NCT00135616

Brief Summary

The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2005

Typical duration for phase_4

Geographic Reach
1 country

14 active sites

Status
unknown

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, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 30, 2007

Status Verified

April 1, 2007

First QC Date

August 25, 2005

Last Update Submit

April 27, 2007

Conditions

Urinary Incontinence, Stress

Keywords

urinary incontinencestress incontinenceurethragynaecologic surgical proceduressuburethral sling

Outcome Measures

Primary Outcomes (2)

  • pre operative complication: rate of bladder perforation

  • post operative complication: rate of post-operative pain

Secondary Outcomes (2)

  • efficacy: disparation of urinary incontinence

  • safety: sexual behaviour

Interventions

surgical placement of a suburethral sling tvt or tvt-oDEVICE

Eligibility Criteria

Age18 Years - 95 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman over 18 years old
  • Clinical diagnosis of stress urinary incontinence requiring surgical management
  • Must be able to read and sign the consent

You may not qualify if:

  • Pregnancy
  • Anti-coagulant treatment
  • Isolated overactive bladder syndrome
  • Genital prolapse requiring surgical treatment
  • Concomitant hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CHU Amiens

Amiens, 80000, France

Location

Centre Hospitalier Universitaire

Angers, 49000, France

Location

CHU Pellegrin

Bordeaux, 33000, France

Location

Hopital Saint Andre

Bordeaux, 33000, France

Location

CH Chambery

Chambéry, 73000, France

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

Hôtel Dieu

Clermont-Ferrand, 63058, France

Location

CH Dunkerque

Dunkirk, 59000, France

Location

Centre Hospitalier Paul Ardier

Issoire, 63500, France

Location

Chu Nancy

Nancy, France

Location

CH Caremeau

Nîmes, 30000, France

Location

Hopital Diaconesses Croix Saint Simon

Paris, 75012, France

Location

CH Rennes

Rennes, 35000, France

Location

CH Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xavier Deffieux, MD

    Hopital Antoine Beclere, Clamart, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2008

Last Updated

April 30, 2007

Record last verified: 2007-04

Locations

FR(14)