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

NCT ID: NCT00782990

Last Updated: 2008-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Keywords

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stress urinary incontinence female incontinence surgical treatment Female stress urinary incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tvt group

Surgical treatment for incontinence: TVT

Group Type ACTIVE_COMPARATOR

Surgical treatment: TVT

Intervention Type PROCEDURE

Burch group

Surgical treatment for incontinence: Colposuspension

Group Type ACTIVE_COMPARATOR

Surgical treatment: colposuspension

Intervention Type PROCEDURE

Interventions

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Surgical treatment: TVT

Intervention Type PROCEDURE

Surgical treatment: colposuspension

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Severo Ochoa

OTHER

Sponsor Role lead

Responsible Party

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Hospital Severo Ochoa

Principal Investigators

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Téllez M Martínez-Fornés, urologist

Role: PRINCIPAL_INVESTIGATOR

Urology department. Hospital severo Ochoa.

Locations

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Hospital Severo Ochoa

Leganés, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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TVTvsBURCH_2001_HSVO

Identifier Type: -

Identifier Source: org_study_id