NCT04171531

Sling vs Botox for Mixed Incontinence

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 outcomes include: • Urogenital Distress Inventory Stress and Irritative subscales Other outcomes include: * Urogenital Distress Inventory Obstructive subscale * Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency * Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36 * Physical measures of effectiveness: Postvoid Residual Volume 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. Those results are not reported with this record.

Conditions

• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Interventions

Type	Name	Description
DRUG	Botox® injection	Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
DEVICE	Mid-urethral sling	Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. "Mini-sling" and "single-incision" sling will not be allowed due to potential risk for higher failure rate.

Timeline

• Start date: 2020-06-08
• Primary completion: 2024-02-12
• Completion: 2024-02-12
• First posted: 2019-11-21
• Last updated: 2025-06-03
• Results posted: 2025-03-20

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study