Desara ® One Single Incision Sling 522 Study

Eligibility 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).
• 1. Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
• 2. Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
• 3. Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
• 4. Subject has a history of chronic opioid, or narcotic use for:
• 1. pain or
• 2. any other specified reason
• 5. Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
• 6. Subject is on chronic (\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
• 7. Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose \> 130mg/dl at screening/baseline.
• 8. Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
• 9. Subject has active UTI which requires treatment, as determined by the Investigator.
• 10. Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
• 11. Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
• 12. The subject has had:
• 1. any prior surgical stress urinary incontinence treatment or
• 2. any prior surgery on their urethra or
• 3. any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
• 4. any previous pelvic floor mesh use or complication
• 13. Subject has any of the following confounding conditions:
• 1. bladder stones or tumors
• 2. pathology that in the opinion of the Investigator would compromise implant placement
• 3. pathology that would limit pelvic blood supply
• 4. pathology that would require chemotherapy and systemic use of immunosuppressants
• 14. Subject has abnormal bladder capacity \<300 mL.
• 15. Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
• 16. Subject has had previous radiation therapy or brachytherapy to the pelvis.
• 17. Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
• 18. Subject has known reaction, sensitivity or allergy to polypropylene.