Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence
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Purpose
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.
| Condition |
|---|
|
Urinary Incontinence |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
| Enrollment: | 65 |
| Study Start Date: | May 2002 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
A
Patients suffering from stress or mixed 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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Stress or mixed urinary incontinence (stress component clinically predominant), defined according to ICS guidelines, associated or not with urethral hypermobility
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Elisabetta Costantini, Department of Medical-Surgical Specialties, Section of Urology and Andrology |
| ClinicalTrials.gov Identifier: | NCT00658944 History of Changes |
| Other Study ID Numbers: | EC_ML_002, EC_ML_002s |
| Study First Received: | April 14, 2008 |
| Last Updated: | April 15, 2008 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by University Of Perugia:
|
Stress urinary incontinence Mixed urinary incontinence surgery trans obturator tape |
Maximum urethral closure pressure Valsalva leak point pressure outcome |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013