TVTO Versus TVTFFM for Urinary Stress Incontinence

Completed

• Conditions: Urinary Stress Incontinence Treated by TVT

• Registration Number: NCT01392664
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2013-02
• Study Completion: 2013-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

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

Inclusion Criteria

• Women with Urinary Stress Incontinence treated by TVT

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution of urinary stress incontinence	One year after surgery	We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.

Secondary Outcome Measures

Name	Time	Method
Side effect of surgery	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.

Trial Locations

Locations (2)

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

Clinics of Dr Neuman; 🇮🇱 Tel Aviv, Israel