Effect of Need to Void on Gait Speed in Multiple Sclerosis

NCT03204747 | Completed

• 1 other identifier: P GREEN 001
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Gait

Keywords

Gait speed; multiple sclerosis; lower urinary tract symptoms; overactive bladder

Outcome Measures

Primary Outcomes (1)

• 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

  1 Day: at strong desire to void and just after void

Secondary Outcomes (2)

• Time for Timed up and Go

  1 Day: at strong desire to void and just after void

• Variation of gait speed

  1 Day: for strong desire to void and post void

Study Arms (1)

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

Interventions

Observational study : gait speed OTHER

No intervention, only propose water and wait for need to void

Patients enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in a tertiary center in neuro-urology

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

Service de Neuro-urology, hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gérard Amarenco, PhD

  GREEN GRC-01, Neuro-urology, hôpital Tenon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuro-urology department, Tenon hospital

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: February 27, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

FR (1)