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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mixed Urinary Incontinence, Stress Urinary Incontinence, Urgency Incontinence

Intervention / Treatment
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* Drug: OnabotulinumtoxinA (Botox ®) Injections
* Drug: Saline Injections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OnabotulinumtoxinA injections<br>100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery. | Drug: OnabotulinumtoxinA (Botox ®) Injections<br>* OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.<br>* Other names: Botox ®;|
| Sham Comparator: Saline injections<br>100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery. | Drug: Saline Injections<br>* Saline will be injected into the bladder so that investigators are masked to subject randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |