Lower Urinary Tract SymptomsNCT03314610
Effect of Need to Void on Parkinsonian Gait
An observational study of Lower Urinary Tract Symptoms and Parkinsonism, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
This study evaluates the effect of the need to void on parkinsonian gait Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Parkinsonism, Gait Disorders, Neurologic
- What is being tested?
- Gait speed
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2017to 30 Dec 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 to 99 years
- 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
- 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
Who cannot join
- Actual urinary tract infection
- Montreal cognitive assessment < 20/30
- Acute psychiatric or neurologic disorders who can interfer with walking tests
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Gait speed
- Medical subject headings
- Lower Urinary Tract Symptoms, Parkinsonian Disorders, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait speedOther
No intervention, only propose water and wait for need to void
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 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. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated.
Measured: [Time Frame: 1 Day: at strong desire to void and just after void]
Secondary outcomes (3)
Time for Timed up and Go
1 record is done for timed up and go test. Time is recorded by a manual chronometer
Measured: [Time Frame: 1 Day: at strong desire to void and just after void]
Time for GMT
1 record is done for GMT , time is recorded by a manual chronometer
Measured: [Time Frame: 1 Day: at strong desire to void and just after void]
Variation of gait speed
Standard deviation and Coefficient of variation is calculated from the 3 records of 10 meter walk test.
Measured: [Time Frame: 1 Day: at strong desire to void and just after void]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start16 Oct 2017
- Primary completion28 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- 11 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
- NCT03314610
- Sponsor's protocol ID
- P. GREEN 001
- Status last verified
- Sep 2019
- First submitted
- 15 Oct 2017
- Last updated
- 25 Sep 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Need to Void on Parkinsonian Gait
- ClinicalTrials.gov ID
- NCT03314610
- Acronym / sponsor ID
- P. GREEN 001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 19 Oct 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | Other: Gait speedPatient 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 |
Who may qualify
- Ages
- 18 to 99 years
- 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)
- 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
Key exclusion criteria (3 listed)
- Actual urinary tract infection
- Montreal cognitive assessment < 20/30
- Acute psychiatric or neurologic disorders who can interfer with walking tests
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 |
|---|---|---|
| Gait speedNo intervention, only propose water and wait for need to void | Other | Patients enrolled |
Primary outcome
Gait Speed
Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]
Gait speed calculated from 10 meter walk test. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated.
3 secondary outcomes
Time for Timed up and Go
Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]
Time for GMT
Time frame: [Time Frame: 1 Day: at strong desire to void and just after void]
Variation of gait speed
Time frame: [Time Frame: 1 Day: at strong desire to void and just after 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 25 Sep 2019.
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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 Lower Urinary Tract Symptoms and Parkinsonism, 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 25 Sep 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: [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 25 Sep 2019.