NCT00642109

Brief Summary

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

  • Trial with surgical intervention

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

4.7 years

First QC Date

March 17, 2008

Last Update Submit

July 25, 2015

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urodynamic stress urinary incontinence measurement

    December 2009

Study Arms (3)

TVT

OTHER

Tension-free Vaginal Tape (TVT)

Procedure: midurethral sling procedure

TOT

OTHER

Transobturator Tape outside-in (TOT Monarc)

Procedure: midurethral sling procedure

TVT-O

OTHER

Transobturator Tape inside-out (TVT-O)

Procedure: midurethral sling procedure

Interventions

midurethral sling procedurePROCEDURE

quality of life, voiding dysfunction

TOTTVTTVT-O

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
  • With or without concomitant surgery for pelvic organ prolapse
  • With or without hysterectomy

You may not qualify if:

  • No informed consent
  • No preoperative urodynamic investigation
  • Mixed urinary incontinence with predominant overactive bladder
  • Recurrent stress urinary incontinence after sling procedure
  • Begin of treatment of overactive bladder less then a month ago or non stable condition
  • Pregnancy
  • Desires future childbearing
  • Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
  • Preoperative postvoid residual urinary volume exceeding 100cc
  • Coagulopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich, clinic for gynaecology

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

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

CH(1)