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

Phase 4

Completed

• Conditions: Stress Urinary Incontinence; Urgency Incontinence; Mixed Urinary Incontinence
• Interventions: Drug: OnabotulinumtoxinA (Botox ®) Injections; Drug: Saline Injections

• Registration Number: NCT02678377
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Results First Submitted: 2022-07-25
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Results First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA injections	OnabotulinumtoxinA (Botox ®) Injections	100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
Saline injections	Saline Injections	100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms	3 months after surgery	Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome

Secondary Outcome Measures

Name	Time	Method
Incontinence Episode Frequency	3 months after surgery	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	3 months after surgery	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.

Trial Locations

Locations (1)

Northwestern Medicine Integrated Pelvic Health Clinic; 🇺🇸 Chicago, Illinois, United States