Lower Urinary Tract SymptomsNCT06226831
Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients
An observational study of Lower Urinary Tract Symptoms and Multiple Sclerosis, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Retrospective, non-interventional case-control study, the patients were asked about their first lower-urinary tract symptoms and the date of their onset, using a structured interview. The information was matched with the medical records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms, Multiple Sclerosis
- What is being tested?
- Structured interview
- How many people
- 1,500 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2020to Dec 2025
- 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
- Adult, Older adult
Study population: Patients with the diagnosis of MS, with or without LUTS.
Who may be able to join
- diagnosis of multiple sclerosis
- adult patients
- signed informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Jan Krhut, prof.,MD,PhD
About this study
Retrospective, non-interventional case-control study, the patients were asked about their first lower-urinary tract symptoms and the date of their onset, using a structured interview. The information was matched with the medical records.
Read the detailed description
This retrospective non-interventional case-control study will be conducted at a single tertiary referral Multidisciplinary Centre for Diagnostics and Treatment of MS at the University Hospital, Ostrava, Czech Republic. The study will be performed per the Declaration of Helsinki, World Health Organization. The study protocol has been approved by the Ethics Committee of University Hospital Ostrava, Nr.289/19.
The database of the Center includes medical records of all consecutive patients, who have visited the center at least once, starting from 1996 until the present day. Based on the inclusion criteria of proven multiple sclerosis (MS) diagnosis and the current age over 18 years, the initial database search identified eligible 2348 individuals. During the routine follow-up visit of the patients at the Center, a structured in-person interview led by a physician will be performed.
The data from this interview will be cross-checked with the medical records. In addition to standard demographic variables, the following data will be obtained:
Age 1 - Age at the onset of the first symptoms of MS Age 2 - Age at the time of diagnosis of MS Age 3 - Age at the time of data collection MS course - patients with a primary progressive, secondary progressive, or progressive relapsing disease at the time of data collection will be included in the group "Progressive MS course". The "Relapsing-remitting MS course" group will include patients who had a relapsing-remitting disease and those with isolated clinical symptoms at the time of data collection.
CPS - The "CPS yes" group will include patients who experienced cerebellar and/or pyramidal symptoms (CPS) as the first manifestation of MS. Patients with other first manifestations, such as optic neuritis, sensory disturbances, etc., will be included in the "CPS no" group.
OCB - The "OCB yes" group will include patients with oligoclonal bands (OCB) in the cerebrospinal fluid at the time of diagnosis of MS. Patients in whom OCB in the cerebrospinal fluid at the time of diagnosis of MS will not be identified, will be assigned to the "OCB no" group.
LUTS - The "LUTS yes" group will include patients with the presence of at least one LUTS at the time of the structured interview. In this group, a complete list of LUTS with layman descriptions will be given to each patient. The patients will be asked to indicate, which of the lower urinary tract symptoms (LUTS) occurred as the very first one. The "LUTS no" group will include patients without LUTS.
EDSS 1 - The Expanded Disability Status Scale (EDSS) total score will be collected after stabilization following the first MS relapse before the disease-specific treatment will be initiated, and will be defined as the baseline EDSS at the time of MS diagnosis.
EDSS 2 - EDSS at the time of first onset of LUTS. D1- duration of MS symptoms, i.e. time elapsed since the onset of first symptoms attributable to MS.
D2 - MS disease duration, i.e. the time elapsed since the diagnosis of MS will be determined.
D3 - duration of LUTS, i.e. the time elapsed since the first LUTS appeared.
Based on the above-mentioned data, collected during the interview, the researchers will calculate the following variables:
T1 - Time between the presentation of first symptoms attributable to MS and the onset of first LUTS (T1= D1-D3) T2 -Time between the diagnosis of MS and the onset of first LUTS (T2= D2-D3)
Based on LUTS presence and its relationship to the time of diagnosis of MS, the patients will be divided into 3 groups:
Group A - Patients in whom LUTS appeared after the first neurological symptom which could be attributed to the MS has developed and diagnosis of MS was established; Group B - Patients who have not developed LUTS yet; Group C - Patients in whom LUTS appeared before the diagnosis of MS was established.
STATISTICAL ANALYSIS Numerical variables will be expressed as the median and the interquartile range. Categorical variables will be presented as the absolute frequencies and relative frequencies in percentages. Defined groups will be compared using the Mann-Whitney test, the Kruskal-Wallis test, or the Chi-square test of independence for contingency tables. The first two mentioned tests will be also used to test the difference between other subgroups of interest. The statistical dependence of two numerical variables will be tested and evaluated using Spearman's rank correlation coefficient and its test of significance. The univariate logistic regression will be used to assess the significance of selected factors in relation to the development of LUTS. The results will be presented with the odds ratios and corresponding confidence intervals and will be visualized using the forest plot. Finally, the methods of survival analysis - the Kaplan-Meier curve and the Cox proportional-hazards model, will be used for the analysis of survival without LUTS. All statistical analyses will be performed using R software (version 4.0.2, www.r-project.org) and the significance level will be set to 0.05.
