The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence

March 15, 2020 updated by: Anne Cecile Pizzoferrato, Poissy-Saint Germain Hospital

Valsalva Urethral Profile (VUP) : a New Measure to Assess Stress Urinary Incontinence in Women

Clinical and paraclinical appraisal of stress urinary incontinence (SUI) is mainly based on the assessment of pelvic floor muscles (PFM) contraction and urethral mobility, the measurement of the maximum urethral closure pressure (MUCP) at rest by urethral pressure profilometry (UPP) and the measurement of the Valsalva leak point pressure (VLPP).

Currently, MUCP and VLPP cannot be used for diagnosing SUI because they appear to be moderately correlated with the severity of SUI.

The lack of a specific SUI biomarker could be the explanation for the poor predictive value of urodynamics and the ongoing debate on whether urodynamic testing before surgery has benefits. Our main objective was to study the value of a new urodynamic parameter in the diagnosis of female SUI: the Valsalva urethral profile (VUP)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

695

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women over the age of 18 years, referred for urodynamic exploration of the lower urinary tract, with or without lower urinary tract disorders (TUBA)
  • women who gave their consent to participate in the study.

Exclusion Criteria:

  • pelvic organ prolapse (POP) ≥ stage 2 according to the POP-Q classification
  • history of surgery for SUI and / or POP,
  • acute urinary tract infection,
  • proven neurological pathology,
  • urine retention,
  • a history of pneumothorax
  • a lability of MUCP ≥ 15 cmH2O

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: v-MUCP value
All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
Diagnostic test: Maximum urethral closure pressure during Valsalva (v-MUCP)
v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between v-MUCP and diagnosis of SUI
Time Frame: through study completion, an average of 6 months
Spearman correlation between the v-MCUP value and the ICIQ score. The ICIQ score (International Consultation on Incontinence Questionnaire-Urinary Incontinence) is a validated score used to quantify urinary incontinence (ranging from 0 = no incontinence to 21 = severe incontinence). v-MUCP (Valsalva Maximal Urethral Closure Pressure) is a urodynamic measure (measured in cmH2O). The Spearman correlation coefficient assesses how well the relationship between two variables can be described using a monotonic function.
through study completion, an average of 6 months
Correlation between v-MUCP and MUCP
Time Frame: through study completion, an average of 6 months
Spearman correlation coefficient. The Spearman correlation coefficient assesses how well the relationship between two variables can be described using a monotonic function. v-MUCP (Valsalva Maximal Urethral Closure Pressure) and MUCP Maximal Urethral Closure Pressure are two urodynamics measures (cmH2O)
through study completion, an average of 6 months
Correlation between v-MUCP and VLPP
Time Frame: through study completion, an average of 6 months
Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
through study completion, an average of 6 months
Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
Time Frame: through study completion, an average of 6 months
ROC curve. A Receiver Operating Characteristic (ROC) Curve is a way to compare diagnostic tests. It is a plot of the true positive rate against the false positive rate
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poissy-Saint Germain Hospital

Investigators

  • Principal Investigator: Philippe Dompeyre, MD, Intercommunal Hsopital center of Poissy Saint Germain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

September 25, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

March 15, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01411-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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