Official Title
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Phase
Phase 4Lead Sponsor
Northwestern UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Mixed Urinary Incontinence Stress Urinary Incontinence Urgency IncontinenceIntervention/Treatment
rimabotulinumtoxinB sodium chloride ...Study Participants
100This 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.
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Saline will be injected into the bladder so that investigators are masked to subject randomization.
100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
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
| Event Type | Organ System | Event Term | Placebo Group/Saline Injections | Onabotulinum Toxin A Group |
|---|
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.
