Turkish Version of the Neurogenic Bladder Symptom Score Short Form

April 7, 2026 updated by: Bengisu Tüfekçi, Gaziantep Islam Science and Technology University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziantep Islam Science and Technology University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ufuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12024861-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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