Turkish Validity and Reliability of the Core Lower Urinary Tract Symptoms Questionnaire in Individuals With Multiple Sclerosis

September 4, 2025 updated by: Kutahya Health Sciences University

Turkish Validity and Reliability of the Core Lower Urinary Tract Symptoms Questionnaire in Patients With Multiple Sclerosis

The aim of this study is to study the validity and reliability of Core Lower Urinary Tract Symptoms Score in patients with multiple sclerosis.

Study Overview

Status

Completed

Conditions

Detailed Description

Multiple sclerosis is an autoimmune disease that can affect any part of the central nervous system. Multiple sclerosis, whose prevalence is increasing every year in the world, brings with it many symptoms. Lower urinary tract symptoms develop secondary to demyelinating lesions in the spinal cord and pontine micturition center in the disease pathophysiology commonly seen in Multiple sclerosis and other symptoms seen in Multiple sclerosis (inactivity, fear of movement, etc.). Due to the multifocal and widespread involvement of the CNS, Lower urinary tract symptoms in Multiple sclerosis patients are variable and their severity varies among Multiple sclerosis patients. Lower urinary tract symptoms are divided into 3 groups as storage, voiding and post-voiding symptoms. The rate of urinary complications in Multiple sclerosis patients is significantly higher compared to the general population. Although it is a common symptom in multiple sclerosis , the evaluation of Lower urinary tract symptoms in individuals with Multiple sclerosis is quite limited in the literature. Evaluation of Lower urinary tract symptoms seen in Multiple sclerosis with appropriate assessment tools is important to obtain comprehensive information about the progression of the disease. There are many questionnaires used in the evaluation of Lower urinary tract symptoms. While the International Prostate Symptom Score and the Danish Prostate Symptom Score, which are frequently used for benign prostatic hyperplasia, are used; Overactive Bladder Questionnaire-V8 was developed to evaluate overactive bladder symptoms. However, these questionnaires are also frequently used in the evaluation of Lower urinary tract symptoms. Since the purpose of developing the questionnaires is for different diseases, they are not comprehensive enough for Lower urinary tract symptoms. The Core Lower Urinary Tract Symptoms Score is a questionnaire developed to comprehensively evaluate lower urinary tract symptoms. Although the Core Lower Urinary Tract Symptoms Score Turkish validity and reliability study was conducted by Erbay et al. in 2022, its validity and reliability in Multiple sclerosis patients has not been performed.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
    • Center
      • Kütahya, Center, Turkey (Türkiye)
        • Kutahya Health Sciences University

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

No

Sampling Method

Non-Probability Sample

Study Population

Being diagnosed with multiple sclerosis by a specialist physician between the ages of 18-65.

Description

Inclusion Criteria:

  • Being between 18-65 years old
  • Being diagnosed with multiple sclerosis by a specialist
  • Being willing to participate in the study
  • Being literate

Exclusion Criteria:

  • Not volunteering to participate in the study
  • Having a neurological disorder that prevents speech

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
Multiple Sclerosis Group
Individuals between the ages of 18-65 who have been diagnosed with multiple sclerosis by a specialist physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Lower Urinary Tract Symptoms Score
Time Frame: 10 minuttes
The questionnaire was developed by Homma et al. in 2008 to assess lower urinary tract symptoms. The Turkish validity and reliability study of the questionnaire was conducted by Erbay et al. in 2022. The first 5 questions in the 13-question questionnaire are about storage problems, the next 3 questions are about urination problems, and the next 2 questions are about lower urinary tract pain. The first 10 questions are scored on a Likert-type scale from 0 to 3. The Core Lower Urinary Tract also includes a question asking participants to list three core symptoms (question 11) and a question about the primary core symptom (question 12). It also includes a question about quality of life (question 13). The last question is about the patients' satisfaction with their current urinary status, scored from 0 to 6.
10 minuttes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Questionnaire-V8
Time Frame: 5 minutes
Overactive Bladder Questionnaire was first developed in English by Coyne and colleagues in 2002. In later studies, Overactive Bladder Questionnaire short form and shorter forms such as Overactive Bladder Questionnaire-V8 were developed. Overactive Bladder Questionnaire-V8 consists of the first 8 questions of Overactive Bladder Questionnaire and was recommended as an Overactive Bladder Questionnaire screening and awareness test. The validity and reliability of the questionnaire in Turkish was conducted by Tarcan et al. in 2012. Today, it is frequently used to evaluate lower urinary tract symptoms. The Overactive Bladder Questionnaire-V8 uses a Likert-type scale of 0-5 to determine the severity of individuals' complaints: None (0); a little (1); a little (2); a lot (3); a lot (4); a lot (5). The total score is between 0 and 40. If the total score obtained from the questionnaire is more than 8, individuals are considered to have possible lower urinary tract symptoms.
5 minutes

Collaborators and Investigators

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

Sponsor

Kutahya Health Sciences University

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)

May 15, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

March 26, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/04-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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