- Conditions
- Lower Urinary Tract Symptoms, Multiple Sclerosis
- Being tested
- Structured interview
- Keywords
- Multiple Sclerosis, Lower-Urinary Tract Symptoms, Urinary Urgency, Cerebellar and/or Pyramidal Symptoms
- Medical subject headings
- Lower Urinary Tract Symptoms, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured interviewOther
In-person structured interviews will be performed by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| MS with LUTS | Patients with multiple sclerosis with LUTS symptoms. Receives: Other: Structured interview | |
| MS without LUTS | Patients with multiple sclerosis without LUTS symptoms. Receives: Other: Structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUTS onset
The time of LUTS onset in relation to the diagnosis of MS diagnosis (before or after) will be observed in months, during the structured interviews with the study subjects.
Measured: 1 hour of structured interview
Secondary outcomes (2)
Course of disease (clinical examination)
The course of disease (primary-progressive, secondary-progressive) will be observed, defined by the presence or absence of cerebro-pyramidal symptoms (YES/NO - defined with clinical examination).
Measured: 5 years
Course of disease (EDSS scale)
The course of disease (primary-progressive, secondary-progressive) will be observed, defined by the presence or absence of cerebro-pyramidal symptoms (defined by the Kurtzke Expanded Disability Status Scale (EDSS)). The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jun 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Krhut, prof.,MD, PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226831
- Sponsor's protocol ID
- MS001
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make the individual participant data available to other researchers. The data may be provided upon request.
Publications
Dilokthornsakul P, Valuck RJ, Nair KV, Corboy JR, Allen RR, Campbell JD. Multiple sclerosis prevalence in the United States commercially insured population. Neurology. 2016 Mar 15;86(11):1014-21. doi: 10.1212/WNL.0000000000002469. Epub 2016 Feb 17.
PubMed 26888980Rosati G. The prevalence of multiple sclerosis in the world: an update. Neurol Sci. 2001 Apr;22(2):117-39. doi: 10.1007/s100720170011.
PubMed 11603614Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262Nortvedt MW, Riise T, Myhr KM, Landtblom AM, Bakke A, Nyland HI. Reduced quality of life among multiple sclerosis patients with sexual disturbance and bladder dysfunction. Mult Scler. 2001 Aug;7(4):231-5. doi: 10.1177/135245850100700404.
PubMed 11548982Khalaf KM, Coyne KS, Globe DR, Malone DC, Armstrong EP, Patel V, Burks J. The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis. Neurourol Urodyn. 2016 Jan;35(1):48-54. doi: 10.1002/nau.22670. Epub 2014 Oct 18.
PubMed 25327401Khalaf KM, Coyne KS, Globe DR, Armstrong EP, Malone DC, Burks J. Lower urinary tract symptom prevalence and management among patients with multiple sclerosis. Int J MS Care. 2015 Jan-Feb;17(1):14-25. doi: 10.7224/1537-2073.2013-040.
PubMed 25741223Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.
PubMed 32410904Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
PubMed 24871874KURTZKE JF. A new scale for evaluating disability in multiple sclerosis. Neurology. 1955 Aug;5(8):580-3. doi: 10.1212/wnl.5.8.580. No abstract available.
PubMed 13244774Medina-Polo J, Adot JM, Allue M, Arlandis S, Blasco P, Casanova B, Matias-Guiu J, Madurga B, Meza-Murillo ER, Muller-Arteaga C, Rodriguez-Acevedo B, Vara J, Zubiaur MC, Lopez-Fando L. Consensus document on the multidisciplinary management of neurogenic lower urinary tract dysfunction in patients with multiple sclerosis. Neurourol Urodyn. 2020 Feb;39(2):762-770. doi: 10.1002/nau.24276. Epub 2020 Jan 15.
PubMed 31943361Krhut J, Hradilek P, Zapletalova O. Analysis of the upper urinary tract function in multiple sclerosis patients. Acta Neurol Scand. 2008 Aug;118(2):115-9. doi: 10.1111/j.1600-0404.2008.00992.x. Epub 2008 Feb 25.
PubMed 18307573Phe V, Pakzad M, Curtis C, Porter B, Haslam C, Chataway J, Panicker JN. Urinary tract infections in multiple sclerosis. Mult Scler. 2016 Jun;22(7):855-61. doi: 10.1177/1352458516633903. Epub 2016 Feb 18.
