Wendy W. Leng

OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Purpose: Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics. Materials and Methods: Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co‐primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed. Results: OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (−2.65 vs −0.87, p <0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p <0.001). All other overactive bladder symptoms improved vs placebo (p ≤0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p <0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed. Conclusions: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

ENTEROCYSTOPLASTY OR DETRUSOR MYECTOMY? COMPARISON OF INDICATIONS AND OUTCOMES FOR BLADDER AUGMENTATION

PURPOSE We review our experience with enterocystoplasty and detrusor myectomy to delineate clinical indications and compare operative outcomes with both types of bladder augmentation. MATERIALS AND METHODS Retrospective analysis of 61 patients who had undergone a total of 37 detrusor myectomies and 32 enterocystoplasties was performed. The patients were categorized into 6 diagnostic subsets representative of the clinical spectrum of indications for bladder augmentation. RESULTS For most clinical indications detrusor myectomy offered comparable success or significant improvement in bladder function without incurring the significant complication rate of enterocystoplasty. CONCLUSIONS Detrusor myectomy is a safe, successful method of bladder augmentation for most clinical indications. Myectomy does not hinder subsequent creation of an enterocystoplasty.

Bladder and sexual function among women with multiple sclerosis.

Objective: Genitourinary dysfunction is common in women with multiple sclerosis (MS), yet few studies have evaluated the association between bladder and sexual dysfunction in these women. The aim of this study was to determine factors, including demographic and bladder function, associated with sexual dysfunction in a sample of women with MS. Methods: One hundred and thirty-three women with MS completed questionnaires related to overall heath status, bladder function and sexual function. Response frequencies and percentages were calculated for questionnaire responses. Multivariate logistic regression analyses were performed to determine predictors of sexual dysfunction. Results: Sixty-one per cent of the sample indicated that they had a problem with bladder control. Forty-seven per cent of respondents indicated that their neurological problems interfered with their sex life. Over 70% of the sample reported that they enjoyed, felt aroused and experienced orgasm during sexual activity. Not having a sexual partner and the indication of bothersome neurological problems were the best predictors of sexual dysfunction. Interestingly, patients bothered by their urge incontinence had higher levels of orgasm compared to women not bothered by urge incontinence. Conclusions: Although over half of the women reported voiding symptoms, most still enjoyed, felt aroused and could experience orgasm. Neurological symptoms and lacking a sexual partner emerged as the best predictors of sexual dysfunction. Urge incontinence may not be a risk factor for anorgasm. Our findings elucidate the complex nature of sexual dysfunction in women with MS.

High costs of urinary incontinence among women electing surgery to treat stress incontinence.

OBJECTIVE: To estimate costs for incontinence management, health-related quality of life, and willingness to pay for incontinence improvement in women electing surgery for stress urinary incontinence. METHODS: A total of 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial, a randomized surgical trial. Baseline out-of-pocket costs for incontinence management were calculated by multiplying self-report of resources used (supplies, laundry, dry cleaning) by national resource costs (

Advantages of rectus fascial slings for urinary incontinence in children with neuropathic bladders.

2006). Health-related quality of life was estimated with the Health Utilities Index Mark 3. Participants estimated willingness to pay for 100% improvement in incontinence. Potential predictors of these outcomes were examined by using multivariable linear regression. RESULTS: Mean age was 52±10 years, and mean number of weekly incontinence episodes was 22±21. Mean and median (25%, 75% interquartile range) estimated personal costs for incontinence management among all women were

Management of female genitourinary fistulas: transvesical or transvaginal approach?

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Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations

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OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity.

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Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial.

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The relationship between overactive bladder and sexual activity in women

18) per week, and 617 (94%) women reported any cost. Costs increased significantly with incontinence frequency and mixed compared with stress incontinence. The mean and median Health Utilities Index Mark 3 scores were 0.73±0.25 and 0.84 (interquartile range 0.63, 0.92). Women were willing to pay a mean of