ClinicalTrials.gg
CompletedNCT03314610Updated Sep 25, 2019

Effect of Need to Void on Parkinsonian Gait

An observational study in Lower Urinary Tract Symptoms, Parkinsonism and Gait Disorders, Neurologic, sponsored by Pierre and Marie Curie University. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Pierre and Marie Curie University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Lower Urinary Tract Symptoms with a site in France — 5 open to participants now, 6 under way, none of them phase 3. Lower Urinary Tract Symptoms · France.

Enrollment
14th of 15
11 · median 72
Started
2017
with 5 others
Observational
15 of 26
1 open now
Registered
10th of 26
by date
Lead sponsor
7 of 26
Pierre and Marie Curie University

Among the 26 studies in Lower Urinary Tract Symptoms with a site in France, this one is the 14th largest by enrollment of the 15 observational ones that give a count, is one of 6 that started in 2017, is one of 15 observational ones, and was the 10th registered.

Lower Urinary Tract Symptoms

417 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

Browse Lower Urinary Tract Symptoms studies →

Open to participants now

5 of the 26 studies in Lower Urinary Tract Symptoms with a site in France are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Lower Urinary Tract Symptoms
  • Parkinsonism
  • Gait Disorders, Neurologic
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients consulting in a tertiary center in neuro-urology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Actual urinary tract infection
  • \< 20/30
  • Acute psychiatric or neurologic disorders who can interfer with walking tests
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients enrolled

    Patient with parkinsonian syndromes 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 speed will be at strong desire to void. A second record will be after voiding or catheterization Gait records consist on : 3x 10 meter walk test, 1x double task 10 meter walk test, 1x Timed up and Go test and 1x GMT

    Other: Gait speed

Interventions

  • OtherGait speed

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

06

What researchers measure

Primary outcomes

  1. Gait Speed

    Gait speed calculated from 10 meter walk test. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated.

    Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]

Secondary outcomes

  1. Time for Timed up and Go

    1 record is done for timed up and go test. Time is recorded by a manual chronometer

    Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]

  2. Time for GMT

    1 record is done for GMT , time is recorded by a manual chronometer

    Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]

  3. Variation of gait speed

    Standard deviation and Coefficient of variation is calculated from the 3 records of 10 meter walk test.

    Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]

07

Study locations

1 site
  • Service de Neuro-urology, hôpital Tenon
    Paris, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2017, 2 months.

Of 56 non-industry observational studies under Lower Urinary Tract Symptoms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 70. This study's 2 months is below that.

Counting every sponsor, half of 61 studies reached it within 33 months; a quarter within 11 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2017
First posted
Oct 19, 2017
StartActual
Oct 16, 2017
Primary completionActual
Dec 28, 2017
CompletionActual
Dec 30, 2017
Last update
Sep 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03314610
Lead sponsor
Pierre and Marie Curie University
Responsible party
Gérard Amarenco (Head of Neuro-Urology Department, Tenon Hospital, Pierre and Marie Curie University) — Principal investigator
First posted
Oct 19, 2017
Start date
Oct 16, 2017
Primary completion
Dec 28, 2017
Completion
Dec 30, 2017
Last update
Sep 25, 2019

Study contacts

Gérard Amarenco, PhD
principal investigator · GREEN GRC-01, Neuro-urology, hôpital Tenon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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