search
Back to results

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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maximum urethral closure pressure during Valsalva (v-MUCP)
Sponsored by
Poissy-Saint Germain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    v-MUCP value

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Correlation between v-MUCP and diagnosis of SUI
    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
    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)
    Correlation between v-MUCP and VLPP
    Spearman 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)
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2020
    Last Updated
    March 15, 2020
    Sponsor
    Poissy-Saint Germain Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04311814
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 15, 2016 (Actual)
    Primary Completion Date
    September 25, 2019 (Actual)
    Study Completion Date
    December 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Poissy-Saint Germain Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Urinary Incontinence
    Keywords
    Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    We conducted a monocentric interventional study, carried out as part of routine care
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    695 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    v-MUCP value
    Arm Type
    Other
    Arm Description
    All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Maximum urethral closure pressure during Valsalva (v-MUCP)
    Intervention Description
    v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract
    Primary Outcome Measure Information:
    Title
    Correlation between v-MUCP and diagnosis of SUI
    Description
    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.
    Time Frame
    through study completion, an average of 6 months
    Title
    Correlation between v-MUCP and MUCP
    Description
    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)
    Time Frame
    through study completion, an average of 6 months
    Title
    Correlation between v-MUCP and VLPP
    Description
    Spearman correlation, v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) and VLPP (Valsalva Leak Point Pressure, cmH2O) are urodyamic measures
    Time Frame
    through study completion, an average of 6 months
    Title
    Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
    Description
    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
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philippe Dompeyre, MD
    Organizational Affiliation
    Intercommunal Hsopital center of Poissy Saint Germain
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    8108659
    Citation
    Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl. 1993;153:1-93. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8203431
    Citation
    DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
    Results Reference
    background
    PubMed Identifier
    18423707
    Citation
    DeLancey JO, Trowbridge ER, Miller JM, Morgan DM, Guire K, Fenner DE, Weadock WJ, Ashton-Miller JA. Stress urinary incontinence: relative importance of urethral support and urethral closure pressure. J Urol. 2008 Jun;179(6):2286-90; discussion 2290. doi: 10.1016/j.juro.2008.01.098. Epub 2008 Apr 18.
    Results Reference
    background
    PubMed Identifier
    7645634
    Citation
    Bump RC, Elser DM, Theofrastous JP, McClish DK. Valsalva leak point pressures in women with genuine stress incontinence: reproducibility, effect of catheter caliber, and correlations with other measures of urethral resistance. Continence Program for Women Research Group. Am J Obstet Gynecol. 1995 Aug;173(2):551-7. doi: 10.1016/0002-9378(95)90281-3.
    Results Reference
    background
    PubMed Identifier
    8411422
    Citation
    McGuire EJ, Fitzpatrick CC, Wan J, Bloom D, Sanvordenker J, Ritchey M, Gormley EA. Clinical assessment of urethral sphincter function. J Urol. 1993 Nov;150(5 Pt 1):1452-4. doi: 10.1016/s0022-5347(17)35806-8.
    Results Reference
    background
    PubMed Identifier
    7645615
    Citation
    Theofrastous JP, Bump RC, Elser DM, Wyman JF, McClish DK. Correlation of urodynamic measures of urethral resistance with clinical measures of incontinence severity in women with pure genuine stress incontinence. The Continence Program for Women Research Group. Am J Obstet Gynecol. 1995 Aug;173(2):407-12; discussion 412-4. doi: 10.1016/0002-9378(95)90260-0.
    Results Reference
    background
    PubMed Identifier
    8694033
    Citation
    Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
    Results Reference
    background
    PubMed Identifier
    26872575
    Citation
    Kirschner-Hermanns R, Anding R, Rosier P, Birder L, Andersson KE, Djurhuus JC. Fundamentals and clinical perspective of urethral sphincter instability as a contributing factor in patients with lower urinary tract dysfunction--ICI-RS 2014. Neurourol Urodyn. 2016 Feb;35(2):318-23. doi: 10.1002/nau.22815.
    Results Reference
    background
    PubMed Identifier
    15227649
    Citation
    Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
    Results Reference
    background
    PubMed Identifier
    15977259
    Citation
    Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.
    Results Reference
    background
    PubMed Identifier
    20236751
    Citation
    Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16.
    Results Reference
    background
    PubMed Identifier
    11795644
    Citation
    Nager CW, Schulz JA, Stanton SL, Monga A. Correlation of urethral closure pressure, leak-point pressure and incontinence severity measures. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):395-400. doi: 10.1007/s001920170020.
    Results Reference
    background
    PubMed Identifier
    28673060
    Citation
    Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21.
    Results Reference
    background
    PubMed Identifier
    11294530
    Citation
    Dietz HP, Clarke B. The urethral pressure profile and ultrasound imaging of the lower urinary tract. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(1):38-41. doi: 10.1007/s001920170092.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs