Multiple SclerosisNCT04928716
Multiple Sclerosis and Voiding Symptoms: How to Assess?
An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Voiding Disorders
- What is being tested?
- voiding phase evaluation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple sclerosis consulting for a first urodynamic evaluation without urinary treatment were included
Who may be able to join
- Multiple sclerosis (Mc Donalds criterias 2017)
- performing an urodynamic evaluation
Who cannot join
- patients with urinary treatment
Trial locations and contacts
1 site in 1 country.
About this study
In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.
This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.
Read more
This prospective observational study was conducted in a neuro-urology department of a French university hospital.
All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes.
Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected.
For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.
Read the detailed description
Lower urinary tract (LUT) dysfunctions are common in multiple sclerosis (MS) with almost all the patients reporting LUT symptoms at 10 years of duration of MS.LUT dysfunctions affect one patient out of ten at the time of the first neurological symptoms and negatively impact patients' quality of life.
In MS, storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended to perform pressure flow studies to assess voiding phase. In 2018, the ICS defined altered sphincter function and detrusor function during pressure flow studies in neurogenic LUT dysfunction. Three types of sphincter dysfunctions are reported: detrusor-sphincter dyssynergia (DSD) defined as "a detrusor contraction concurrent with an involuntary contraction of the urethral and/or periurethral striated muscle. Occasionally flow may be prevented altogether." , non-relaxing urethral sphincter as "a non-relaxing, obstructing urethral sphincter resulting in reduced urine flow" and delayed relaxation of the urethral sphincter as "an impaired and hindered relaxation of the sphincter during voiding attempt resulting in delay of urine flow". Regarding detrusor dysfunction during voiding phase, two types are reported: Neurogenic detrusor underactivity (DUA) defined as "a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or a failure to achieve complete bladder emptying within a normal time span in the setting of a clinically relevant neurologic disorder", neurogenic acontractile detrusor "is one that cannot be demonstrated to contract during urodynamic studies in the setting of a clinically relevant neurologic lesion". In studies in MS patients undergoing urodynamic testing, this classification was not used. First because these definitions are recent, secondly because assessing sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.
This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.
This prospective observational study was conducted in a neuro-urology department of a French university hospital.
All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed in order to identify contractility of the detrusor. Anal sphincter activity was recorded during the urodynamic testing using surface electromyography electrodes. Urodynamic evaluation was realized in accordance with ICS recommendation.
Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale (EDSS), urinary symptoms using the Urinary Symptom Profile (USP) and the Neurogenic Bladder Symptom Score (NBSS) were collected.
Detrusor contractility assessment.
For assessment of detrusor contractility on patients with neurological disease, the following parameters are reported: (i) the bladder voiding efficiency (BVE) defined as a percentage (BVE= (voided volume/total bladder capacity) x 100) ; (ii) the projected isovolumetric pressure (PIP) or bladder contractility index (BCI) given by the formula BCI=PdetQmax + 5Qmax with a strong contractility if BCI >150, normal contractility if BCI of 100-150 and weak contractility if BCI <100 ; (iii) the Watts factor (WF) = [(Pdet + a)(vdet + b) - ab]/2π where Pdet is the detrusor pressure, vdet is the velocity of detrusor contraction, and a (25 cmH2O) and b (0.6 cm/s) are back-calculated muscle constants representing the heat of shortening and the rate of energy liberation, respectively.
For women, the investigators presented 3 more parameters (i) the PIP1= PdetQmax + Qmax ; (ii) the Valentini-besson-Nelson (VBN) parameter k (simulating detrusor force) and (iii) an urodynamic cut-off proposed by Gammie et al. for DUA with PdetQmax <20; Qmax <15, and BVE <90%.
The conclusions of the detrusor contractility assessment were reported. This conclusion was made with a double reading of the urodynamic curves: the first assessment was made by the physician who initially received the patient; a second reading of the pressure-flow studies was made in blind by CC.
Bladder outlet obstruction was assessed with the Bladder Obstruction outlet index (BOOI). Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.
- Being tested
- voiding phase evaluation
- Keywords
- multiple sclerosis, Lower Urinary Tract Symptoms, voiding disorders, neurogenic bladder, urodynamics
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voiding phase evaluationOther
Assessment of voiding phase in multiple sclerosis patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the voiding phase
assessment of the voiding phase in multiple sclerosis patients with description of the existing parameters in urodynamic tests
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PHD, Principal investigator, Sorbonne Université, GRC 001, GREEN Groupe de Recherche en Neuro-Urologie, AP-HP, Hôpital Tenon, F-75020, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928716
- Sponsor's protocol ID
- GRC 01 GREEN
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis and Voiding Symptoms: How to Assess?