PubMed 26892318Correale J, Fiol M, Gilmore W. The risk of relapses in multiple sclerosis during systemic infections. Neurology. 2006 Aug 22;67(4):652-9. doi: 10.1212/01.wnl.0000233834.09743.3b. Epub 2006 Jul 26.
PubMed 16870812
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06226831
- Acronym / sponsor ID
- MS001
- Conditions
- Lower Urinary Tract Symptoms, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Lower-Urinary Tract Symptoms, Urinary Urgency, Cerebellar and/or Pyramidal Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jan 2024 (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.
Retrospective, non-interventional case-control study, the patients were asked about their first lower-urinary tract symptoms and the date of their onset, using a structured interview. The information was matched with the medical records.
Detailed description
This retrospective non-interventional case-control study will be conducted at a single tertiary referral Multidisciplinary Centre for Diagnostics and Treatment of MS at the University Hospital, Ostrava, Czech Republic. The study will be performed per the Declaration of Helsinki, World Health Organization. The study protocol has been approved by the Ethics Committee of University Hospital Ostrava, Nr.289/19.
The database of the Center includes medical records of all consecutive patients, who have visited the center at least once, starting from 1996 until the present day. Based on the inclusion criteria of proven multiple sclerosis (MS) diagnosis and the current age over 18 years, the initial database search identified eligible 2348 individuals. During the routine follow-up visit of the patients at the Center, a structured in-person interview led by a physician will be performed.
The data from this interview will be cross-checked with the medical records. In addition to standard demographic variables, the following data will be obtained:
Age 1 - Age at the onset of the first symptoms of MS Age 2 - Age at the time of diagnosis of MS Age 3 - Age at the time of data collection MS course - patients with a primary progressive, secondary progressive, or progressive relapsing disease at the time of data collection will be included in the group "Progressive MS course". The "Relapsing-remitting MS course" group will include patients who had a relapsing-remitting disease and those with isolated clinical symptoms at the time of data collection.
CPS - The "CPS yes" group will include patients who experienced cerebellar and/or pyramidal symptoms (CPS) as the first manifestation of MS. Patients with other first manifestations, such as optic neuritis, sensory disturbances, etc., will be included in the "CPS no" group.
OCB - The "OCB yes" group will include patients with oligoclonal bands (OCB) in the cerebrospinal fluid at the time of diagnosis of MS. Patients in whom OCB in the cerebrospinal fluid at the time of diagnosis of MS will not be identified, will be assigned to the "OCB no" group.
LUTS - The "LUTS yes" group will include patients with the presence of at least one LUTS at the time of the structured interview. In this group, a complete list of LUTS with layman descriptions will be given to each patient. The patients will be asked to indicate, which of the lower urinary tract symptoms (LUTS) occurred as the very first one. The "LUTS no" group will include patients without LUTS.
EDSS 1 - The Expanded Disability Status Scale (EDSS) total score will be collected after stabilization following the first MS relapse before the disease-specific treatment will be initiated, and will be defined as the baseline EDSS at the time of MS diagnosis.
EDSS 2 - EDSS at the time of first onset of LUTS. D1- duration of MS symptoms, i.e. time elapsed since the onset of first symptoms attributable to MS.
D2 - MS disease duration, i.e. the time elapsed since the diagnosis of MS will be determined.
D3 - duration of LUTS, i.e. the time elapsed since the first LUTS appeared.
Based on the above-mentioned data, collected during the interview, the researchers will calculate the following variables:
T1 - Time between the presentation of first symptoms attributable to MS and the onset of first LUTS (T1= D1-D3) T2 -Time between the diagnosis of MS and the onset of first LUTS (T2= D2-D3)
Based on LUTS presence and its relationship to the time of diagnosis of MS, the patients will be divided into 3 groups:
Group A - Patients in whom LUTS appeared after the first neurological symptom which could be attributed to the MS has developed and diagnosis of MS was established; Group B - Patients who have not developed LUTS yet; Group C - Patients in whom LUTS appeared before the diagnosis of MS was established.
