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:

• Stress urinary incontinence symptoms
• Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
• Female subjects ≥ 21 years of age requiring treatment of SUI
• Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
• Planned surgery for primary stress incontinence without concomitant prolapse surgery
• Patient able and willing to participate in follow-up
• 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:

• Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
• Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
• History of previous synthetic, biologic or fascial pubo-urethral sling
• Pregnancy or plans for future pregnancy
• History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
• Current genitourinary fistula or urethral diverticulum
• Reversible cause of incontinence (i.e. drug effect)
• Contraindication to surgery