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
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Procedure: Surgical treatment: TVT
Procedure: Surgical treatment: colposuspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence

Resource links provided by NLM:


Further study details as provided by Hospital Severo Ochoa:

Primary Outcome Measures:
  • Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)

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

Enrollment: 50
Study Start Date: January 2001
Study Completion Date: June 2007
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782990

Locations
Spain
Hospital Severo Ochoa
Leganes, Madrid, Spain, 28911
Sponsors and Collaborators
Hospital Severo Ochoa
Investigators
Principal Investigator: Téllez M Martínez-Fornés, urologist Urology department. Hospital severo Ochoa.
  More Information

No publications provided

Responsible Party: Miguel Téllez Martínez-Fornés, Hospital Severo Ochoa
ClinicalTrials.gov Identifier: NCT00782990     History of Changes
Other Study ID Numbers: TVTvsBURCH_2001_HSVO
Study First Received: October 30, 2008
Last Updated: November 4, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Severo Ochoa:
stress urinary incontinence
female incontinence
surgical treatment
Female stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014