Patient-reported Outcome After Sling Insertion Using the Incontinence Outcome Questionnaire (IOQ)

January 6, 2020 updated by: University of Zurich

Patient-reported Mid- and Long-term Outcome After Insertion of Retropubic and Transobturator Tapes Using the Incontinence Outcome Questionnaire (IOQ)

Midurethral tapes are by now standard procedure in the surgical treatment of women with stress urinary incontinence. While the retropubic TVT is well documented with long-term results up to 11 years and continence rates of 90 %, the published data for the transoburator tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was constructed to assess patient-reported outcome and quality of life after insertion of a midurethral tape and validated for the German language. The aim of this study was to evaluate patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape, inside-out (TVT-O).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University of Hospital, Clinic for Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who were treated at 2 Swiss public teaching hospitals

Description

Inclusion Criteria:

  • incontinence sling
  • time frame 1/1999 - 12/2007

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TOT
transobturator sling, outside-in (TOT)
TVT-O
Tension-free transobturator tape, inside-out (TVT-O)
IVS
retropubic Intravaginal Sling (IVS)
TVT
retropubic tension-free vaginal tape (TVT)
REMEEX
Re-adjustable mechanical external sling (REMEEX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient's satisfaction
Time Frame: 3/2009
3/2009

Secondary Outcome Measures

Outcome Measure
Time Frame
re-admission
Time Frame: 3/2009
3/2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Cornelia Betschart, MD, Clinic for Gynecology, University Hospital of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHKUZH10-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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