Neurogenic Bladder DisorderNCT07507331
Turkish Version of the Neurogenic Bladder Symptom Score Short Form
An observational study of Neurogenic Bladder Disorder and Spinal Cord Injury, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Disorder, Spinal Cord Injury, Multiple Sclerosis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2026to 22 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted on patients aged ≥18 years with neurogenic LUTS diagnosed with MS or SCI.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Hospital, Neurology Outpatient Clinic and Viransehir State Hospital, Urology Outpatient Clinic
Ankara, Çankaya, 06100
About this study
Official title: Turkish Version of the Neurogenic Bladder Symptom Score Short Form: Cross-Cultural Adaptation and Validation-Reliability Study
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.
Read the 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
- Neurogenic Bladder Disorder, Spinal Cord Injury, Multiple Sclerosis, Lower Urinary Track Symptoms
- Keywords
- Neurogenic Bladder, Neurogenic Bladder Symptom Score- Short Form Validation, Spinal Cord Injury, Multiple Sclerosis
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start27 Mar 2026
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Collaborators
- Ufuk University
- Responsible party
- Principal investigator, Bengisu Tüfekçi, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507331
- Sponsor's protocol ID
- 12024861-53
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Neurogenic Bladder Symptom Score Short Form: Cross-Cultural Adaptation and Validation-Reliability Study
- ClinicalTrials.gov ID
- NCT07507331
- Acronym / sponsor ID
- 12024861-53
- Conditions
- Neurogenic Bladder Disorder, Spinal Cord Injury, Multiple Sclerosis, Lower Urinary Track Symptoms
- Keywords
- Neurogenic Bladder, Neurogenic Bladder Symptom Score- Short Form Validation, Spinal Cord Injury, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Collaborators
- Ufuk University
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on patients aged ≥18 years with neurogenic LUTS diagnosed with MS or SCI.
Key inclusion criteria (5 listed)
- Being ≥18 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder Disorder and Spinal Cord Injury, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurogenic Bladder Symptom Score Short Form (NBSS-SF) total score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.