A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:

⁃ Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

• 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

Locations
United States
Pennsylvania
Institute for Female Pelvic Medicine
RECRUITING
North Wales
Other Locations
Italy
Bio-Medical University Rome
RECRUITING
Rome
Ospedale San Pietro Fatebenefratelli
RECRUITING
Rome
Poland
Zelazna Medical Center
NOT_YET_RECRUITING
Warsaw
Switzerland
Ospedale Regionale Beata Vergine
RECRUITING
Mendrisio
Contact Information
Primary
Christine Romanowski
cromanow@its.jnj.com
908-808-6219
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2037-02-27
Participants
Target number of participants: 195
Sponsors
Leads: Ethicon, Inc.

This content was sourced from clinicaltrials.gov