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

NCT04311814 | Completed

• 1 other identifier: 2015-A01411-48
• Study Type: interventional
• Target: 695
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Stress Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  through study completion, an average of 6 months

• 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)

  through study completion, an average of 6 months

• 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

  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)

  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

  through study completion, an average of 6 months

Study Arms (1)

v-MUCP value

OTHER

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

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

Interventions

Maximum urethral closure pressure during Valsalva (v-MUCP) DIAGNOSTIC_TEST

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

v-MUCP value

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead

Related Publications (14)

• 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.

  PMID: 8108659 BACKGROUND

• 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.

  PMID: 8203431 BACKGROUND

• 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.

  PMID: 18423707 BACKGROUND

• 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.

  PMID: 7645634 BACKGROUND

• 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.

  PMID: 8411422 BACKGROUND

• 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.

  PMID: 7645615 BACKGROUND

• 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.

  PMID: 8694033 BACKGROUND

• 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.

  PMID: 26872575 BACKGROUND

• 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.

  PMID: 15227649 BACKGROUND

• 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.

  PMID: 15977259 BACKGROUND

• 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.

  PMID: 20236751 BACKGROUND

• 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.

  PMID: 11795644 BACKGROUND

• 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.

  PMID: 28673060 BACKGROUND

• 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.

  PMID: 11294530 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Dompeyre, MD

  Intercommunal Hsopital center of Poissy Saint Germain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 17, 2020
• Study Start: February 15, 2016
• Primary Completion: September 25, 2019
• Study Completion: December 20, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03