NCT01392664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

4 years

First QC Date

June 29, 2011

Last Update Submit

June 6, 2016

Conditions

Urinary Stress Incontinence Treated by TVT

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Side effect of surgery

    six-12 months

Eligibility Criteria

Age18 Years - 95 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with Urinary Stress Incontinence treated by TVT

You may qualify if:

  • Women with Urinary Stress Incontinence treated by TVT

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Obstetrics and Gynecology, Western Galilee Hospital

Nahariya, Israel

Location

Clinics of Dr Neuman

Tel Aviv, Israel

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 12, 2011

Study Start

February 1, 2009

Primary Completion

February 1, 2013

Study Completion

July 1, 2013

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

IL(2)