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

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ClinicalTrials.gov Identifier: NCT00658944
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
University Of Perugia

Study Description
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Brief 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.

Condition or disease
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).

Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
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
Study Start Date : May 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008

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Groups and Cohorts
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Group/Cohort
A
Patients suffering from stress or mixed urinary incontinence


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658944


Locations
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Italy
Department of Urology
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Elisabetta Costantini, MD University Of Perugia
More Information
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Additional Information:
Web site of University of Perugia  This link exits the ClinicalTrials.gov site

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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
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
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:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders