Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

Completed

• Conditions: Urinary Stress Incontinence

• Registration Number: NCT01392651
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-06-27
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago

Exclusion Criteria

• Women who have not undergone TVT procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of stress incontinence	12 months	We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated.

Secondary Outcome Measures

Name	Time	Method
Evaluation of side effects: tape erosion, pain, bleeding	12 months	We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.

Trial Locations

Locations (2)

Department of Obstetrics and Gynecology, Western Galilee Hospital; 🇮🇱 Nahariya, Israel

Clinics of Dr Neuman; 🇮🇱 Rishon Lezion, Israel