Stress Urinary IncontinenceNCT04311814
The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence
A study testing Maximum urethral closure pressure during Valsalva (v-MUCP) in people with Stress Urinary Incontinence, run by Poissy-Saint Germain Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Maximum urethral closure pressure during Valsalva (v-MUCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Valsalva Urethral Profile (VUP) : a New Measure to Assess Stress Urinary Incontinence in Women
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
- Being tested
- Maximum urethral closure pressure during Valsalva (v-MUCP)
- Keywords
- Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| v-MUCP value | Other | All patients referred for urodynamics explorations will have a measure of the MUCP during a Valsalva manoeuver Receives: Diagnostic Test: Maximum urethral closure pressure during Valsalva (v-MUCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start15 Feb 2016
- Primary completion25 Sep 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We conducted a monocentric interventional study, carried out as part of routine care
- Masking
- None (open label)
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Cecile Pizzoferrato, Poissy-Saint Germain Hospital
- Investigators
- Philippe Dompeyre, MD, Principal investigator, Intercommunal Hsopital center of Poissy Saint Germain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311814
- Sponsor's protocol ID
- 2015-A01411-48
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8108659DeLancey 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.
PubMed 8203431DeLancey 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.
PubMed 18423707Bump 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.
PubMed 7645634McGuire 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.
PubMed 8411422Theofrastous 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.
PubMed 7645615Bump 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.
PubMed 8694033Kirschner-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.
PubMed 26872575Avery 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.
PubMed 15227649Messelink 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.
PubMed 15977259Fritel 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.
PubMed 20236751Nager 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.
PubMed 11795644Pizzoferrato 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.
PubMed 28673060Dietz 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.
PubMed 11294530
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valsalva Urethral Profile (VUP) : a New Measure to Assess Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT04311814
- Acronym / sponsor ID
- 2015-A01411-48
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, Urodynamics, Maximal urethral cloture pressure, Bladder neck mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We conducted a monocentric interventional study, carried out as part of routine care
| Arm | Type | Receives |
|---|---|---|
| v-MUCP value | Other | Diagnostic Test: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximum urethral closure pressure during Valsalva (v-MUCP)v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract | Diagnostic test | v-MUCP value |
Primary outcome
Correlation between v-MUCP and diagnosis of SUI
Time frame: 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
Time frame: 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)
Correlation between v-MUCP and VLPP
Time frame: 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
Discrimination capacity of v-MUCP (valsalva Maximal Urethral Closure Pressure, cmH2O) for the diagnosis of SUI (ICIQ = 0 versus ICIQ > 0)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 8108659Petros 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.
- Background: PubMed 8203431DeLancey 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.
- Background: PubMed 18423707DeLancey 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.
- Background: PubMed 7645634Bump 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.
- Background: PubMed 8411422McGuire 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.
- Background: PubMed 7645615Theofrastous 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.
- Background: PubMed 8694033Bump 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.
- Background: PubMed 26872575Kirschner-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.
- Background: PubMed 15227649Avery 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.
- Background: PubMed 15977259Messelink 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.
- Background: PubMed 20236751Fritel 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.
- Background: PubMed 11795644Nager 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Dompeyre, MD principal investigator
Intercommunal Hsopital center of Poissy Saint Germain
Questions about this trial
What is this clinical trial studying?
A study testing Maximum urethral closure pressure during Valsalva (v-MUCP) in people with Stress Urinary Incontinence, run by Poissy-Saint Germain Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between v-MUCP and diagnosis of SUI (time frame: through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311814, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.