Multiple SclerosisSEPASNCT04132037
An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- data record
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Sclerosis Patients requiring Intermittent Self Catheterisation
Who may be able to join
- Patient aged 18 to 65 years
- Patient with MS
- First ISC prescription
- Patient giving informed consent
- Patient affiliated to the social security system
Who cannot join
- Patient who has already tried / practiced ISC
- Patient under safeguard of justice / guardianship / tutorship
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.
Read the detailed description
Urinary disorders (UD) are common in Multiple Sclerosis (MS). About 65% of patients suffering from moderate to severe troubles. In case of voiding dysfunction, the reference treatment is based on intermittent self catheterisation (ISC). UD in spinal cord injury (SCI) patients have been widely studied. They are very common, and are life-threatening in the absence of appropriate care. Management of neurological UD (as those occurring in MS) are well defined. ISC is the gold standard of bladder emptying method in this pathological context, and has been the subject of numerous studies. In SCI, the ISC discontinuation rate varies from 52 to 80% according to the published studies, the main factors of continuation being the autonomy to perform the technique, and the continence rate. However, the results are variable. In case of MS, the studies are lacking, the results concerning the discontinuation rate and factors associated with discontinuation are poor. Our main objective within the French speaking neurology study group (GENULF), is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.
This predictive study will be multicenter, observational, analytical, and prospective and will not modify current clinical practice.
We will record clinical and urinary data at each visit (inclusion, 6 weeks, 6 months, 12 months, and 24 months). We will note also if the patient practice ISC as prescribed in order to identify discontinuation of the ISC.
- Conditions
- Multiple Sclerosis
- Being tested
- data record
- Keywords
- Multiple Sclerosis, Urinary disorders, Intermittent Self Catheterisation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data recordOther
Also called questionnaires
At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported
| Study group | Role | What they receive |
|---|---|---|
| patient with multiple sclerosis | At each visit, inclusion, 6 weeks, 6 months, 12 months, and 24 months, the clinical and urinary data will be recorded and the ISC frequency , ISC discontinuation and adherence scale will be evaluated Receives: Other: data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
intermittent self catheterisation discontinuation at 2 years after the start of learning.
intermittent self catheterisation frequency and the adherence scorage will be evaluated for each patient.
Measured: 2 years
Secondary outcomes (3)
intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.
intermittent self catheterisation frequency will be evaluated for each patient.
Measured: 6 WEEKS
intermittent self catheterisation discontinuation 6 months after the start of learning.
intermittent self catheterisation frequency will be evaluated for each patient.
Measured: 6 months
intermittent self catheterisation discontinuation at 1 year after the start of learning.
intermittent self catheterisation frequency will be evaluated for each patient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start26 Jun 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- French Association for Research on Multiple Sclerosis
- Responsible party
- Sponsor
- Investigators
- castel lacanal EVELYNE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132037
- Sponsor's protocol ID
- RC31/18/0354
- Other IDs
- 2019-A00327-50
- Acronym
- SEPAS
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04132037
- Acronym / sponsor ID
- SEPAS / RC31/18/0354
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Urinary disorders, Intermittent Self Catheterisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- French Association for Research on Multiple Sclerosis
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Oct 2019 (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.
Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.
Detailed description
Urinary disorders (UD) are common in Multiple Sclerosis (MS). About 65% of patients suffering from moderate to severe troubles. In case of voiding dysfunction, the reference treatment is based on intermittent self catheterisation (ISC). UD in spinal cord injury (SCI) patients have been widely studied. They are very common, and are life-threatening in the absence of appropriate care. Management of neurological UD (as those occurring in MS) are well defined. ISC is the gold standard of bladder emptying method in this pathological context, and has been the subject of numerous studies. In SCI, the ISC discontinuation rate varies from 52 to 80% according to the published studies, the main factors of continuation being the autonomy to perform the technique, and the continence rate. However, the results are variable. In case of MS, the studies are lacking, the results concerning the discontinuation rate and factors associated with discontinuation are poor. Our main objective within the French speaking neurology study group (GENULF), is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.
This predictive study will be multicenter, observational, analytical, and prospective and will not modify current clinical practice.
We will record clinical and urinary data at each visit (inclusion, 6 weeks, 6 months, 12 months, and 24 months). We will note also if the patient practice ISC as prescribed in order to identify discontinuation of the ISC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with multiple sclerosis | – | Other: data recordAt each visit, inclusion, 6 weeks, 6 months, 12 months, and 24 months, the clinical and urinary data will be recorded and the ISC frequency , ISC discontinuation and adherence scale will be evaluated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis Patients requiring Intermittent Self Catheterisation
Key inclusion criteria (5 listed)
- Patient aged 18 to 65 years
- Patient with MS
- First ISC prescription
- Patient giving informed consent
- Patient affiliated to the social security system
Key exclusion criteria (3 listed)
- Patient who has already tried / practiced ISC
- Patient under safeguard of justice / guardianship / tutorship
- Pregnant or lactating woman
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 |
|---|---|---|
| data recordAlso: questionnairesAt each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported | Other | patient with multiple sclerosis |
Primary outcome
intermittent self catheterisation discontinuation at 2 years after the start of learning.
Time frame: 2 years
intermittent self catheterisation frequency and the adherence scorage will be evaluated for each patient.
3 secondary outcomes
intermittent self catheterisation discontinuation at 6 weeks, after the start of learning.
Time frame: 6 WEEKS
intermittent self catheterisation discontinuation 6 months after the start of learning.
Time frame: 6 months
intermittent self catheterisation discontinuation at 1 year after the start of learning.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Individual participant dataSharing planned: No
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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.
castel lacanal EVELYNE principal investigator
University Hospital, Toulouse
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 Multiple Sclerosis, run by University Hospital, Toulouse 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 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 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?
Results are not available in the source record.
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?
intermittent self catheterisation discontinuation at 2 years after the start of learning. (time frame: 2 years). 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 18 Oct 2019.