The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maximum urethral closure pressure during Valsalva (v-MUCP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
v-MUCP value
Arm Description
All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
Outcomes
Primary Outcome Measures
Correlation between v-MUCP and diagnosis of SUI
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.
Correlation between v-MUCP and MUCP
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)
Correlation between v-MUCP and VLPP
Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04311814
First Posted
February 21, 2020
Last Updated
March 15, 2020
Sponsor
Poissy-Saint Germain Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04311814
Brief Title
The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence
Official Title
Valsalva Urethral Profile (VUP) : a New Measure to Assess Stress Urinary Incontinence in Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poissy-Saint Germain Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We conducted a monocentric interventional study, carried out as part of routine care
Masking
None (Open Label)
Allocation
N/A
Enrollment
695 (Actual)
8. Arms, Groups, and Interventions
Arm Title
v-MUCP value
Arm Type
Other
Arm Description
All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
Intervention Type
Diagnostic Test
Intervention Name(s)
Maximum urethral closure pressure during Valsalva (v-MUCP)
Intervention Description
v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract
Primary Outcome Measure Information:
Title
Correlation between v-MUCP and diagnosis of SUI
Description
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.
Time Frame
through study completion, an average of 6 months
Title
Correlation between v-MUCP and MUCP
Description
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)
Time Frame
through study completion, an average of 6 months
Title
Correlation between v-MUCP and VLPP
Description
Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
Time Frame
through study completion, an average of 6 months
Title
Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
Description
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
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Dompeyre, MD
Organizational Affiliation
Intercommunal Hsopital center of Poissy Saint Germain
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence
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