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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2021-07-26

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.

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Detailed Description

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Conditions

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Mixed Urinary Incontinence Stress Urinary Incontinence Urgency Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OnabotulinumtoxinA injections

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

Group Type ACTIVE_COMPARATOR

OnabotulinumtoxinA (Botox ®) Injections

Intervention Type DRUG

OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.

Saline injections

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

Group Type SHAM_COMPARATOR

Saline Injections

Intervention Type DRUG

Saline will be injected into the bladder so that investigators are masked to subject randomization.

Interventions

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OnabotulinumtoxinA (Botox ®) Injections

OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.

Intervention Type DRUG

Saline Injections

Saline will be injected into the bladder so that investigators are masked to subject randomization.

Intervention Type DRUG

Other Intervention Names

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Botox ®

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No