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

Primary Purpose

Mixed Urinary Incontinence, Stress Urinary Incontinence, Urgency Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA (Botox ®) Injections
Saline Injections
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Northwestern Medicine Integrated Pelvic Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

OnabotulinumtoxinA injections

Saline injections

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incontinence Episode Frequency
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
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.

Full Information

First Posted
February 5, 2016
Last Updated
February 16, 2023
Sponsor
Northwestern University
Collaborators
Friends of Prentice
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1. Study Identification

Unique Protocol Identification Number
NCT02678377
Brief Title
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Official Title
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Friends of Prentice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Urinary Incontinence, Stress Urinary Incontinence, Urgency Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OnabotulinumtoxinA injections
Arm Type
Active Comparator
Arm Description
100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
Arm Title
Saline injections
Arm Type
Sham Comparator
Arm Description
100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA (Botox ®) Injections
Other Intervention Name(s)
Botox ®
Intervention Description
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Intervention Type
Drug
Intervention Name(s)
Saline Injections
Intervention Description
Saline will be injected into the bladder so that investigators are masked to subject randomization.
Primary Outcome Measure Information:
Title
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Description
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Incontinence Episode Frequency
Description
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Time Frame
3 months after surgery
Title
Urinary Incontinence Symptoms and Quality of Life
Description
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.
Time Frame
3 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Kenton, M.D.
Organizational Affiliation
Professor, Departments of Obstetrics and Gynecology, Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine Integrated Pelvic Health Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33278293
Citation
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 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198.
Results Reference
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The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence

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