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

This study has been completed.
Sponsor:
Information provided by:
Hospital Severo Ochoa
ClinicalTrials.gov Identifier:
NCT00782990
First received: October 30, 2008
Last updated: November 4, 2008
Last verified: November 2008

October 30, 2008
November 4, 2008
January 2001
October 2004   (final data collection date for primary outcome measure)
Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Same as current
Complete list of historical versions of study NCT00782990 on ClinicalTrials.gov Archive Site
Criteria were established to include patients in one of three groups: cure, improved and treatment failure
Same as current
Not Provided
Not Provided
 
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence
  • Procedure: Surgical treatment: TVT
  • Procedure: Surgical treatment: colposuspension
  • Active Comparator: tvt group
    Surgical treatment for incontinence: TVT
    Intervention: Procedure: Surgical treatment: TVT
  • Active Comparator: Burch group
    Surgical treatment for incontinence: Colposuspension
    Intervention: Procedure: Surgical treatment: colposuspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2007
October 2004   (final data collection date for primary outcome measure)

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
Female
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00782990
TVTvsBURCH_2001_HSVO
Not Provided
Miguel Téllez Martínez-Fornés, Hospital Severo Ochoa
Hospital Severo Ochoa
Not Provided
Principal Investigator: Téllez M Martínez-Fornés, urologist Urology department. Hospital severo Ochoa.
Hospital Severo Ochoa
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP