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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014