NCT02678377

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mixed Urinary Incontinence
• Stress Urinary Incontinence
• Urgency Incontinence

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA (Botox ®) Injections	OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
DRUG	Saline Injections	Saline will be injected into the bladder so that investigators are masked to subject randomization.

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2016-02-09
• Last updated: 2023-03-14
• Results posted: 2023-03-14

Locations

1 site across 1 country: United States