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OpenTrials
Completed

NCT Number: NCT01392664

TVTO Versus TVTFFM for Urinary Stress Incontinence

Women who had urinary stress incontinence and underwent one of two procedures: the classic TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.

Completed

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Key information

Conditions

Urinary Stress Incontinence Treated by TVT

Age range

18 year–95 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Western Galilee Hospital, Nahariya, Israel

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About this study

We will enroll women that underwent one of the two surgeries: TVTO or the modification where the needle passes somewhat to the side to prevent the post operative pain, for urinary stress incontinence. Data will be collected from the charts. Telephone interviews will be carried out. Physical examination will also be incorporated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with Urinary Stress Incontinence treated by TVT

Exclusion criteria

  • Women without with Urinary Stress Incontinence or not treated by TVT

Treatment and study plan

Primary outcomes

  1. Resolution of urinary stress incontinence

    Time frame: One year after surgery

    We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.

Secondary outcomes

  1. Side effect of surgery

    Time frame: six-12 months

    We will question the women if they have symptoms such as pain in the hip joints, vaginal discharge and bleeding. Physical examination will be retrieved from the charts.

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2011
Registry last updated
Jun 7, 2016

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.