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

Poissy-Saint Germain Hospital

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Diagnostic Test: Maximum urethral closure pressure during Valsalva (v-MUCP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04311814

2015-A01411-48

Details and patient eligibility

About

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)

Enrollment: 695 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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695 participants in 1 patient group

v-MUCP value

Other group

Description:

All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver

Treatment:

Diagnostic Test: Maximum urethral closure pressure during Valsalva (v-MUCP)