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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Who can join
Ages 21 and older · Women
Full eligibility criteria
Inclusion Criteria: * Women ≥ 21 years * For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required. * A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months. * Normal PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon * Available for up to 3 years. * Agrees to randomization. Exclusion Criteria: * Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) * Urge-predominant mixed UI despite stable therapy * Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment. * Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months. * Malignancy or history of radiation of the pelvis * Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year * Incomplete emptying (PVR \> 150mL) * Prior anti-incontinence procedure * Neurogenic bladder * Unwilling to continue current UUI treatment until completion of primary outcome at 12 months * Prior adverse reaction to synthetic mesh or urethral bulking material * Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) * Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.
About the study
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).
What is being tested
- Solyx Single-incision Sling (device)
- Bulkamid Transurethral Bulking Agent (device)
Sponsor: NICHD Pelvic Floor Disorders Network · Participants: 358 · Started: Aug 28, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06480227
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.