Clinical trial NCT03314610: Effect of Need to Void on Parkinsonian Gait
Official title: Effect of Need to Void on Parkinsonian Gait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Parkinsonism
Gait Disorders, Neurologic
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in a tertiary center in neuro-urology

Brief summary: This study evaluates the effect of the need to void on parkinsonian gait

Detailed description: Parkinsonian syndromes are common causes of gait disorders, associated with hypometria, bradykinesia or rigidity. If motor disorders are the most visible part, lower urinary tract dysfunction is one of the most prevalent dysautonomic disorder (27-80%), especially over active bladder syndrome (OAB). If it seems evident that gait and urinary disorders are linked, because of similar anatomic pathways and control processes, no studies have investigated their association in extrapyramidal patients.

The aim of this study is to assess the effect of the need to void on the walking speed in this particular population.

This prospective study inclues all parkinsonian syndromes who had a follow-up for OAB. They must have a security delay over five minutes, no severe cognitive, motor or psychiatric disorders. We invite them to drink until a need to void (or equivalent). Bladder filling is measured by bladder scan, then they performe gait tests in a specific place, with calm and no passage : Patient can use their habitual walking device. Speed walk asking is comfortable for the two test. Three ten-meter tests, one double-task ten-meter test, one timed-up-and-go test, one timed raise of the floor (GMT). We repeat the same tests after voiding or self-catheterization. Toilets are just next to the hall where they realize the tests. A clinical examination assesses urinary dysfunction (USP, IPSS), motor score (UPDRS-III, Hoehn and Yahr scale, daily equivalent of levodopa), history of falls and comorbidities.

Eligibility criteria: Inclusion Criteria:

* Parkinsonian syndromes
* Follow in neurourology for Lower urinary tract symptoms
* Able to walk 50 meters without human assistance
* able to hold voiding for more than 3 minutes

Exclusion Criteria:

* Actual urinary tract infection
* Montreal cognitive assessment \< 20/30
* Acute psychiatric or neurologic disorders who can interfer with walking tests

Primary outcomes:
measure: Gait Speed
timeFrame: [Time Frame: 1 Day: at strong desire to void and just after void]
Secondary outcomes:
measure: Time for Timed up and Go
timeFrame: [Time Frame: 1 Day: at strong desire to void and just after void]
measure: Time for GMT
timeFrame: [Time Frame: 1 Day: at strong desire to void and just after void]
measure: Variation of gait speed
timeFrame: [Time Frame: 1 Day: at strong desire to void and just after void]
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Neuro-urology, hôpital Tenon
Study officials:
affiliation: GREEN GRC-01, Neuro-urology, hôpital Tenon
name: Gérard Amarenco, PhD
role: PRINCIPAL_INVESTIGATOR
References: