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OpenTrials
Completed

NCT Number: NCT01426048

Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital

Treatment and study plan

Gynaecological examination and a supine stress test, questionnaires

Other

Gynaecological examination and a supine stress test, questionnaires

Primary outcomes

  1. Objective outcome of the TVT operation

    Time frame: 13.5 years

    Objective outcome was measured with negative stress test and no need for reoperation for stress urinary incontinence during the follow-up.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2008
Study completion
2011
First posted
Aug 30, 2011
Registry last updated
Jan 23, 2013

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.

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