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

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).

Conditions

• Stress Urinary Incontinence
• Urinary Incontinence
• Mixed Urinary Incontinence

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

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• RTI International

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Emily Lukacz, MD · University of California, San Diego

• Marie Gantz, MD · RTI International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-28

Primary Completion

2028-12-31

Completion

2030-12-31

FDA Device

Yes

Countries

• United States

Study Locations