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CompletedNCT00658944Updated Apr 16, 2008

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

An observational study in Urinary Incontinence, sponsored by University Of Perugia. Completed at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-04-16.

Sponsored by University Of Perugia · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
65
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Urinary Incontinence

Keywords

  • Stress urinary incontinence
  • Mixed urinary incontinence
  • surgery
  • trans obturator tape
  • Maximum urethral closure pressure
  • Valsalva leak point pressure
  • outcome
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 65 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University Of Perugia is the lead sponsor of 51 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Time perspective
Prospective
Enrollment
65 participants (actual)

Groups and cohorts

  • A

    Patients suffering from stress or mixed urinary incontinence

06

Study locations

1 site
  • Department of Urology
    Perugia, 06100, Italy
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00658944
Lead sponsor
University Of Perugia
First posted
Apr 16, 2008
Start date
May 2002
Primary completion
Dec 2007
Completion
Feb 2008
Last update
Apr 16, 2008

Study contacts

Elisabetta Costantini, MD
principal investigator · University Of Perugia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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