Clinical trial NCT04311814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Urodynamics
Maximal urethral cloture pressure
Bladder neck mobility
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 695
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We conducted a monocentric interventional study, carried out as part of routine care
Primary purpose: DIAGNOSTIC

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)


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

Primary outcomes:
measure: Correlation between v-MUCP and diagnosis of SUI
timeFrame: through study completion, an average of 6 months
measure: Correlation between v-MUCP and MUCP
timeFrame: through study completion, an average of 6 months
measure: Correlation between v-MUCP and VLPP
timeFrame: through study completion, an average of 6 months
measure: Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Intercommunal Hsopital center of Poissy Saint Germain
name: Philippe Dompeyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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