Status:
COMPLETED
Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence
Lead Sponsor:
University Of Perugia
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Brief Summary
To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of fem...
Detailed Description
A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mi...
Eligibility Criteria
Inclusion
- Mixed urinary incontinence (stress component clinically predominant)
Exclusion
- \> grade II uro-genital prolapse in any vaginal compartment
- Previous incontinence surgery
- Urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
- Active pelvic inflammatory disease
- Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
- Pregnancy or lactation; AND
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00658944
Start Date
May 1 2002
End Date
February 1 2008
Last Update
April 16 2008
Active Locations (1)
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1
Department of Urology
Perugia, Perugia, Italy, 06100