BridgeMD
Compares treatment options for Stress Urinary Incontinence
Official title Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT06480227
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only
You may be able to join 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...
- 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
You likely can't join 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...
- Malignancy or history of radiation of the pelvis
- Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Diego, California, United States
- Chicago, Illinois, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; San Diego, California, United States; Chicago, Illinois, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States; Providence, Rhode Island, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.