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

NARecruitingINTERVENTIONAL
Enrollment

358

Participants

Timeline

Start Date

August 28, 2024

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2029

Conditions
Stress Urinary IncontinenceUrinary IncontinenceMixed 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

Trial Locations (7)

19104

RECRUITING

University of Pennsylvania, Philadelphia

27707

RECRUITING

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham

60637

RECRUITING

University of Chicago, Chicago

75390

NOT_YET_RECRUITING

University of Texas Southwestern Medical Center, Dallas

92110

RECRUITING

Kaiser Permanente -- San Diego, San Diego

92037-0974

RECRUITING

University of California at San Diego, La Jolla

02903

RECRUITING

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

University of Chicago

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Women and Infants Hospital of Rhode Island

OTHER

collaborator

RTI International

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

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

NIH

lead

NICHD Pelvic Floor Disorders Network

NETWORK

NCT06480227 - Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter