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Not Yet RecruitingNCT07507331

Turkish Version of the Neurogenic Bladder Symptom Score Short Form

Turkish Version of the Neurogenic Bladder Symptom Score Short Form: Cross-Cultural Adaptation and Validation-Reliability Study

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Gaziantep Islam Science and Technology University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This observational study aims to evaluate the cross-cultural adaptation and psychometric properties of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. Neurogenic bladder symptoms, such as urinary incontinence, urgency, and difficulties with urine storage or emptying, may negatively affect daily functioning and quality of life. In this study, the validity and reliability of the Turkish NBSS-SF will be examined, and convergent validity will be assessed through its relationship with the King's Health Questionnaire (KHQ) and the Short Form-12 (SF-12). In eligible participants, the scale will be administered again after 7 to 14 days. The aim of the study is to provide a valid and reliable Turkish patient-reported outcome measure for use in clinical practice and research.

Detailed description

This is a methodological, cross-sectional, observational study designed to develop the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) and to evaluate its psychometric properties in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. The study will include translation, cross-cultural adaptation, pilot testing, and validation phases. The Turkish adaptation process will consist of forward translation, reconciliation, backward translation, and expert committee review. The pre-final Turkish version will then be tested in approximately 30 participants to evaluate item clarity and acceptability. After the necessary linguistic revisions, the final Turkish version will be produced. The target sample size for the validation phase is 120 participants. Eligible participants will be adults aged 18 years or older with a diagnosis of spinal cord injury or multiple sclerosis, neurogenic lower urinary tract dysfunction, and sufficient cognitive ability to read and complete the questionnaires in Turkish independently. Individuals with an active urinary tract infection, urological surgery within the last month, spinal shock, a recent significant change in general health status, or a relapse within the last 3 months in the case of multiple sclerosis will be excluded. During data collection, participants will complete a case report form, the Turkish NBSS-SF, the King's Health Questionnaire (KHQ), and the Short Form-12 (SF-12). In clinically stable eligible participants, the Turkish NBSS-SF will be re-administered after 7 to 14 days to assess test-retest reliability. Psychometric evaluation will include assessment of internal consistency using Cronbach's alpha, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity by examining the relationships between NBSS-SF scores and KHQ and SF-12 scores. The study aims to produce a valid and reliable short-form Turkish patient-reported outcome measure for the evaluation of neurogenic bladder symptoms in clinical practice and research.

Conditions

Timeline

Start date
2026-03-27
Primary completion
2026-04-01
Completion
2026-05-01
First posted
2026-04-02
Last updated
2026-04-13

Source: ClinicalTrials.gov record NCT07507331. Inclusion in this directory is not an endorsement.