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Effect of Need to Void on Gait Speed in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03204747
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

Brief 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. 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.


Condition or disease Intervention/treatment
Multiple Sclerosis Lower Urinary Tract Symptoms Gait Other: Observational study : gait speed

Study Type : Observational
Estimated Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Need to Void on Gait Speed in Multiple Sclerosis
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Other: Observational study : gait speed
No intervention, only propose water and wait for need to void




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time for Timed up and Go [ Time Frame: 1 Day: at strong desire to void and just after void ]
    1 record is done for timed up and go test after a first training. Time is recorded by a manual chronometer

  2. Variation of gait speed [ Time Frame: 1 Day: for strong desire to void and post void ]
    Coefficient of variation is calculated from the 3 records of 10 meter walk test. It correspond to standard deviation/average.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting in a tertiary center in neuro-urology
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • actual urinary tract infection
  • relapse in the last week
  • Mini Mental State Examination < 10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204747


Contacts
Contact: Claire Hentzen, Resident +33156017040 greengrc01@gmail.com
Contact: Gérard Amarenco, PhD +33156017040 greengrc01@gmail.com

Locations
France
Service de Neuro-urology, hôpital Tenon Recruiting
Paris, France, 75020
Contact: Claire Hentzen, Resident    +33156017040    greengrc01@gmail.com   
Contact: Gérard Amarenco, PhD    +33156017040    greengrc01@gmail.com   
Principal Investigator: Gérard Amarenco, PhD         
Sub-Investigator: Claire Hentzen, Resident         
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
Principal Investigator: Gérard Amarenco, PhD GREEN GRC-01, Neuro-urology, hôpital Tenon

Responsible Party: Gérard Amarenco, Head of Neuro-urology department, Tenon hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT03204747     History of Changes
Other Study ID Numbers: P GREEN 001
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gérard Amarenco, Pierre and Marie Curie University:
Gait speed
multiple sclerosis
lower urinary tract symptoms
overactive bladder

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Lower Urinary Tract Symptoms
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urological Manifestations
Signs and Symptoms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors