Trial Parameters
Brief Summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Eligibility Criteria
Inclusion Criteria: 1. Female ≥ 18 of age. 2. Subject agrees that she is willing and able to return for all study related procedures and evaluations. 3. Subject has provided signed informed consent. 4. Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound. 5. Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire. 6. Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of: 1. A hysterectomy or 2. Tubal ligation or 3. Is otherwise incapable of pregnancy or has 4. Negative pregnancy test prior to study entry and has decided to cease childbearing 7. Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected