Clinical Trials Directory

Trials / Completed

CompletedNCT00658944

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
65 (actual)
Sponsor
University Of Perugia · Academic / Other
Sex
Female
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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 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).

Conditions

Timeline

Start date
2002-05-01
Primary completion
2007-12-01
Completion
2008-02-01
First posted
2008-04-16
Last updated
2008-04-16

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00658944. Inclusion in this directory is not an endorsement.