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

February 16, 2023 updated by: Kimberly Kenton, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine Integrated Pelvic Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Time Frame: 3 months after surgery
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
Time Frame: 3 months after surgery
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
Time Frame: 3 months after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Friends of Prentice

Investigators

  • Principal Investigator: Kimberly Kenton, M.D., Professor, Departments of Obstetrics and Gynecology, Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

July 26, 2021

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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