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

Purpose

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).

Condition

  • Stress Urinary Incontinence

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
Female
Accepts 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. 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 are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. History of previous synthetic, biologic or fascial sub-urethral sling 4. Pregnancy or plans for future pregnancy 5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

Institute for Female Pelvic Medicine
North Wales, Pennsylvania 19454

More Details

Status
Recruiting
Sponsor
Ethicon, Inc.

Study Contact

Christine Romanowski
908-808-6219
cromanow@its.jnj.com