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RECRUITING
NCT06480227
NA

Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Sponsor: NICHD Pelvic Floor Disorders Network

View on ClinicalTrials.gov

Summary

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).

Official title: A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2024-08-28

Completion Date

2030-01-01

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DEVICE

Solyx Single-incision Sling

Minimally invasive mesh device placed to treat stress urinary incontinence.

DEVICE

Bulkamid Transurethral Bulking Agent

Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed

Locations (7)

University of California at San Diego

La Jolla, California, United States

Kaiser Permanente -- San Diego

San Diego, California, United States

University of Chicago

Chicago, Illinois, United States

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States