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NCT01042275 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01042275
Other study ID # FHKUZH10-2008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2009
Est. completion date March 2010

Study information
Verified date April 2010
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 628
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- incontinence sling

- time frame 1/1999 - 12/2007

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University of Hospital, Clinic for Gynecology Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary patient's satisfaction 3/2009
Secondary re-admission 3/2009
See also
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Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
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Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1