NCT07507331

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

March 27, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

Neurogenic BladderNeurogenic Bladder Symptom Score- Short Form ValidationSpinal Cord InjuryMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

    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.

    3 months

Other Outcomes (2)

  • King's Health Questionnaire (KHQ) domain scores

    3 months

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

    3 months

Study Arms (1)

Patients diagnosed with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) and neurogenic lower uri

Adults 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.

Eligibility Criteria

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

The study will be conducted on patients aged ≥18 years with neurogenic LUTS diagnosed with MS or SCI.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital, Neurology Outpatient Clinic and Viransehir State Hospital, Urology Outpatient Clinic

Ankara, Çankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicSpinal Cord InjuriesMultiple Sclerosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

March 27, 2026

Primary Completion

July 22, 2026

Study Completion

July 22, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations