BELIEVE Trial - Clinical Trial
What is the 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.
The Believe study is a research project that looks at how to treat stress urinary incontinence when doctors fix vaginal prolapse. Stress urinary incontinence means leaking urine when you cough, sneeze, or exercise. Vaginal prolapse happens when the muscles that hold the bladder and other organs become weak, and the organs drop down.
Who Can Participate in the Study?
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.
What is Involved?
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.
Study Details
