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.