TVT Worldwide Registry

Ethicon

Status: Completed

Conditions: Stress Urinary Incontinence

Study type: Observational

Funder types: Industry

Identifiers

NCT00453739

300-06-006

Details and patient eligibility

About

The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.

Full description

Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System

Enrollment: 1,407 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).