Comparing two treatments for stress urinary incontinence in women
A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
This study is testing which treatment, a special gel injection or a small surgical sling, works better for women dealing with stress urinary incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | NICHD Pelvic Floor Disorders Network Research network |
| Drugs / interventions | radiation |
| Locations | 7 sites (La Jolla, California and 6 other locations) |
| Trial ID | NCT06480227 on ClinicalTrials.gov |
What this trial studies
This multicentered, double-blind, randomized controlled trial aims to compare the effectiveness of a transurethral bulking agent (TBA) and a single-incision sling (SIS) in treating women with stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI). A total of 358 women will be randomly assigned to receive either treatment, with their outcomes assessed at multiple follow-up points over three years. The primary outcome will be measured by patient-reported improvement in symptoms at 12 months, while secondary outcomes will include retreatment rates, objective measures of improvement, and quality of life assessments. Both interventions are FDA-approved and will be administered according to their approved uses.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older who have bothersome stress urinary incontinence or stress predominant mixed urinary incontinence that has not improved with conservative management.
Not a fit: Patients with advanced vaginal prolapse or those with urge-predominant mixed urinary incontinence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with more effective treatment options for stress urinary incontinence.
How similar studies have performed: Previous studies have shown success with similar surgical interventions for urinary incontinence, indicating that this approach is well-tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 declines pessary option for SUI) * Available for up to 3 years. * Agrees to randomization. Exclusion Criteria: * Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) - Advanced prolapse may require additional surgery or potentially increase the risk of postoperative urinary obstruction and confound the results of the study. * Urge-predominant mixed UI by UDI-6 despite stable therapy - Urge predominant UI would not be expected to improve after TBA or SIS and may bias results of interventions designed specifically for stress urinary incontinence. * Planned hysterectomy, urethral or anterior/apical surgeries - additional surgery beyond TBA or SIS has potential to confound the results. Additionally, these procedures generally require general anesthesia and indwelling catheterization immediately post operatively. The impact of urethral instrumentation after TBA is unknown and could impact the efficacy of the urethral coaptation. * Malignancy or history of radiation of the pelvis - The risk of foreign material rejection and mesh complications may be higher in women with pelvic radiation and other treatment for pelvic malignancy may impact primary outcomes. * Pregnant, breast feeding or plans for pregnancy within 1 year - subsequent vaginal delivery and hormonal changes of breast feeding prior to primary outcome could impact the efficacy of either treatment. * Incomplete emptying (PVR \> 150mL) - SUI surgery may increase the risk of urinary retention. * Prior anti-incontinence procedure - the aim of the study is to identify the role of TBA and SIS in primary, uncomplicated SUI or stress predominant MUI management. * Neurogenic bladder - the aim of the study is to identify the role of TBA and SIS in primary, uncomplicated SUI or stress predominant MUI management. * Prior adverse reaction to synthetic mesh or polyacrylamide - to minimize risk of post procedure complications. * Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) - given the known risks of postoperative pain with SIS and higher risks of pain in those with baseline chronic pain, we aim to minimize post operative complications. * Active 3rd line treatment for OAB/UUI with botulinum toxin, sacral neuromodulation stimulation (SNS) or percutaneous tibial nerve stimulation (PTNS) within 12 months or plan for 3rd line or new OAB/UUI treatment within 1 year of SUI surgery. For those on stable medication OAB/UUI treatment, participants should be on stable treatment for 3 months with adequate symptom control prior to baseline measures and plan to remain on stable therapy without 3rd line treatment plans within 1 year of SUI surgery. Those who have received 3rd line treatment (Botox. PTNS or SNS) should have a washout of 1yr from and no plans for restarting within the primary outcome timeframe of 1 year post procedure. Those using SNS for bowel leakage only and no UUI symptoms do not require minimum 3 months. Participants with MUI on OAB/UUI medication therapy will still need to have SUI worse than UUI at baseline. Randomization will be stratified based on presence of UUI treatment component. * 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 this trial is running
La Jolla, California and 6 other locations
- University of California at San Diego — La Jolla, California, United States (Recruiting)
- Kaiser Permanente -- San Diego — San Diego, California, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery — Providence, Rhode Island, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Emily Lukacz, MD — University of California, San Diego
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.