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

Study Overview
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Brief Summary
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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)

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Diagnostic Test: Maximum urethral closure pressure during Valsalva (v-MUCP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: We conducted a monocentric interventional study, carried out as part of routine care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: v-MUCP value<br>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)<br>* v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 6 months | 
| 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) | through study completion, an average of 6 months | 
| 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility