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

Part of paid clinical trials in La Jolla, California.

Sponsor
NICHD Pelvic Floor Disorders Network
Study ID
NCT06480227
Status
Recruiting
Apply to this trial

Conditions

  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence
  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Solyx Single-incision Sling — DEVICE
    Minimally invasive mesh device placed to treat stress urinary incontinence.
  • Bulkamid Transurethral Bulking Agent — DEVICE
    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

Study Details

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).

Key Dates

Start date
Aug 28, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
358 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Solyx Single-incision Sling
    Solyx Single-incision Sling
  • Active Comparator: Bulkamid Transurethral Bulking Agent
    Bulkamid Transurethral Bulking Agent

Primary Outcome Measure

Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months. [ Time Frame: At 12 months post-intervention. ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California at San DiegoLa JollaCalifornia92037-0974
Kyle Herrala
[email protected]
(858) 657-6827
Emily Lukacz, MD (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente -- San DiegoSan DiegoCalifornia92110
Gisselle Zazueta-Damian
[email protected]
619-821-5717
Linda Mackinnon
[email protected]
619-821-6009
Shawn A Menefee, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Jinxuan (Rowena) Shi
[email protected]
872-724-0774
Kimberly Kenton, MD (PRINCIPAL_INVESTIGATOR)
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryDurhamNorth Carolina27707
Stephanie Yu
[email protected]
(919) 401-1016
Nazema Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Zandra Kennedy
[email protected]
(215) 615-6569
Heidi Harvie, MD (PRINCIPAL_INVESTIGATOR)
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic SurgeryProvidenceRhode Island02903
Madeline Malloy
[email protected]
(401) 430-8228
Vivian Sung, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Agnes Burris
[email protected]
(214) 645-3833
David Rahn, MD (PRINCIPAL_INVESTIGATOR)

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University of California at San Diego· La Jolla, CAKaiser Permanente -- San Diego· San Diego, CAUniversity of Chicago· Chicago, ILDuke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery· Durham, NCUniversity of Pennsylvania· Philadelphia, PABrown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery· Providence, RI

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