Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

Inclusion Criteria:

1. Female ≥ 18 years of age

2. Willing and able to comply with the study procedures and provide written informed
consent to participate in the study (subject or legal representative)

3. Diagnosed with predominant SUI confirmed by positive cough stress test during the
protocol required bladder fill procedure (see manual of operations)

4. Confirmed SUI is greater than urge incontinence with MESA

5. Cystometric capacity ≥ 300 cc

6. Post-void residual (PVR) of ≤ 150 cc

7. Medically approved for general, regional or monitored anesthesia

Exclusion Criteria:

1. Subjects who are pregnant, lactating, or planning future pregnancies

2. Subjects with a chief complaint of overactive bladder

3. Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2
culture-proven urinary tract infections during a 6-month period prior to surgery or ≥
3 in a 12-month period

4. Subjects with previous surgical procedures for SUI including bulking, urethral sling,
bone anchor, Burch procedure, pubo-vaginal sling, and MMK procedure. Excluding Kelly
plication, Botox, anterior repair, or Inter-Stim

5. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications

6. Subjects with previous radiation therapy to the pelvis

7. Subjects with known or suspected hypersensitivity to polypropylene mesh

8. Subjects with any of the following confounding conditions:

1. Neurogenic bladder

2. Urethral stricture and bladder neck contracture

3. Bladder stones or tumors

4. Urinary tract fistula or diverticula

5. Pathology which would compromise implant placement including subjects currently
taking anticoagulation therapy

6. Pathology that would limit blood supply or infections that would compromise
healing including chemotherapy, systemic steroids and systemic immunosuppressants

9. Subjects with diabetes and an A1c ≥ 7%

10. Non-English speaking subjects

11. Subjects who have participated in an investigational study (medical device or drug)
within 30 days of study entry that may impact analysis of this device or have
previously participated in the current study