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

Urinary Incontinence Clinical Trial

Official title:

A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782990
• Other study ID #: TVTvsBURCH_2001_HSVO
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2008
• Last updated: November 4, 2008
• Start date: January 2001
• Est. completion date: June 2007

Study information

• Verified date: November 2008
• Source: Hospital Severo Ochoa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2007
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Surgical treatment: TVT

• Surgical treatment: colposuspension

Locations

Country	Name	City	State
Spain	Hospital Severo Ochoa	Leganes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Severo Ochoa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Secondary	Criteria were established to include patients in one of three groups: cure, improved and treatment failure