Post-Market Clinical Follow-Up onTVT EXACT® Continence System

Inclusion Criteria:

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Stress urinary incontinence symptoms

2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stresstest

3. Female subjects ≥ 21 years of age requiring treatment of SUI

4. Desired surgical correction of stress urinary incontinence using a syntheticpubo-urethral vaginal sling

5. Planned surgery for primary stress incontinence without concomitant prolapse surgery

6. Patient able and willing to participate in follow-up

7. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria:

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. Physical or psychological condition which would impair study participation or areunwilling or unable to participate in all required study visits and are unable tocomplete the questionnaires

2. Any pre-operative or intra-operative findings identified by the surgeon that maypreclude the use of study product

3. History of previous synthetic, biologic or fascial pubo-urethral sling

4. Pregnancy or plans for future pregnancy

5. History of bleeding diathesis or current anti-coagulation therapy which cannot besuspended peri-operatively according to site's standard practice.

6. Current genitourinary fistula or urethral diverticulum

7. Reversible cause of incontinence (i.e. drug effect)

8. Contraindication to surgery