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

This study has been completed.
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00658944
First received: April 14, 2008
Last updated: April 15, 2008
Last verified: April 2008
  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

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

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
Study Population

Stress or mixed urinary incontinence (stress component clinically predominant), defined according to ICS guidelines, associated or not with urethral hypermobility

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00658944

Locations
Italy
Department of Urology
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
Investigators
Principal Investigator: Elisabetta Costantini, MD University Of Perugia
  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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014