Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Preoperative MUCP and VLPP Failed to Predict Long Term (4-Years) Outcome in Patients Who Underwent Transobturator Mid-Urethral Slings. a Prospective Observational Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658944
• Other study ID #: EC_ML_002
• Secondary ID: EC_ML_002s
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: April 15, 2008
• Start date: May 2002
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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 female stress urinary incontinence.

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 mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or > 40 cmH20 and ≤ or > 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Mixed urinary incontinence (stress component clinically predominant)

Exclusion Criteria:

• > 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Italy	Department of Urology	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

External Links

•   Web site of University of Perugia