Evaluating the Gynecare TVT ABBREVO® Continence System for treating urinary incontinence in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the performance of the Gynecare TVT ABBREVO® Continence System in women who are undergoing mid-urethral sling surgery for stress urinary incontinence (SUI). It involves a single-arm approach where eligible participants will be monitored post-surgery to evaluate the effectiveness of the continence system. The study will include women aged 21 and older who have been diagnosed with SUI and are planning to undergo surgical treatment without additional prolapse surgery. Participants will be required to provide informed consent and participate in follow-up assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute for Female Pelvic Medicine
  North Wales, Pennsylvania, United States Recruiting
• Bio-Medical University Rome
  Rome, Italy Recruiting
• Ospedale San Pietro Fatebenefratelli
  Rome, Italy Recruiting
• Ospedale Regionale Beata Vergine
  Mendrisio, Switzerland Recruiting

Study contacts

• Study coordinator: Christine Romanowski
• Email: cromanow@its.jnj.com
• Phone: 908-808-6219

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.