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

Urinary Stress Incontinence Clinical Trial

Official title:

Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392651
• Other study ID #: 920090039
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: July 2, 2014
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2011
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Locations

Country	Name	City	State
Israel	Department of Obstetrics and Gynecology, Western Galilee Hospital	Nahariya
Israel	Clinics of Dr Neuman	Rishon Lezion

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of stress incontinence	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.	12 months	No
Secondary	Evaluation of side effects: tape erosion, pain, bleeding	We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.	12 months	Yes