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

Part of paid clinical trials in North Wales, Pennsylvania.

Sponsor
Ethicon, Inc.
Study ID
NCT04829357
Status
Recruiting
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Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Sep 9, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2033
Completion
Dec 31, 2038

Study Design

Enrollment
195 participants (estimated)

Primary Outcome Measure

Cough Stress Test (CST) Assessment Change [ Time Frame: Post-surgery through study completion, approximately 5-10 yrs ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Female Pelvic MedicineNorth WalesPennsylvania19454-

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