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NCT01392664 Clinical Trial

TVTO Versus TVTFFM for Urinary Stress Incontinence

Urinary Stress Incontinence Treated by TVT Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01392664
Other study ID # 920090040
Secondary ID
Status Completed
Phase N/A
First received June 29, 2011
Last updated June 6, 2016
Start date February 2009
Est. completion date July 2013

Study information
Verified date June 2016
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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date July 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 95 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Department of Obstetrics and Gynecology, Western Galilee Hospital Nahariya
Israel Clinics of Dr Neuman Tel Aviv

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 Resolution of urinary stress incontinence We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved. One year after surgery No
Secondary Side effect of surgery 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. six-12 months Yes