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Sling vs Botox for Mixed Incontinence — MUSA  

Urinary Incontinence, Stress Clinical Trial

Official title:
Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A

Clinical Trial Summary

The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.

Clinical Trial Description

Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial. The purpose of MUSA is to: - compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI - characterize patient characteristics associated with treatment response The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory. Secondary objectives include identifying predictors of treatment failure and cost-effectiveness of treatments in this MUI population. The study will continue with an additional 6 month observational period until 12 months post treatment. A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04171531
Study type Interventional
Source NICHD Pelvic Floor Disorders Network
Contact
Status Completed
Phase Phase 3
Start date June 8, 2020
Completion date February 12, 2024
View Details
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