BridgeMD
Compares treatment options for Stress Urinary Incontinence
Official title BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
ClinicalTrials.gov ID: NCT06754046
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure?
- Time commitment: about 24 months
- 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 18 and older, women only
You may be able to join if
- Women ≥ 18 years of age.
- Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).
- Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing,
- Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide...
You likely can't join if
- Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue
- Patient anticipating difficulty with completing 24-month follow-up
- Anticipation of pregnancy within subsequent 24-months or \<18 months post-partum
- Hemoglobin A1c \>10.0% within the past 3-months
- Current smoker \> 1 pack per week
- History of neurogenic bladder
See the full eligibility criteria
- Women ≥ 18 years of age.
- Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).
- Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing,
- Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)
- Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue
- Patient anticipating difficulty with completing 24-month follow-up
- Anticipation of pregnancy within subsequent 24-months or \<18 months post-partum
- Hemoglobin A1c \>10.0% within the past 3-months
- Current smoker \> 1 pack per week
- History of neurogenic bladder
- Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter
- Post-void residual \>150 mL felt to not be due to obstruction for prolapse
- Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking
- Previous history of any pelvic radiation
- Patient receiving a planned concurrent procedure at the time of prolapse repair.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. 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.