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

Hospital Severo Ochoa

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Procedure: Surgical treatment: TVT; Procedure: Surgical treatment: colposuspension

Study type: Interventional

Funder types: Other

Identifiers

NCT00782990

TVTvsBURCH_2001_HSVO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

tvt group

Active Comparator group

Description:

Surgical treatment for incontinence: TVT

Treatment:

Procedure: Surgical treatment: TVT

Burch group

Active Comparator group

Description:

Surgical treatment for incontinence: Colposuspension

Treatment:

Procedure: Surgical treatment: colposuspension