CompletedPhase 4

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

United States100 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms

Timeframe: 3 months after surgery

Trial details

NCT IDNCT02678377

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-26

Results submitted2022-07-25

View on ClinicalTrials.gov More Mixed Urinary Incontinence trials