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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01042275
First received: January 4, 2010
Last updated: April 6, 2010
Last verified: April 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • re-admission [ Time Frame: 3/2009 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2010
Last Updated: April 6, 2010
Health Authority: Switzerland: Ethikkommission

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
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014