Turkish Version of the Neurogenic Bladder Symptom Score Short Form

NCT07507331 — Completed, 120 participants, Gaziantep Islam Science and Technology University

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

RegistryNCT07507331
StatusCompleted
Study typeObservational
Enrollment120 (Actual)
SponsorGaziantep Islam Science and Technology University (Other); collaborators: Ufuk University
ConditionsNeurogenic Bladder Disorder, Spinal Cord Injury, Multiple Sclerosis, Lower Urinary Track Symptoms
Datesstart 2026-03-27, primary completion 2026-07-22, completion 2026-07-22, first posted 2026-04-02, last updated 2026-07-23
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Neurogenic Bladder Disorder All trials for Spinal Cord Injury

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients diagnosed with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) and neurogenic lower uriAdults with spinal cord injury (SCI) or multiple sclerosis (MS) who have neurogenic lower urinary tract dysfunction will be included. Participants will complete the Turkish version of the Neurogenic Bladder Symptom Score Short Form (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.

+Outcome measures

Primary outcomes

  • Neurogenic Bladder Symptom Score Short Form (NBSS-SF) total score [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

  • King's Health Questionnaire (KHQ) domain scores [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.
  • 12-Item Short Form Health Survey (SF-12) mental and physical health subscale scores [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Hacettepe University Hospital, Neurology Outpatient Clinic and Viransehir State Hospital, Urology Outpatient ClinicAnkara, ÇankayaTurkey (Türkiye)