Multiple SclerosisNCT03204747
Effect of Need to Void on Gait Speed in Multiple Sclerosis
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
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. 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, Gait
- What is being tested?
- Observational study : gait speed
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 31 Aug 2017
- 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 consulting in a tertiary center in neuro-urology
Who may be able to join
- Multiple sclerosis
- Follow in neuro-urology for lower urinary tract symtpoms
- Able to walk 50 meters without human assistance
- able to hold on void during 3 minutes at least
Who cannot join
- actual urinary tract infection
- relapse in the last week
- Mini Mental State Examination < 10
Trial locations and contacts
1 site in 1 country.
About this study
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. The seconds are due to specific lesion in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that walk and urinary disorders are link, because of similar anatomic ways and control process. Effect of bladder filling is well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown, while medullary integration of these two functions is very close, in medullary cone.
Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link with major walk impairment when patients need to void.
Read more
Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home.
Walk tests are realized in a specific place, with calm and no passage. A chair is placed at each end of the path. Toilets are just next to the hall where they realize the tests. A 10 Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and go is done. Patient can use their habitual walking device. Speed walk asking is comfortable for the two test.
Next, patient can urinate. 3 post void residual volume with portable echography are done, and the higher is recorded.
Patient achieve the same walk tests after urinate, in the same order. They must use the same walking device.
Primary outcome is mean gait recorded for 10 meters walk test.
Secondary outcome is time for timed up and go test.
Individual variability between the 3 10MWT in the two conditions will be study.
Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment will be study in secondary analysis.
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Gait
- Being tested
- Observational study : gait speed
- Keywords
- Gait speed, multiple sclerosis, lower urinary tract symptoms, overactive bladder
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study : gait speedOther
No intervention, only propose water and wait for need to void
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled | Patient with multiple sclerosis and lower urinary tract symptoms, age > 18, able to walk without human help on 50 meters, able to hold urine at least 3 minutes.
A first record of gait will be at strong desire to void. A second record will be after void Gait records consist on : 3 10meter walk test and 1 Timed up and Go test. Receives: Other: Observational study : gait speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Gait speed calculated from 10 meter walk test. Only the 6 intermediate meters are recorded. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated. Mean time is divided by 6 to obtain mean gait speed
Measured: 1 Day: at strong desire to void and just after void
Secondary outcomes (2)
Time for Timed up and Go
1 record is done for timed up and go test after a first training. Time is recorded by a manual chronometer
Measured: 1 Day: at strong desire to void and just after void
Variation of gait speed
Coefficient of variation is calculated from the 3 records of 10 meter walk test. It correspond to standard deviation/average.
Measured: 1 Day: for strong desire to void and post void
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start27 Feb 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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
- 71 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, GREEN GRC-01, Neuro-urology, hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204747
- Sponsor's protocol ID
- P GREEN 001
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Need to Void on Gait Speed in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03204747
- Acronym / sponsor ID
- P GREEN 001
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Gait
- Keywords
- Gait speed, multiple sclerosis, lower urinary tract symptoms, overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 2 Jul 2017 (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.
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. The seconds are due to specific lesion in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that walk and urinary disorders are link, because of similar anatomic ways and control process. Effect of bladder filling is well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown, while medullary integration of these two functions is very close, in medullary cone.
Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link with major walk impairment when patients need to void.
Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home.
Walk tests are realized in a specific place, with calm and no passage. A chair is placed at each end of the path. Toilets are just next to the hall where they realize the tests. A 10 Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and go is done. Patient can use their habitual walking device. Speed walk asking is comfortable for the two test.
Next, patient can urinate. 3 post void residual volume with portable echography are done, and the higher is recorded.
Patient achieve the same walk tests after urinate, in the same order. They must use the same walking device.
Primary outcome is mean gait recorded for 10 meters walk test.
Secondary outcome is time for timed up and go test.
Individual variability between the 3 10MWT in the two conditions will be study.
Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment will be study in secondary analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | Other: Observational study : gait speedPatient with multiple sclerosis and lower urinary tract symptoms, age > 18, able to walk without human help on 50 meters, able to hold urine at least 3 minutes. A first record of gait will be at strong desire to void. A second record will be after void Gait records consist on : 3 10meter walk test and 1 Timed up and Go test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in a tertiary center in neuro-urology
Key inclusion criteria (4 listed)
- Multiple sclerosis
- Follow in neuro-urology for lower urinary tract symtpoms
- Able to walk 50 meters without human assistance
- able to hold on void during 3 minutes at least
Key exclusion criteria (3 listed)
- actual urinary tract infection
- relapse in the last week
- Mini Mental State Examination < 10
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 |
|---|---|---|
| Observational study : gait speedNo intervention, only propose water and wait for need to void | Other | Patients enrolled |
Primary outcome
Gait speed
Time frame: 1 Day: at strong desire to void and just after void
Gait speed calculated from 10 meter walk test. Only the 6 intermediate meters are recorded. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated. Mean time is divided by 6 to obtain mean gait speed
2 secondary outcomes
Time for Timed up and Go
Time frame: 1 Day: at strong desire to void and just after void
Variation of gait speed
Time frame: 1 Day: for strong desire to void and post void
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 19 Jul 2019.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
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
GREEN GRC-01, Neuro-urology, hôpital Tenon
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 4 inclusion and 3 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 19 Jul 2019. 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?
Gait speed (time frame: 1 Day: at strong desire to void and just after void). 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 19 Jul 2019.