Stress Urinary Incontinence Clinical Trial
Official title:
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Verified date | February 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Medicine Integrated Pelvic Health Clinic | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Friends of Prentice |
United States,
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
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 |
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