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

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT02678377
Collaborator
Friends of Prentice (Other)
100
Enrollment
1
Location
2
Arms
65.8
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OnabotulinumtoxinA (Botox ®) Injections
  • Drug: Saline Injections
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jul 26, 2021
Actual Study Completion Date :
Jul 26, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Self-reported mixed urinary incontinence symptoms [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

    Secondary Outcome Measures

    1. Incontinence episode frequency [3 months after surgery]

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

    2. Urinary incontinence symptoms and quality of life [3 months after surgery]

      Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Medicine Integrated Pelvic Health Clinic Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Friends of Prentice

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kimberly Kenton, Professor, Departments of Obstetrics and Gynecology, Urology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02678377
    Other Study ID Numbers:
    • STU00201249
    First Posted:
    Feb 9, 2016
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Jul 28, 2021