TVT Worldwide Registry

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Townsville Hospital Department of Urogynaecology, Douglas, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

Standing cough stress test

Time frame: 12 months

Secondary outcomes

I-QOL score

Time frame: 3, 6, 12 and 24 months

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study title

TVT-World Wide Observational Registry for Long-Term Data

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Mar 29, 2007
Registry last updated: May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed