FallNCT04338646
Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis
An observational study of Fall and Multiple Sclerosis, run by Gérard Amarenco at 1 site in France.
Trial summary
Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall, Multiple Sclerosis, Lower Urinary Tract Symptoms
- What is being tested?
- Clinical tests
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 30 Apr 2020
- 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 years and older
- 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
- age ≥ 18 years
- Multiple sclerosis (MS) diagnosis
- Lower urinary tract symptoms with or without treatment,
- Expanded Disability Status Scale score between 1 and 6.5
Who cannot join
- relapse of MS in the past month
- urinary tract infection the day of inclusion
- impossibility to complete the symptoms' questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.
The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.
Read more
Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.
The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).
The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.
- Conditions
- Fall, Multiple Sclerosis, Lower Urinary Tract Symptoms
- Being tested
- Clinical tests
- Keywords
- Fall, multiple sclerosis, lower urinary tract symptoms, overactive bladder
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical testsOther
Questionnaire about urinary symptoms, gait difficulties, fear of falling. Clinical test: Time to be Ready to Void
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled | Patient with multiple sclerosis and lower urinary tract symptoms, age >18 Expanded Disability Status Scale score between 1 and 6.5 Receives: Other: Clinical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls in the past 3 months
Patients were asked about the number of falls in the past three months, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia)
Measured: 1 day
Secondary outcomes (1)
Number of falls in the past year
Patients were asked about the number of falls in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Jul 2019
- Primary completion15 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérard Amarenco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PhD, Principal investigator, Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338646
- Sponsor's protocol ID
- GREEN GRC01 P
- Status last verified
- Feb 2022
- First submitted
- 4 Apr 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hentzen C, Villaume A, Turmel N, Chesnel C, Le Breton F, Haddad R, Amarenco G. Are falls in people with multiple sclerosis related to the severity of urinary disorders? Ann Phys Rehabil Med. 2021 Jul;64(4):101452. doi: 10.1016/j.rehab.2020.10.006. Epub 2020 Dec 5.
PubMed 33186783
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04338646
- Acronym / sponsor ID
- GREEN GRC01 P
- Conditions
- Fall, Multiple Sclerosis, Lower Urinary Tract Symptoms
- Keywords
- Fall, multiple sclerosis, lower urinary tract symptoms, overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 8 Apr 2020 (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.
Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.
The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.
Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.
The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).
The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | Other: Clinical testsPatient with multiple sclerosis and lower urinary tract symptoms, age >18 Expanded Disability Status Scale score between 1 and 6.5 |
Who may qualify
- Ages
- 18 years and older
- 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)
- age ≥ 18 years
- Multiple sclerosis (MS) diagnosis
- Lower urinary tract symptoms with or without treatment,
- Expanded Disability Status Scale score between 1 and 6.5
Key exclusion criteria (3 listed)
- relapse of MS in the past month
- urinary tract infection the day of inclusion
- impossibility to complete the symptoms' questionnaires
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 |
|---|---|---|
| Clinical testsQuestionnaire about urinary symptoms, gait difficulties, fear of falling. Clinical test: Time to be Ready to Void | Other | Patients enrolled |
Primary outcome
Number of falls in the past 3 months
Time frame: 1 day
Patients were asked about the number of falls in the past three months, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia)
1 secondary outcome
Number of falls in the past year
Time frame: 1 day
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 18 Feb 2022.
- Derived from this study: PubMed 33186783Hentzen C, Villaume A, Turmel N, Chesnel C, Le Breton F, Haddad R, Amarenco G. Are falls in people with multiple sclerosis related to the severity of urinary disorders? Ann Phys Rehabil Med. 2021 Jul;64(4):101452. doi: 10.1016/j.rehab.2020.10.006. Epub 2020 Dec 5.
- Individual participant dataSharing planned: Undecided
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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
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
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 Fall and Multiple Sclerosis, run by Gérard Amarenco 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 18 Feb 2022. 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?
Number of falls in the past 3 months (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338646, which also lists 1 linked publication.
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 18 Feb 2022.