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

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ClinicalTrials.gov Identifier: NCT00782990
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
Hospital Severo Ochoa

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Surgical treatment: TVT Procedure: Surgical treatment: colposuspension Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2001
Actual Primary Completion Date : October 2004
Actual Study Completion Date : June 2007

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Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782990


Locations
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Spain
Hospital Severo Ochoa
Leganes, Madrid, Spain, 28911
Sponsors and Collaborators
Hospital Severo Ochoa
Investigators
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Principal Investigator: Téllez M Martínez-Fornés, urologist Urology department. Hospital severo Ochoa.
More Information
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Responsible Party: Miguel Téllez Martínez-Fornés, Hospital Severo Ochoa
ClinicalTrials.gov Identifier: NCT00782990    
Other Study ID Numbers: TVTvsBURCH_2001_HSVO
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008
Keywords provided by Hospital Severo Ochoa:
stress urinary incontinence
female incontinence
surgical treatment
Female stress urinary incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders