NCT01042275

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 7, 2020

Status Verified

April 1, 2010

Enrollment Period

1 year

First QC Date

January 4, 2010

Last Update Submit

January 6, 2020

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinenceretropubic slingtransobturator slingtension-free vaginal tapetransobturator tapeTVTTVT-OTOTREMEEXIVS

Outcome Measures

Primary Outcomes (1)

  • patient's satisfaction

    3/2009

Secondary Outcomes (1)

  • re-admission

    3/2009

Study Arms (5)

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who were treated at 2 Swiss public teaching hospitals

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hospital, Clinic for Gynecology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cornelia Betschart, MD

    Clinic for Gynecology, University Hospital of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 7, 2020

Record last verified: 2010-04

Locations

CH(1)