BASIS (Stress Urinary Incontinence) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to compare the outcomes of 2 treatments for women with stress urinary incontinence (SUI): transurethral bulking agent (TBA) and single-incision sling (SIS). Both treatments are FDA-approved and can help improve SUI symptoms, but they have not been directly compared to each other to see which treatment is better for certain patients and under what circumstances. We hope this study can help women and their doctors find out which option is most likely to have the best results.
Current evidence suggests that TBA and SIS are less effective than a traditional full-length mid-urethral sling procedure, but both options are less invasive and less likely to cause complications afterward.
Stress Urinary Incontinence or Stress-Dominant Mixed Urinary Incontinence
Who Can Participate in the Study?
Women ages 21+ who:
- Have bothersome stress urinary incontinence
- Do not have plans to become pregnant while enrolled in the study (about 3 years)
For more information, contact the study team at stephanie.yu@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either have a TBA or SIS procedure to treat your condition. You will not know which procedure you received until the study is over. However, if there is ever a medical need for this information to be known, we can reveal the procedure you received.
We will monitor your health and any symptoms you might have for 36 months (about 3 years) after your procedure. You will have visits with the study team at the following times after your procedure:
- 2 weeks (in-person)
- 4 weeks (in-person)
- 3 months (in-person)
- 6 months (by phone)
- 12 months (in-person)
- 24 months (by phone)
- 36 months (by phone)
Study Details
