Trial Details

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

NCT04772131

RECRUITING

DESCRIPTION

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.

CONDITIONS

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 to proceed with a surgical intervention. 8. 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).