A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence

November 4, 2008 updated by: Hospital Severo Ochoa

A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence

Objective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI).

Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.

Intervention: 24 patients randomised to TVT and 25 to CS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Evidence comparing effectiveness of tension-free vaginal tape (TVT) and Burch's colposuspension (CS) in the long term follow-up is weak.

Objective: To compare TVT with CS as primary treatment for stress incontinence (SUI).

Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain.

Intervention: 24 patients randomised to TVT and 25 to CS. Measurements: Main outcome: Assessment before treatment and at 6-months, 1-year and 3-years postoperatively with the incontinence severity symptoms index (ISS) and the incontinence impact symptoms index (IIS) Secondary outcome: 3 groups to asses cure rates: cured, improved and failure.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Hospital Severo Ochoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between the ages of 35 and 70 who had completed their family with a clinical (Booney test positive) and urodynamic diagnosis of Stress Urinary Incontinence
  • Previous surgery for prolapse, incontinence or bladder disease, urodynamic diagnosis of detrusor overactivity, or voiding difficulty (defined as maximum flow less than 15 ml/second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 ml)
  • Cystocele over grade I
  • Previous hysterectomy
  • Body mass index (BMI) of 40 or more
  • Uncontrolled diabetes
  • Neurological disease
  • Recurrent urinary tract infections
  • Genital atrophy precluding vaginal surgery
  • Known bleeding diathesis or current anticoagulant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tvt group
Surgical treatment for incontinence: TVT
Procedure: Surgical treatment: TVT
Active Comparator: Burch group
Surgical treatment for incontinence: Colposuspension
Procedure: Surgical treatment: colposuspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)

Secondary Outcome Measures

Outcome Measure
Criteria were established to include patients in one of three groups: cure, improved and treatment failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Severo Ochoa

Investigators

  • Principal Investigator: Téllez M Martínez-Fornés, urologist, Urology department. Hospital severo Ochoa.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2008

Last Update Submitted That Met QC Criteria

November 4, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVTvsBURCH_2001_HSVO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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