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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-05-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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

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Urinary Incontinence

Keywords

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Stress urinary incontinence Mixed urinary incontinence surgery trans obturator tape Maximum urethral closure pressure Valsalva leak point pressure outcome

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients suffering from stress or mixed urinary incontinence

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Department of Medical-Surgical Specialties, Section of Urology and Andrology

Principal Investigators

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Elisabetta Costantini, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Perugia

Locations

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Department of Urology

Perugia, Perugia, Italy

Site Status

Countries

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Italy

Other Identifiers

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EC_ML_002s

Identifier Type: -

Identifier Source: secondary_id

EC_ML_002