NCT06599866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

September 12, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

lower urinary tract symptomsmultiple sclerosisreliabilityvalidity

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minuttes

Secondary Outcomes (1)

  • Overactive Bladder Questionnaire-V8

    5 minutes

Study Arms (1)

Multiple Sclerosis Group

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Center, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple SclerosisLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

May 15, 2024

Primary Completion

January 15, 2025

Study Completion

March 26, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations