Lower Urinary Track SymptomsNCT06599866
Turkish Validity and Reliability of the Core Lower Urinary Tract Symptoms Questionnaire in Individuals With Multiple Sclerosis
An observational study of Lower Urinary Track Symptoms and Multiple Sclerosis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to study the validity and reliability of Core Lower Urinary Tract Symptoms Score in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Urinary Track Symptoms, Multiple Sclerosis
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 26 Mar 2025
- How long will I take part?
- 1 Week
- 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: Being diagnosed with multiple sclerosis by a specialist physician between the ages of 18-65.
Who may be able to join
- Being between 18-65 years old
- Being diagnosed with multiple sclerosis by a specialist
- Being willing to participate in the study
- Being literate
Who cannot join
- Not volunteering to participate in the study
- Having a neurological disorder that prevents speech
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Center
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Urinary Track Symptoms, Multiple Sclerosis
- Keywords
- lower urinary tract symptoms, multiple sclerosis, reliability, validity
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Group | Individuals between the ages of 18-65 who have been diagnosed with multiple sclerosis by a specialist physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Lower Urinary Tract Symptoms Score
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.
Measured: 10 minuttes
Secondary outcomes (1)
Overactive Bladder Questionnaire-V8
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 May 2024
- Primary completion15 Jan 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Track SymptomsStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe 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
- 71 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599866
- Sponsor's protocol ID
- 2024/04-13
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiloatar H, Delibay AA, Demir CO, Ceylan D, Uysal N. Reliability and validity of the Turkish version of the core lower urinary tract symptom score in multiple sclerosis. Acta Neurol Belg. 2025 Jun;125(3):811-817. doi: 10.1007/s13760-025-02769-0. Epub 2025 Mar 26.
PubMed 40133731
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Core Lower Urinary Tract Symptoms Questionnaire in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06599866
- Acronym / sponsor ID
- 2024/04-13
- Conditions
- Lower Urinary Track Symptoms, Multiple Sclerosis
- Keywords
- lower urinary tract symptoms, multiple sclerosis, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 19 Sep 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.
The aim of this study is to study the validity and reliability of Core Lower Urinary Tract Symptoms Score in patients with multiple sclerosis.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Group | – | –Individuals between the ages of 18-65 who have been diagnosed with multiple sclerosis by a specialist physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Being diagnosed with multiple sclerosis by a specialist physician between the ages of 18-65.
Key inclusion criteria (4 listed)
- Being between 18-65 years old
- Being diagnosed with multiple sclerosis by a specialist
- Being willing to participate in the study
- Being literate
Key exclusion criteria (2 listed)
- Not volunteering to participate in the study
- Having a neurological disorder that prevents speech
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Overactive Bladder Questionnaire-V8
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 40133731Kiloatar H, Delibay AA, Demir CO, Ceylan D, Uysal N. Reliability and validity of the Turkish version of the core lower urinary tract symptom score in multiple sclerosis. Acta Neurol Belg. 2025 Jun;125(3):811-817. doi: 10.1007/s13760-025-02769-0. Epub 2025 Mar 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Track Symptoms and Multiple Sclerosis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Core Lower Urinary Tract Symptoms Score (time frame: 10 minuttes). 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 NCT06599866, which also lists 1 linked publication.
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 5 Sep 2025.