RecruitingNot Applicable

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

United States, Italy, Switzerland195 participantsStarted 2021-09-09

Plain-language 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).

Who can participate

Age range21 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
✕. History of previous synthetic, biologic or fascial sub-urethral sling
✕. Pregnancy or plans for future pregnancy
✕. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
✕. Current genitourinary fistula or urethral diverticulum
✕. Reversible cause of incontinence (i.e. drug effect)
✕. Contraindication to surgery

What they're measuring

Cough Stress Test (CST) Assessment Change

Timeframe: Post-surgery through study completion, approximately 5-10 yrs

Trial details

NCT IDNCT04829357

SponsorEthicon, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-12-31

Contact for this trial

Christine Romanowski

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

View on ClinicalTrials.gov More Stress Urinary Incontinence trials