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NCT Number: NCT07507331

Turkish Version of the Neurogenic Bladder Symptom Score Short Form

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being ≥18 years old
  • Having a diagnosis of Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) and neurogenic lower urinary tract dysfunction
  • Being able to read and understand Turkish and have the cognitive ability to independently complete questionnaires
  • Can be included with any bladder management method (spontaneous voiding, CIC, permanent catheter, condom catheter, reconstruction/diversion etc.)
  • Volunteering and signing informed consent

Exclusion criteria

  • Having an active urinary tract infection (UTI)
  • Having undergone urological surgery in the last month
  • Reporting changes in bladder/urinary function between the first and second applications (surgery, UTI, change in bladder medication)
  • Having a significant recent change in general health status
  • Having a spinal cord injury (SCI) in the spinal shock phase
  • Having experienced a relapse of Multiple Sclerosis (MS) within the last 3 months.

Treatment and study plan

Primary outcomes

  1. Neurogenic Bladder Symptom Score Short Form (NBSS-SF) total score

    Time frame: 3 months

    The Neurogenic Bladder Symptom Score Short Form (NBSS-SF) is a 10-item patient-reported outcome measure. It will be evaluated in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. The NBSS-SF total symptom score ranges from 0 to 28, with lower scores indicating better symptom status and higher scores indicating worse symptom burden. Domain scores for incontinence, storage and voiding, and consequences will also be assessed. Psychometric evaluation will include internal consistency, test-retest reliability, and convergent validity.

Other outcomes

  1. King's Health Questionnaire (KHQ) domain scores

    Time frame: 3 months

    The King's Health Questionnaire (KHQ) will be used to assess convergent validity of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF). KHQ domain scores will be analyzed, with higher scores indicating worse health-related quality of life and greater symptom impact.

  2. 12-Item Short Form Health Survey (SF-12) mental and physical health subscale scores

    Time frame: 3 months

    The 12-Item Short Form Health Survey (SF-12) will be used to assess convergent validity of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF). Mental and physical health subscale scores will be analyzed separately, with higher scores indicating better health-related quality of life.

Sponsors and collaborators

Lead sponsor

Gaziantep Islam Science and Technology University

Other

Collaborators

  • Ufuk University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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