Spinal Cord InjuriesNCT03964077
Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
An observational study of Spinal Cord Injuries, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Neurogenic Bladder Symptom Score Questionnaire
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 27 Jan 2020
- 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: 70 spinal cord injury patients
Who may be able to join
- Spinal cord injury patients
- aged > 18 years old
Who cannot join
- spinal shock patients
- urinary tract operation in the last month
- Quality of life changes in the last month
- urinary tract infections in the last month
- bladder management changes or drug changes in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study
Read the detailed description
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.
- Conditions
- Spinal Cord Injuries
- Being tested
- Neurogenic Bladder Symptom Score Questionnaire
- Keywords
- Neurogenic Bladder, Quality of life, Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurogenic Bladder Symptom Score QuestionnaireDiagnostic test
Neurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality: Short-form 36
The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 8 domains (using algorithms) (0-100 points). Higher scores show poorer quality of life.
Measured: 4 months
Neurogenic Bladder Symptom Score Questionnaire
Neurogenic Bladder Symptom Score Questionnaire is a 24 item self-reported questionnaire(0-74 points). The questionnaire includes 4 subgroups; incontinence (0-29 points), storage\&voiding (0-22 points) and consequences (0-23 points). Higher the score, the greater the severity of the symptoms.
Measured: 4 months
The King's Health Questionnaire
The King's Health Questionnaire (KHQ) is one of the most widely used for assessing QOL in patients with urinary inkontinence.The KHQ consists of two parts and 32 items [7]. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jun 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964077
- Sponsor's protocol ID
- GaziosmanpasaTREH6
- Status last verified
- Jan 2020
- First submitted
- 22 May 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guler MA, Dogan D, Yilmaz Yalcinkaya E. Validity and reliability of the Turkish version of the neurogenic bladder symptom score. Disabil Rehabil. 2022 Jun;44(12):2889-2895. doi: 10.1080/09638288.2020.1846216. Epub 2020 Nov 24.
PubMed 33232613
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT03964077
- Acronym / sponsor ID
- GaziosmanpasaTREH6
- Conditions
- Spinal Cord Injuries
- Keywords
- Neurogenic Bladder, Quality of life, Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 28 May 2019 (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.
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study
Detailed description
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 spinal cord injury patients
Key inclusion criteria (2 listed)
- Spinal cord injury patients
- aged > 18 years old
Key exclusion criteria (5 listed)
- spinal shock patients
- urinary tract operation in the last month
- Quality of life changes in the last month
- urinary tract infections in the last month
- bladder management changes or drug changes in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurogenic Bladder Symptom Score QuestionnaireNeurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire. | Diagnostic test | – |
Primary outcome
Life quality: Short-form 36
Time frame: 4 months
The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 8 domains (using algorithms) (0-100 points). Higher scores show poorer quality of life.
Neurogenic Bladder Symptom Score Questionnaire
Time frame: 4 months
Neurogenic Bladder Symptom Score Questionnaire is a 24 item self-reported questionnaire(0-74 points). The questionnaire includes 4 subgroups; incontinence (0-29 points), storage\&voiding (0-22 points) and consequences (0-23 points). Higher the score, the greater the severity of the symptoms.
The King's Health Questionnaire
Time frame: 4 months
The King's Health Questionnaire (KHQ) is one of the most widely used for assessing QOL in patients with urinary inkontinence.The KHQ consists of two parts and 32 items [7]. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
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 28 Jan 2020.
- Derived from this study: PubMed 33232613Guler MA, Dogan D, Yilmaz Yalcinkaya E. Validity and reliability of the Turkish version of the neurogenic bladder symptom score. Disabil Rehabil. 2022 Jun;44(12):2889-2895. doi: 10.1080/09638288.2020.1846216. Epub 2020 Nov 24.
- 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 Spinal Cord Injuries, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 5 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 28 Jan 2020. 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?
Life quality: Short-form 36 (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964077, which also lists 1 linked publication.
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 28 Jan 2020.