Long-Term Follow-Up of the Gynecare TVT ABBREVO Continence System for Surgical Treatment of Stress Urinary Incontinence in Women

What this Trial Is About

Researchers are evaluating the performance of the Gynecare TVT ABBREVO4 Continence System in women undergoing mid-urethral sling surgery to treat Stress Urinary Incontinence SUI. This observational, post-market clinical study focuses on long-term follow-up to assess the systems impact on continence over approximately 5 to 10 years after surgery. Participants undergo surgical treatment for SUI using the Gynecare TVT ABBREVO4 device as part of standard care. There is no additional intervention in the study beyond the usual surgical procedure and clinical care. The study follows participants from the time of surgery through long-term follow-up lasting about 10 years. During the study, participants will be monitored with assessments including the Cough Stress Test CST to evaluate continence status, patient-reported improvement measures, urinary incontinence questionnaires, sexual function questionnaires, and pain rating scales. Follow-up involves regular evaluations through the study completion date to track outcomes and safety over the long term.

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System