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

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Urgency Incontinence; Stress Urinary Incontinence; Mixed Urinary Incontinence

Treatments: Drug: Saline Injections; Drug: OnabotulinumtoxinA (Botox ®) Injections

Study type: Interventional

Funder types: Other

Identifiers

NCT02678377

STU00201249

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

OnabotulinumtoxinA injections

Active Comparator group

Description:

100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.

Treatment:

Drug: OnabotulinumtoxinA (Botox ®) Injections

Saline injections

Sham Comparator group

Description:

100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.

Treatment:

Drug: Saline Injections