Clinical Trials Logo
  1. Home
  2. Urinary Incontinence, Stress
  3. NCT04171531

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
See also
  Status Clinical Trial Phase
Completed NCT02001714 - Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms N/A
Not yet recruiting NCT00523068 - Pharmacological vs Surgical Treatment for Mixed Incontinence Phase 4
Completed NCT00904969 - A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence N/A
Completed NCT00190827 - Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine) Phase 3
Completed NCT00190814 - Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge. Phase 3
Terminated NCT00247286 - Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial. Phase 4
Completed NCT01959347 - Combined Treatment for Mixed Incontinence Phase 3
Completed NCT00244296 - To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms Phase 4
Not yet recruiting NCT05570071 - A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI. N/A
Completed NCT02334878 - Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence Phase 3
Completed NCT01382602 - Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study Phase 3
Completed NCT03296462 - Hip External Rotation Physical Therapy Trial N/A
Recruiting NCT02750878 - Surgical Consent Process for Trans-obturator Tape Slings. N/A
Completed NCT02296099 - Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence Phase 4
Completed NCT02599051 - Transobturator Verus Single Incision Slings N/A
Completed NCT00138749 - An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence. Phase 2
Terminated NCT03614611 - Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence N/A
Completed NCT03722719 - The Knack on Female Stress Urinary Incontinence N/A
Active, not recruiting NCT02275728 - Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence N/A
Terminated NCT01358214 - Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape) N/A