Actively Recruiting
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Led by NICHD Pelvic Floor Disorders Network · Updated on 2026-04-30
358
Participants Needed
7
Research Sites
330 weeks
Total Duration
On this page
Sponsors
N
NICHD Pelvic Floor Disorders Network
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
CONDITIONS
Official Title
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 21 years or older
- Experiencing bothersome stress urinary incontinence or stress-predominant mixed urinary incontinence for over 3 months with well-controlled urgency urinary incontinence on stable medication
- Positive cough stress test or urodynamic stress urinary incontinence within the past 18 months
- Normal bladder emptying with post-void residual less than 150 mL
- Suitable candidate for either study procedure as determined by the surgeon
- Available to participate for up to 3 years
- Agree to be randomly assigned to treatment
You will not qualify if you...
- Vaginal prolapse beyond the hymen requiring additional surgery
- Urge-predominant mixed urinary incontinence despite stable therapy
- Planned hysterectomy or urethral/anterior/apical surgeries during study period
- History of pelvic cancer or radiation
- Pregnant, breastfeeding, or planning pregnancy within 1 year
- Incomplete bladder emptying with post-void residual over 150 mL
- Previous anti-incontinence surgery
- Neurogenic bladder conditions
- Prior adverse reaction to synthetic mesh or polyacrylamide
- Chronic bladder or pelvic pain conditions
- Active third-line treatment for overactive bladder or urgency urinary incontinence within 12 months or planned within 1 year
- Current active treatment for stress urinary incontinence with pessary without a 3-week washout period before baseline
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California at San Diego
La Jolla, California, United States, 92037-0974
Actively Recruiting
2
Kaiser Permanente -- San Diego
San Diego, California, United States, 92110
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 27707
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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