Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
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.
• Female ≥ 18 of age.
• Subject agrees that she is willing and able to return for all study related procedures and evaluations.
• Subject has provided signed informed consent.
• 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.
• Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
• 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:
‣ A hysterectomy or
⁃ Tubal ligation or
⁃ Is otherwise incapable of pregnancy or has
⁃ Negative pregnancy test prior to study entry and has decided to cease childbearing
• Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
• Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).