, 95% CI 0.51 to 1.21 and 0.97, 95% CI 0.60 to 1.57 respectively). There was no evidence of a difference between ES and conservative treatment with regard to adverse effects.Sixteen trials (894 participants) compared ES with drug treatment (probanthine, tolterodine, oxybutynin, propantheline bromide, solifenacin succinate, terodiline, trospium chloride, terodiline). Moderate-quality evidence indicated that OAB symptoms were more likely to improve with ES than drug treatment (RR for no improvement 0.66, 95% CI 0.48 to 0.90). Low-quality evidence suggested a greater risk of adverse effects with oxybutynin (RR 1.26, 95% CI 1.07 to 1.49) and with tolterodine (RR 1.51, 95% CI 1.21 to 1.89) than with ES. There was insufficient evidence of a difference between ES and trospium hydrochloride (RR 0.73, 95% CI 0.43 to 1.25).Eight trials (252 participants) compared ES combined with another treatment versus the other treatment alone, two trials (48 participants) compared ES plus conservative treatment with no active treatment, placebo or sham treatment and six trials (361 participants) compared different types of ES. None of these comparisons had sufficient evidence to indicate any differences between the treatment groups in terms of OAB or adverse effects.Moderate-quality evidence suggested that ES improved OAB-related quality of life more than no active treatment, placebo or sham treatment. There was insufficient evidence of any difference between ES and any other treatment with regard to quality of life.There was insufficient evidence to determine if the benefits of ES persisted after the active treatment period stopped. Electrical stimulation appeared to be more effective than both no treatment and drug treatment for OAB. There was insufficient evidence to determine if ES was more effective than conservative treatment or which type of ES was more effective. This review underlines the need to conduct well-designed trials in this field measuring subjective outcomes and adverse effects.

Change in Overactive Bladder Symptoms After Surgery for Stress Urinary Incontinence in Women

Surgery for stress urinary incontinence (SUI) has high success rates and high levels of patient satisfaction as well as durability. However, a high proportion of patients seeking surgery for incontinence have mixed urinary incontinence (MUI) with symptoms of overactive bladder (OAB). The urgency component of OAB is a risk factor for treatment failure and reduced satisfaction. The primary aim of this study was to assess changes in OAB symptoms following incontinence surgery from 1 to 5 years postoperatively and to identify associated predictors of change from baseline. The investigators conducted a secondary analysis of previously unreported data from 3 multicenter SUI surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The main study outcome was a 70% or greater improvement in OAB symptoms from baseline measured by the Urinary Distress Inventory–Irritative subscale. The treatment effect of each surgical type over time was assessed with generalized linear models fit using 1-year and up to 5-year data. None of the trials had a control group. One year after surgery, each SUI procedure group reported significant improvement in Urinary Distress Inventory–Irritative scores (P < 0.001). Improvement in OAB symptoms were reported by most women (50%-71%). Similar improvements occurred among patients in the retropubic midurethral sling groups and those in midurethral transobturator sling groups at 1 year (65.5% vs 70.7%, respectively; odds ratio, 0.83; 95% confidence interval, 0.57–1.20; P = 0.32) and throughout the 5-year follow-up period. More women in the Burch group reported improvement in OAB symptoms at 1 year than in the fascial sling group (67.9% vs 56.6%); the odds ratio was 1.59, with a 95% confidence interval of 1.10 to 2.31, P = 0.01. This group difference at 1 year was maintained throughout the 5-year follow-up (P = 0.02). At 1 year, the proportion of patients in all groups achieving 70% or greater improvement in UI ranged from 50.0% to 64.3%. Over the 5-year study period, this proportion declined gradually to 36.5% to 54.1%, which was still a statistically significant level of improvement (P < 0.001). Potentially relevant clinical factors such as preoperative use of anticholinergics and urodynamic parameters were not predictive of postoperative improvement of OAB symptoms. Obese women were 43% less likely to experience relief from their OAB symptoms than overweight or normal-weight women. These data show that most women with stress-predominant mixed UI experience significant improvement in OAB symptoms 1 year after incontinence surgery. Although this initial improvement diminishes over time, the level of improvement at 5 years is still significant. Overactive bladder symptom improvement is blunted in obese women.

Change in Overactive Bladder Symptoms After Surgery for Stress Urinary Incontinence in Women.

To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline. This is a secondary analysis of data from three multicenter urinary incontinence (UI) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The primary outcome was improvement of 70% or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale. Surgical groups were compared within respective trials. Generalized linear models were fit using 1-year and up to 5-year data. Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery (P<.001). Most women (50-71%) reported improvement in OAB symptoms. Improvements were similar between midurethral sling groups at 1 year (65.5% compared with 70.7%, P=.32; odds ratio [OR] 0.83, 95% confidence interval [CI] 0.57-1.20 for retropubic compared with transobturator sling) and throughout the 5-year follow-up period. More women reported OAB symptom improvement after Burch compared with pubovaginal sling (67.9% compared with 56.6%, P=.01; OR 1.59, 95% CI 1.10-2.31 for Burch compared with sling); this group difference at 1 year persisted throughout the 5-year follow-up. At 1-year, 50.0-64.3% of patients reported 70% greater improvement in UI. This proportion declined to 36.5-54.1% at 5 years (P<.001). Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery. Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time. Obesity blunted symptom improvement. II.

Psychosocial factors related to the use of InterStim® for the treatment of refractory overactive bladder.

Sacral neuromodulation is a well-established treatment of refractory overactive bladder (OAB). Although literature exists on the psychosocial impact of other implanted medical devices, data do not exist for InterStim therapy. We aim to evaluate the relationship between optimism and treatment satisfaction in women undergoing InterStim for refractory OAB and change in OAB symptoms. Adult women undergoing InterStim therapy for refractory OAB completed a series of validated questionnaires before test stimulation assessing optimism, urinary symptom severity, depression, and body image. Questionnaires included the Life Orientation Test-Revised, OAB Questionnaire-Short Form, Major Depression Inventory, and a body image scale. Three months postoperatively, participants repeated the questionnaires to assess urinary symptoms, depression, and body image and completed the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q). Correlations assessed the relationship between the Life Orientation Test-Revised score and OAB-SAT-q subscale scores, and the OAB questionnaire subscale change scores. Subjects also completed the nonvalidated questions aimed at patients concerns regarding the implanted devices preoperatively and postoperatively. Twenty-eight women were included. Level of optimism was weakly correlated with subject satisfaction across all OAB-SAT-q subscales (r value of -0.11, -0.21, -0.42, and -0.20 for satisfaction, endorsement, adverse effects, and convenience, respectively). Optimism had a weak correlation with change in OAB symptoms in symptom severity and health-related quality of life subscales. Comparison of preoperative and postoperative questionnaires demonstrated statistically significant improvements in depression, body image, symptom severity, and health-related quality of life. Patients concerns regarding implanted devices changed only marginally. The level of optimism did not correlate with satisfaction with InterStim treatment, change in OAB symptoms, or OAB-related quality of life. Health-related quality of life, OAB symptoms, depression, and body image improved after InterStim treatment.

How Does Site of Pelvic Organ Prolapse Repair Affect Overactive Bladder Symptoms?

To assess how site of pelvic organ prolapse repair affects overactive bladder (OAB) symptoms, we compared change in OAB symptoms in women undergoing isolated anterior/apical (AA) repair versus isolated posterior (P) repair. This is a retrospective cohort study of women with bothersome OAB undergoing either AA or P prolapse repair. The subjects completed the Pelvic Floor Distress Inventory short form and the Overactive Bladder Questionnaire (OAB-q) validated questionnaires preoperatively and 6 weeks postoperatively. Our primary outcome was OAB-q symptom severity (SS) change score (preoperative minus postoperative score) compared between the 2 groups. Of 175 subjects, 133 (76%) underwent AA repair and 42 (24%) underwent P repair. Baseline OAB-q SS scores and baseline characteristics were similar except that the AA group had more severe baseline prolapse (median pelvic organ prolapse quantification stage 3 for AA [interquartile range, 2-3] vs stage 2 for P [interquartile range, 1-3]; P<0.01] and a higher rate of concomitant midurethral sling (57% in AA vs 31% in P; P<0.01). Overall OAB symptoms significantly improved within 6 weeks of surgery (P<0.01). The mean ± SD OAB-q SS change score was higher in the AA repair group (26 ± 24 in AA vs 13 ± 28 in P; P=0.01), indicating greater improvement in OAB symptom severity after AA repair. In linear regression adjusting for age, body mass index, diabetes, stress urinary incontinence, pelvic organ prolapse quantification stage, anticholinergic use, and midurethral sling, this difference did not remain significant. Patients have significant improvement in OAB symptoms after POP repair. In adjusted analyses, there was no difference in improvement in OAB-q SS scores in the patients who had AA versus P repair.