The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence

• Status: Completed
• Trial end date: 2021-07-26
• Target enrollment: 0
• Participant gender: Female

Summary

This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Friends of Prentice; Friends of Prentice Foundation
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Undergoing mid-urethral sling surgery

• Have symptoms of both stress and urgency urinary incontinence

• Able to consent, fill out study documents, and complete all study procedures and follow-up visits

• At least 18 years of age

• English speaking

• Be able and willing to learn clean intermittent self catheterization technique

Exclusion Criteria:

• History of recurrent UTI (defined as three culture proven UTIs within last 12 months)

• Systemic neuromuscular disease known to affect the lower urinary tract

• Undergoing concomitant prolapse surgery

• Previous incontinence surgery

• Treatment with anticholinergic medication in the last 2 months

• Previous bladder injection with onabotulinumtoxinA

• Prisoner Status

• Pregnancy