Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04311814
Enrollment
695
Registered
2020-03-17
Start date
2016-02-15
Completion date
2019-12-20
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility

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)

Interventions

DIAGNOSTIC_TESTMaximum urethral closure pressure during Valsalva (v-MUCP)

v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract

Sponsors

Poissy-Saint Germain Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

We conducted a monocentric interventional study, carried out as part of routine care

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between v-MUCP and diagnosis of SUIthrough study completion, an average of 6 monthsSpearman 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 MUCPthrough study completion, an average of 6 monthsSpearman 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 VLPPthrough study completion, an average of 6 monthsSpearman 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)through study completion, an average of 6 monthsROC 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026