The BASIS trial (BASIS)
Brief description of study
This study will compare two treatments for Stress Urinary Incontinence, transurethral bulking agent (TBA) and single-incision sling (SIS). Patients unresponsive to conservative treatments, interested in minimally invasive surgical treatment will be asked to take part in this study. The purpose of this research is to help doctors determine the best way to treat patients with stress urinary incontinence and determine that these procedures can be done in a clinic setting in the future.
Detailed description of study
Participants will be randomized to one of two study groups and come to the hospital or surgical center in order to receive either the transurethral bulking agent or single incision sling surgery. Subjects will be given a local anesthesia for the procedure but may elect to go to sleep per standard anesthesia care. For the remainder of the study, subjects will answer questionnaires about bladder health and quality of life. At 2-4 weeks, 3, 12-months post treatment participants will undergo a pelvic exam. If you are still experiencing stress urinary incontinence at your 3 month visit, regardless of whatever group you were randomized to, you may be eligible to receive an injection of the transurethral bulking agent. At 6, 24, and 36 months after surgery, you will have a phone call with the research staff to collect information about any changes in health and questionnaires on symptoms and quality of life. You will not know what your initial procedure was until the end of the study unless you or your doctors need to know for medical reasons.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 21 years or above
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Gender: Female
- Available to participate for 3 years
- Agreement to be randomized to either study group
- Do not plan to become pregnant during the study (36 month duration)
- >21 years with bothersome stress urinary incontinence (SUI)
- Failed or unable to perform conservative management for SUI including pelvic floor strengthening
- Failed or declined a pessary option for SUI
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