A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence
Ethicon, Inc.
Summary
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).
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
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. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence. 3. Female subjects ≥ 21 years of age requiring treatment of SUI 4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings 5. Planned surgery for primary stress incontinence without concomitant prolapse surgery 6. Patient able and willing to participate in follow-up 7. Sub…
Interventions
- DeviceIntervention
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC.
Locations (4)
- Institute for Female Pelvic MedicineNorth Wales, Pennsylvania
- Bio-Medical University RomeRome
- Ospedale San Pietro FatebenefratelliRome
- Ospedale Regionale Beata VergineMendrisio