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

Poissy-Saint Germain Hospital695 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

695

Conditions

Stress Urinary Incontinence

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: through study completion, an average of 6 months