Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence (NCT06480227)
A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of California at San Diego — La Jolla, California
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- University of California at San Diego — La Jolla, California
- Kaiser Permanente -- San Diego — San Diego, California
- University of Chicago — Chicago, Illinois
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina
- University of Pennsylvania — Philadelphia, Pennsylvania
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery — Providence, Rhode Island
- University of Texas Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (858) 657-6827
Email: UrogynRSCH@ucsd.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stress Urinary Incontinence
- Desara ® One Single Incision Sling 522 Study — Phoenix, Arizona
- Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence — Tucson, Arizona
- Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy — Coconut Creek, Florida
- Feasibility Study of A VoRo UrologIc ScaffolD (ARID) — Panama City, Punta Pacifica
- Post-Market Clinical Follow-Up onTVT EXACT® Continence System — Durham, North Carolina
- The Anabolic Effect of Testosterone on Pelvic Floor Muscles — Boston, Massachusetts
Explore by condition: All Stress Urinary Incontinence clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.