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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02678377
Other study ID # STU00201249
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2016
Est. completion date July 26, 2021

Study information

Verified date February 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
OnabotulinumtoxinA (Botox ®) Injections
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Saline Injections
Saline will be injected into the bladder so that investigators are masked to subject randomization.

Locations

Country Name City State
United States Northwestern Medicine Integrated Pelvic Health Clinic Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Friends of Prentice

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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
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