Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
Recruiting now · Not applicable
Conditions studied: Stress Urinary Incontinence, Urinary Incontinence, Mixed Urinary Incontinence
In brief
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 facts
- Study ID
- NCT06480227
- Run by
- NICHD Pelvic Floor Disorders Network
- People needed
- 358
- Starts
- 2024-08-28
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California at San Diego — La Jolla, California, United States (enrolling)
- Kaiser Permanente -- San Diego — San Diego, California, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery — Providence, Rhode Island, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.