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

STU00201249

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.

2016-02-01

2021-07-26

2021-07-26

Completed

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-03-14