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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678377
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Friends of Prentice
Information provided by (Responsible Party):
Kimberly Kenton, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Official Title  ICMJE The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence
  • Urgency Incontinence
Intervention  ICMJE
  • Drug: OnabotulinumtoxinA (Botox ®) Injections
    OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
    Other Name: Botox ®
  • Drug: Saline Injections
    Saline will be injected into the bladder so that investigators are masked to subject randomization.
Study Arms  ICMJE
  • Active Comparator: OnabotulinumtoxinA injections
    100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
    Intervention: Drug: OnabotulinumtoxinA (Botox ®) Injections
  • Sham Comparator: Saline injections
    100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
    Intervention: Drug: Saline Injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678377
Other Study ID Numbers  ICMJE STU00201249
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberly Kenton, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Friends of Prentice
Investigators  ICMJE
Principal Investigator: Kimberly Kenton, M.D. Professor, Departments of Obstetrics and Gynecology, Urology
PRS Account Northwestern University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP