CompletedNot Applicable

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

695 participantsStarted 2016-02-15

Plain-language 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)

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between v-MUCP and diagnosis of SUI

Timeframe: through study completion, an average of 6 months

Correlation between v-MUCP and MUCP

Timeframe: through study completion, an average of 6 months

Correlation between v-MUCP and VLPP

Timeframe: 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)

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT04311814

SponsorPoissy-Saint Germain Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-25

View on ClinicalTrials.gov More Stress Urinary Incontinence trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Correlation between v-MUCP and diagnosis of SUI

Timeframe: through study completion, an average of 6 months

Correlation between v-MUCP and MUCP

Timeframe: through study completion, an average of 6 months

Correlation between v-MUCP and VLPP

Timeframe: 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)

Timeframe: through study completion, an average of 6 months