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

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. Identifier: NCT01042275
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : April 7, 2010
Information provided by:
University of Zurich

Brief Summary:
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 or disease
Stress Urinary Incontinence

Study Type : Observational
Actual Enrollment : 628 participants
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)
Study Start Date : March 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

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

Inclusion Criteria:

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

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 identifier (NCT number): NCT01042275

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

Responsible Party: Betschart, Cornelia, Dr. med., Clinic for Gynecology, University Hospital of Zurich Identifier: NCT01042275     History of Changes
Other Study ID Numbers: FHKUZH10-2008
First Posted: January 5, 2010    Key Record Dates
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

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