Status:
COMPLETED
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress Incontinence
Lead Sponsor:
Hospital Severo Ochoa
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
35-70 years
Phase:
PHASE4
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 ...
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 treat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00782990
Start Date
January 1 2001
End Date
June 1 2007
Last Update
November 5 2008
Active Locations (1)
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1
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911