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

NCT ID: NCT01042275

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

628 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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TOT

transobturator sling, outside-in (TOT)

No interventions assigned to this group

TVT-O

Tension-free transobturator tape, inside-out (TVT-O)

No interventions assigned to this group

IVS

retropubic Intravaginal Sling (IVS)

No interventions assigned to this group

TVT

retropubic tension-free vaginal tape (TVT)

No interventions assigned to this group

REMEEX

Re-adjustable mechanical external sling (REMEEX)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* incontinence sling
* time frame 1/1999 - 12/2007
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cornelia Betschart, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Gynecology, University Hospital of Zurich

Locations

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University of Hospital, Clinic for Gynecology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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FHKUZH10-2008

Identifier Type: -

Identifier Source: org_study_id

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