Desara ® One Single Incision Sling 522 Study

Inclusion Criteria:

1. Female ≥ 18 of age.

2. Subject agrees that she is willing and able to return for all study relatedprocedures and evaluations.

3. Subject has provided signed informed consent.

4. Subject has stress urinary incontinence (SUI) confirmed by either supine or standingcough stress test (CST) with bladder pre-fill to subjective fullness with 200-300mL, or with bladder fullness confirmed via ultrasound.

5. Subject has confirmed stress incontinence greater than urge incontinence per MESAquestionnaire.

6. Subject no longer has childbearing capacity or has a negative pregnancy test and hasdecided to cease childbearing. Childbearing capacity to be confirmed by documentedhistory of:

7. A hysterectomy or

8. Tubal ligation or

9. Is otherwise incapable of pregnancy or has

10. Negative pregnancy test prior to study entry and has decided to ceasechildbearing

11. Subject has been offered and either failed or refused alternative non-invasive SUItreatment options and has elected to proceed with a surgical intervention.

12. Subject is eligible to undergo laparoscopic/robotic (with or without mesh) orvaginal (with or without mesh) apical, anterior or posterior prolapse concomitantsurgical repair procedures (non-mesh).

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 ofneurogenic bladder).

3. Subject has known pre-existing pain syndrome and/or has been evaluated by aninterventional pain management physician.

4. Subject has a history of chronic opioid, or narcotic use for:

5. pain or

6. any other specified reason

7. Subject is on anti-coagulation therapy that cannot be suspended or adjusted for aminimum of 24-48 hours prior to planned sling implantation surgery.

8. Subject is on chronic (> 3 months) systemic steroid treatment (except forinhalational use as indicated for pulmonary conditions).

9. Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose > 130mg/dl at screening/baseline.

10. Subject has an active lesion or skin infection of the perineum, urethra, or vaginaas noted per visual pelvic exam.

11. Subject has active UTI which requires treatment, as determined by the Investigator.

12. Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.

13. Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).

14. The subject has had:

15. any prior surgical stress urinary incontinence treatment or

16. any prior surgery on their urethra or

17. any prior surgery to distal anterior vaginal wall, including fistula repair orprior cystocele repair

18. any previous pelvic floor mesh use or complication

19. Subject has any of the following confounding conditions:

20. bladder stones or tumors

21. pathology that in the opinion of the Investigator would compromise implantplacement

22. pathology that would limit pelvic blood supply

23. pathology that would require chemotherapy and systemic use ofimmunosuppressants

24. Subject has abnormal bladder capacity <300 mL.

25. 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 willbe performed concomitantly with the sling implantation)

26. Subject has had previous radiation therapy or brachytherapy to the pelvis.

27. Subject is enrolled in a concurrent clinical trial of any treatment (drug or device)that could affect continence function, interfere with clinical outcomes, or impactanalysis of this device.

28. Subject has known reaction, sensitivity or allergy to polypropylene.