A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
NICHD Pelvic Floor Disorders Network
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).
Description
The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS. All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence coll…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Women ≥ 21 years * Bothersome SUI (PFDI-20 Q:#17 of somewhat, moderately or quite a bit) or stress predominant MUI (PFDI-20 Q:#16 \< Q:#17)50 for \> 3 months with well-controlled UUI on stable medication treatment through baseline and follow-up. * A positive cough stress test or urodynamic SUI within the past 18 months. * Normal voiding function as demonstrated by PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon (i.e., failed or unable to perform conservative management for SUI including pelvic floor strengthening and failed or decli…
Interventions
- DeviceSolyx Single-incision Sling
Minimally invasive mesh device placed to treat stress urinary incontinence.
- DeviceBulkamid 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 DiegoLa Jolla, California
- Kaiser Permanente -- San DiegoSan Diego, California
- University of ChicagoChicago, Illinois
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryDurham, North Carolina
- University of PennsylvaniaPhiladelphia, Pennsylvania
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic SurgeryProvidence, Rhode Island