- ClinicalTrials.gov ID
- NCT04928716
- Acronym / sponsor ID
- GRC 01 GREEN
- Keywords
- multiple sclerosis, Lower Urinary Tract Symptoms, voiding disorders, neurogenic bladder, urodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 16 Jun 2021 (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.
In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.
This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.
This prospective observational study was conducted in a neuro-urology department of a French university hospital.
All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes.
Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected.
For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.
Detailed description
Lower urinary tract (LUT) dysfunctions are common in multiple sclerosis (MS) with almost all the patients reporting LUT symptoms at 10 years of duration of MS.LUT dysfunctions affect one patient out of ten at the time of the first neurological symptoms and negatively impact patients' quality of life.
In MS, storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended to perform pressure flow studies to assess voiding phase. In 2018, the ICS defined altered sphincter function and detrusor function during pressure flow studies in neurogenic LUT dysfunction. Three types of sphincter dysfunctions are reported: detrusor-sphincter dyssynergia (DSD) defined as "a detrusor contraction concurrent with an involuntary contraction of the urethral and/or periurethral striated muscle. Occasionally flow may be prevented altogether." , non-relaxing urethral sphincter as "a non-relaxing, obstructing urethral sphincter resulting in reduced urine flow" and delayed relaxation of the urethral sphincter as "an impaired and hindered relaxation of the sphincter during voiding attempt resulting in delay of urine flow". Regarding detrusor dysfunction during voiding phase, two types are reported: Neurogenic detrusor underactivity (DUA) defined as "a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or a failure to achieve complete bladder emptying within a normal time span in the setting of a clinically relevant neurologic disorder", neurogenic acontractile detrusor "is one that cannot be demonstrated to contract during urodynamic studies in the setting of a clinically relevant neurologic lesion". In studies in MS patients undergoing urodynamic testing, this classification was not used. First because these definitions are recent, secondly because assessing sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.
This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.
This prospective observational study was conducted in a neuro-urology department of a French university hospital.
All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed in order to identify contractility of the detrusor. Anal sphincter activity was recorded during the urodynamic testing using surface electromyography electrodes. Urodynamic evaluation was realized in accordance with ICS recommendation.
Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale (EDSS), urinary symptoms using the Urinary Symptom Profile (USP) and the Neurogenic Bladder Symptom Score (NBSS) were collected.
Detrusor contractility assessment.
For assessment of detrusor contractility on patients with neurological disease, the following parameters are reported: (i) the bladder voiding efficiency (BVE) defined as a percentage (BVE= (voided volume/total bladder capacity) x 100) ; (ii) the projected isovolumetric pressure (PIP) or bladder contractility index (BCI) given by the formula BCI=PdetQmax + 5Qmax with a strong contractility if BCI >150, normal contractility if BCI of 100-150 and weak contractility if BCI <100 ; (iii) the Watts factor (WF) = [(Pdet + a)(vdet + b) - ab]/2π where Pdet is the detrusor pressure, vdet is the velocity of detrusor contraction, and a (25 cmH2O) and b (0.6 cm/s) are back-calculated muscle constants representing the heat of shortening and the rate of energy liberation, respectively.
For women, the investigators presented 3 more parameters (i) the PIP1= PdetQmax + Qmax ; (ii) the Valentini-besson-Nelson (VBN) parameter k (simulating detrusor force) and (iii) an urodynamic cut-off proposed by Gammie et al. for DUA with PdetQmax <20; Qmax <15, and BVE <90%.
The conclusions of the detrusor contractility assessment were reported. This conclusion was made with a double reading of the urodynamic curves: the first assessment was made by the physician who initially received the patient; a second reading of the pressure-flow studies was made in blind by CC.
Bladder outlet obstruction was assessed with the Bladder Obstruction outlet index (BOOI). Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple sclerosis consulting for a first urodynamic evaluation without urinary treatment were included
Key inclusion criteria (2 listed)
- Multiple sclerosis (Mc Donalds criterias 2017)
- performing an urodynamic evaluation
Key exclusion criteria (1 listed)
- patients with urinary treatment
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 |
|---|---|---|
| voiding phase evaluationAssessment of voiding phase in multiple sclerosis patients | Other | – |
Primary outcome
Description of the voiding phase
Time frame: 1 day
assessment of the voiding phase in multiple sclerosis patients with description of the existing parameters in urodynamic tests
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 23 Jun 2021.
- 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.
Gérard Amarenco, PHD principal investigator
Sorbonne Université, GRC 001, GREEN Groupe de Recherche en Neuro-Urologie, AP-HP, Hôpital Tenon, F-75020, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Pierre and Marie Curie University at 1 site in France.
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 1 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Description of the voiding phase (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2021.