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出境医 / 临床实验 / Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
Study Description
Brief Summary:
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study
| Condition or disease | Intervention/treatment |
|---|---|
| Spinal Cord Injuries | Diagnostic Test: Neurogenic Bladder Symptom Score Questionnaire |
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
| Study Type : | Observational |
| Actual Enrollment : | 102 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | January 27, 2020 |
| Actual Study Completion Date : | January 27, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 22, 2019 | ||||
| First Posted Date | May 28, 2019 | ||||
| Last Update Posted Date | January 28, 2020 | ||||
| Actual Study Start Date | June 1, 2019 | ||||
| Actual Primary Completion Date | January 27, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study | ||||
| Official Title | Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study | ||||
| Brief Summary | 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 Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 70 spinal cord injury patients | ||||
| Condition | Spinal Cord Injuries | ||||
| Intervention | Diagnostic Test: Neurogenic Bladder Symptom Score Questionnaire
Neurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
102 | ||||
| Original Estimated Enrollment |
70 | ||||
| Actual Study Completion Date | January 27, 2020 | ||||
| Actual Primary Completion Date | January 27, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03964077 | ||||
| Other Study ID Numbers | GaziosmanpasaTREH6 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital | ||||
| Study Sponsor | Gaziosmanpasa Research and Education Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Gaziosmanpasa Research and Education Hospital | ||||
| Verification Date | January 2020 | ||||
