Clinical trialNCT06480227RecruitingInterventional

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

SponsorNICHD Pelvic Floor Disorders NetworkEnrollment358Mixed Urinary IncontinenceStress Urinary IncontinenceUrinary Incontinence

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Emily Lukacz, MD
University of California, San Diego
Principal Investigator
clinicaltrials.gov ↗
Marie Gantz, MD
RTI International
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California at San Diego
La Jolla, California, United States
Emily Lukacz, MD
Recruiting
Kaiser Permanente -- San Diego
San Diego, California, United States
Shawn A Menefee, MD
Recruiting
University of Chicago
Chicago, Illinois, United States
Kimberly Kenton, MD
Recruiting
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
Nazema Siddiqui, MD
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Heidi Harvie, MD
Recruiting
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, United States
Vivian Sung, MD
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
David Rahn, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Aug 2024
Primary completion: 31 Dec 2028
Completion: 31 Dec 2030
Last update posted: 8 Jun 2026
Registered enrollment: 358
Registry id: NCT06480227

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.