The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Diagnostic Test: Maximum urethral closure pressure during Valsalva (v-MUCP)
- Registration Number
- NCT04311814
- Lead Sponsor
- Poissy-Saint Germain Hospital
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 695
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description v-MUCP value Maximum urethral closure pressure during Valsalva (v-MUCP) All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
- Primary Outcome Measures
Name Time Method Correlation between v-MUCP and diagnosis of SUI through study completion, an average of 6 months 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 through study completion, an average of 6 months 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)
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 months 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
Correlation between v-MUCP and VLPP through study completion, an average of 6 months Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
- Secondary Outcome Measures
Name Time Method