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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

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
Mixed Urinary Incontinence Stress Urinary Incontinence Urgency Incontinence Drug: OnabotulinumtoxinA (Botox ®) Injections Drug: Saline Injections Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678377


Locations
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United States, Illinois
Northwestern Medicine Integrated Pelvic Health Clinic
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Friends of Prentice
Investigators
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Principal Investigator: Kimberly Kenton, M.D. Professor, Departments of Obstetrics and Gynecology, Urology
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Responsible Party: Kimberly Kenton, Professor, Departments of Obstetrics and Gynecology, Urology, Northwestern University
ClinicalTrials.gov Identifier: NCT02678377    
Other Study ID Numbers: STU00201249
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents