Desara ® One Single Incision Sling 522 Study

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, female stress urinary incontinence, single incision sling, transobturator sling, Desara® One, Desara® Blue Read More

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 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 (mesh) or vaginal apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh) before the SUI implant procedure.

Exclusion criteria:

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 defined by a positive urinalysis with ≥ +5 leukocytes and confirmed with urine culture finding of 10² CFUs (colony forming units).
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 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.
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.