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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042275
First Posted: January 5, 2010
Last Update Posted: April 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose
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).

Condition
Stress Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Patient-reported Mid- and Long-term Outcome After Insertion of Retropubic and Transobturator Tapes Using the Incontinence Outcome Questionnaire (IOQ)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • patient's satisfaction [ Time Frame: 3/2009 ]

Secondary Outcome Measures:
  • re-admission [ Time Frame: 3/2009 ]

Enrollment: 628
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who were treated at 2 Swiss public teaching hospitals
Criteria

Inclusion Criteria:

  • incontinence sling
  • time frame 1/1999 - 12/2007
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042275


Locations
Switzerland
University of Hospital, Clinic for Gynecology
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Cornelia Betschart, MD Clinic for Gynecology, University Hospital of Zurich
  More Information

Responsible Party: Betschart, Cornelia, Dr. med., Clinic for Gynecology, University Hospital of Zurich
ClinicalTrials.gov Identifier: NCT01042275     History of Changes
Other Study ID Numbers: FHKUZH10-2008
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: April 7, 2010
Last Verified: April 2010

Keywords provided by University of Zurich:
stress urinary incontinence
retropubic sling
transobturator sling
tension-free vaginal tape
transobturator tape
TVT
TVT-O
TOT
REMEEX
IVS

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders