Clinical trial NCT00782990: A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
Official title: A Three Year Follow-up Prospective Open Randomized Trial of Tension-Free Vaginal Tape and Colposuspension for Primary Urodynamic Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: stress urinary incontinence
female incontinence
surgical treatment
Female stress urinary incontinence
Lead sponsor: Hospital Severo Ochoa
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Subjective SUI cure evaluated with incontinence severity symptoms (ISS) and incontinence impact symptoms (IIS)
Secondary outcomes:
measure: Criteria were established to include patients in one of three groups: cure, improved and treatment failure
Other outcomes:
Locations:
city: Leganes
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
Study officials:
affiliation: Urology department. Hospital severo Ochoa.
name: Téllez M Martínez-Fornés, urologist
role: PRINCIPAL_INVESTIGATOR
References: