Phase 4
N=88
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Mixed Urinary Incontinence · Stress Urinary Incontinence · Urgency Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02678377 ↗Enrolled (actual)
88
Serious AEs
1.3%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms — 31; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OnabotulinumtoxinA (Botox ®) Injections (Drug); Saline Injections (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms |
31; 34 | — |
| SECONDARY Incontinence Episode Frequency |
0; 0 | — |
| SECONDARY Urinary Incontinence Symptoms and Quality of Life |
4.8; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02678377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.