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
|Condition or disease||Intervention/treatment||Phase|
|Mixed Urinary Incontinence Stress Urinary Incontinence Urgency Incontinence||Drug: OnabotulinumtoxinA (Botox ®) Injections Drug: Saline Injections||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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
- 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
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
|United States, Illinois|
|Northwestern Medicine Integrated Pelvic Health Clinic|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Kimberly Kenton, M.D.||Professor, Departments of Obstetrics and Gynecology, Urology|