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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658944
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Information provided by:
University Of Perugia

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).

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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

Resource links provided by the National Library of Medicine

Patients suffering from stress or mixed urinary incontinence

Information from the National Library of Medicine

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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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00658944

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Department of Urology
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
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Principal Investigator: Elisabetta Costantini, MD University Of Perugia

Additional Information:
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Responsible Party: Elisabetta Costantini, Department of Medical-Surgical Specialties, Section of Urology and Andrology Identifier: NCT00658944     History of Changes
Other Study ID Numbers: EC_ML_002
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
trans obturator tape
Maximum urethral closure pressure
Valsalva leak point pressure
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders