TVT Worldwide Registry

TVT-World Wide Observational Registry for Long-Term Data

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00453739

Enrollment

1407

Registered

2007-03-29

Start date

2007-02-28

Completion date

2010-06-30

Last updated

2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Standing cough stress test	12 months

Secondary

Measure	Time frame
I-QOL score	3, 6, 12 and 24 months

Countries

Australia, Austria, Canada, Germany, Singapore, South Africa, South Korea, United Kingdom, United States

Outcome results