Stress Urinary Incontinence Clinical Trial
Official title:
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Verified date | February 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 26, 2021 |
Est. primary completion date | July 26, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Medicine Integrated Pelvic Health Clinic | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Friends of Prentice |
United States,
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 Ja — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months after surgery | |
Secondary | Incontinence Episode Frequency | Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject | 3 months after surgery | |
Secondary | 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. | 3 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04829357 -
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
|
||
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT04512053 -
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
|
Phase 2 | |
Active, not recruiting |
NCT06224335 -
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
|
||
Recruiting |
NCT05304312 -
The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women
|
N/A | |
Not yet recruiting |
NCT05527665 -
Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
|
||
Not yet recruiting |
NCT04558762 -
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
|
||
Withdrawn |
NCT02524366 -
A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
|
N/A | |
Completed |
NCT01924728 -
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
|
N/A | |
Completed |
NCT01676662 -
Solace European Confirmatory Trial
|
N/A | |
Unknown status |
NCT01455779 -
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
|
N/A | |
Terminated |
NCT01029106 -
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
|
N/A | |
Withdrawn |
NCT00573703 -
Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
|
Phase 4 | |
Completed |
NCT01123096 -
Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
|
N/A | |
Completed |
NCT01770691 -
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
|
N/A | |
Completed |
NCT00234754 -
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
|
N/A | |
Completed |
NCT00441454 -
Retropubic vs. Transobturator Tension-free Vaginal Tape
|
N/A | |
Completed |
NCT03985345 -
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
|
N/A | |
Active, not recruiting |
NCT03671694 -
Laser Vaginal Treatment for SUI
|
N/A | |
Completed |
NCT04097288 -
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects
|
Phase 1 |