A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
⁃ Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
• Stress urinary incontinence symptoms
• Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
• Female subjects ≥ 21 years of age requiring treatment of SUI
• Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
• 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