Purpose of this Study
If you join the study, you will be placed into one of two treatment groups. One group will get a sling called a retropubic mid-urethral sling (RP-MUS). The other group will get a treatment called urethral bulking with a gel called polyacrylamide gel (PAHG). After the procedure, you will have check-up visits at 1 month, 6 months, 12 months, and 24 months. You can also choose to take part in interviews about your experience.
Who Can Participate?
Eligibility
CopilotHere is a summary for a 5th grade audience:
To join the study, you must be 18 years or older, have stress urinary incontinence (which means leaking urine when you cough, sneeze, or exercise), and be planning to have surgery to fix vaginal prolapse.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
Right now, doctors do not have strong evidence to show which treatment is better, the sling (RP-MUS) or the gel (PAHG), when fixing vaginal prolapse and stress urinary incontinence at the same time. This study will give important information about how these treatments affect patients. This will help doctors and patients choose the best option.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
BELIEVE Trial: Bulking versus sling for treating stress urinary
Incontinence at the time of vaginal prolapse repair
Incontinence at the time of vaginal prolapse repair
Principal Investigator
John
Jelovsek
Protocol Number
PRO00118020
NCT ID
NCT06754046
Enrollment Status
Pending Open to Enrollment