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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678377
• Other study ID #: STU00201249
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: July 26, 2021

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Mixed Urinary Incontinence
• Stress Urinary Incontinence
• Urgency Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Medicine Integrated Pelvic Health Clinic	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Friends of Prentice

Country where clinical trial is conducted

United States, 

References & Publications (1)

Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Ja — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms	Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome	3 months after surgery
Secondary	Incontinence Episode Frequency	Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject	3 months after surgery
Secondary	Urinary Incontinence Symptoms and Quality of Life	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.	3 months after surgery