STATISTICAL ANALYSIS Numerical variables will be expressed as the median and the interquartile range. Categorical variables will be presented as the absolute frequencies and relative frequencies in percentages. Defined groups will be compared using the Mann-Whitney test, the Kruskal-Wallis test, or the Chi-square test of independence for contingency tables. The first two mentioned tests will be also used to test the difference between other subgroups of interest. The statistical dependence of two numerical variables will be tested and evaluated using Spearman's rank correlation coefficient and its test of significance. The univariate logistic regression will be used to assess the significance of selected factors in relation to the development of LUTS. The results will be presented with the odds ratios and corresponding confidence intervals and will be visualized using the forest plot. Finally, the methods of survival analysis - the Kaplan-Meier curve and the Cox proportional-hazards model, will be used for the analysis of survival without LUTS. All statistical analyses will be performed using R software (version 4.0.2, www.r-project.org) and the significance level will be set to 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS with LUTS | – | Other: Structured interviewPatients with multiple sclerosis with LUTS symptoms. |
| MS without LUTS | – | Other: Structured interviewPatients with multiple sclerosis without LUTS symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of MS, with or without LUTS.
Key inclusion criteria (3 listed)
- diagnosis of multiple sclerosis
- adult patients
- signed informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Structured interviewIn-person structured interviews will be performed by the investigators. | Other | MS with LUTS, MS without LUTS |
Primary outcome
LUTS onset
Time frame: 1 hour of structured interview
The time of LUTS onset in relation to the diagnosis of MS diagnosis (before or after) will be observed in months, during the structured interviews with the study subjects.
2 secondary outcomes
Course of disease (clinical examination)
Time frame: 5 years
Course of disease (EDSS scale)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 26888980Dilokthornsakul P, Valuck RJ, Nair KV, Corboy JR, Allen RR, Campbell JD. Multiple sclerosis prevalence in the United States commercially insured population. Neurology. 2016 Mar 15;86(11):1014-21. doi: 10.1212/WNL.0000000000002469. Epub 2016 Feb 17.
- Background: PubMed 11603614Rosati G. The prevalence of multiple sclerosis in the world: an update. Neurol Sci. 2001 Apr;22(2):117-39. doi: 10.1007/s100720170011.
- Background: PubMed 12559262Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Background: PubMed 11548982Nortvedt MW, Riise T, Myhr KM, Landtblom AM, Bakke A, Nyland HI. Reduced quality of life among multiple sclerosis patients with sexual disturbance and bladder dysfunction. Mult Scler. 2001 Aug;7(4):231-5. doi: 10.1177/135245850100700404.
- Background: PubMed 25327401Khalaf KM, Coyne KS, Globe DR, Malone DC, Armstrong EP, Patel V, Burks J. The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis. Neurourol Urodyn. 2016 Jan;35(1):48-54. doi: 10.1002/nau.22670. Epub 2014 Oct 18.
- Background: PubMed 25741223Khalaf KM, Coyne KS, Globe DR, Armstrong EP, Malone DC, Burks J. Lower urinary tract symptom prevalence and management among patients with multiple sclerosis. Int J MS Care. 2015 Jan-Feb;17(1):14-25. doi: 10.7224/1537-2073.2013-040.
- Background: PubMed 32410904Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.
- Background: PubMed 24871874Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
- Background: PubMed 13244774KURTZKE JF. A new scale for evaluating disability in multiple sclerosis. Neurology. 1955 Aug;5(8):580-3. doi: 10.1212/wnl.5.8.580. No abstract available.
- Background: PubMed 31943361Medina-Polo J, Adot JM, Allue M, Arlandis S, Blasco P, Casanova B, Matias-Guiu J, Madurga B, Meza-Murillo ER, Muller-Arteaga C, Rodriguez-Acevedo B, Vara J, Zubiaur MC, Lopez-Fando L. Consensus document on the multidisciplinary management of neurogenic lower urinary tract dysfunction in patients with multiple sclerosis. Neurourol Urodyn. 2020 Feb;39(2):762-770. doi: 10.1002/nau.24276. Epub 2020 Jan 15.
- Background: PubMed 18307573Krhut J, Hradilek P, Zapletalova O. Analysis of the upper urinary tract function in multiple sclerosis patients. Acta Neurol Scand. 2008 Aug;118(2):115-9. doi: 10.1111/j.1600-0404.2008.00992.x. Epub 2008 Feb 25.
- Background: PubMed 26892318Phe V, Pakzad M, Curtis C, Porter B, Haslam C, Chataway J, Panicker JN. Urinary tract infections in multiple sclerosis. Mult Scler. 2016 Jun;22(7):855-61. doi: 10.1177/1352458516633903. Epub 2016 Feb 18.
- Individual participant dataSharing planned: No. There is no plan to make the individual participant data available to other researchers. The data may be provided upon request.
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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.
Jan Krhut, prof.,MD, PhD principal investigator
University Hospital Ostrava
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 Multiple Sclerosis, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 1 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 26 Jan 2024. 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 Czechia. 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?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUTS onset (time frame: 1 hour of structured interview). 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 NCT06226831, which also lists 13 linked publications.
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 26 Jan 2024.