Multiple SclerosisNCT03336424
Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.
A study testing Non-invasive investigations and Invasive investigations in people with Multiple Sclerosis and Urinary Bladder, Neurogenic, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics
- What is being tested?
- Non-invasive investigations and Invasive investigations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2017to Oct 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- MS with urinary symptoms
Who cannot join
- BPH LUTS
- Bladder cancer
- prostate cancer
- urethral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.
The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.
Read the detailed description
All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly.
An evaluation will be made one month, 3 months and 6 months after the first visit.
- Conditions
- Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics
- Being tested
- Non-invasive investigations, Invasive investigations
- Keywords
- MS, Multiple sclerosis, urinary Bladder, Neurogenic, Urodynamics, Randomized controlled trial
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive investigationsDiagnostic test
Ultrasound, blood tests, urine analysis and culture, uroflowmetry
Invasive investigationsDiagnostic test
Cystomanometry, pressure flow study, EMG
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive investigations group | Experimental | Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry Receives: Diagnostic Test: Non-invasive investigations |
| Invasive investigations group | Experimental | urodynamic study including: cystomanometry, pressure flow study, EMG Receives: Diagnostic Test: Non-invasive investigations; Diagnostic Test: Invasive investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary symptoms
filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother).
Measured: 6 months
urinary quality of life
SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Oct 2017
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie EL HELOU, MD, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336424
- Sponsor's protocol ID
- FM292
- Status last verified
- Sep 2018
- First submitted
- 6 Nov 2017
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.
- ClinicalTrials.gov ID
- NCT03336424
- Acronym / sponsor ID
- FM292
- Conditions
- Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics
- Keywords
- MS, Multiple sclerosis, urinary Bladder, Neurogenic, Urodynamics, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Nov 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.
The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.
Detailed description
All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly.
An evaluation will be made one month, 3 months and 6 months after the first visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
| Arm | Type | Receives |
|---|---|---|
| Non-invasive investigations group | Experimental | Diagnostic Test: Non-invasive investigationsNon-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry |
| Invasive investigations group | Experimental | Diagnostic Test: Non-invasive investigations, Diagnostic Test: Invasive investigationsurodynamic study including: cystomanometry, pressure flow study, EMG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- MS with urinary symptoms
Key exclusion criteria (4 listed)
- BPH LUTS
- Bladder cancer
- prostate cancer
- urethral stenosis
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 |
|---|---|---|
| Non-invasive investigationsUltrasound, blood tests, urine analysis and culture, uroflowmetry | Diagnostic test | Invasive investigations group, Non-invasive investigations group |
| Invasive investigationsCystomanometry, pressure flow study, EMG | Diagnostic test | Invasive investigations group |
Primary outcome
urinary symptoms
Time frame: 6 months
filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother).
urinary quality of life
Time frame: 6 months
SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- 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.
Elie EL HELOU, MD principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive investigations and Invasive investigations in people with Multiple Sclerosis and Urinary Bladder, Neurogenic, run by Saint-Joseph University at 1 site in Lebanon.
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 1 inclusion and 4 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 6 Sep 2018. 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 Lebanon. 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?
urinary symptoms (time frame: 6 months). The study lists 2 primary outcomes in all. 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 6 Sep 2018.