Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients

January 17, 2024 updated by: University Hospital Ostrava
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Jan Krhut, prof.,MD,PhD
        • Sub-Investigator:
          • Barbora Skugarevská, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with the diagnosis of MS, with or without LUTS.

Description

Inclusion Criteria:

  • diagnosis of multiple sclerosis
  • adult patients
  • signed informed consent

Exclusion Criteria:

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MS with LUTS
Patients with multiple sclerosis with LUTS symptoms.
Other: Structured interview
In-person structured interviews will be performed by the investigators.
MS without LUTS
Patients with multiple sclerosis without LUTS symptoms.
Other: Structured interview
In-person structured interviews will be performed by the investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour of structured interview

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of disease (clinical examination)
Time Frame: 5 years
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).
5 years
Course of disease (EDSS scale)
Time Frame: 5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Jan Krhut, prof.,MD, PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make the individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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