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Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study

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ClinicalTrials.gov Identifier: NCT03964077
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital

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.

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Study Type : Observational
Estimated Enrollment : 70 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
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Neurogenic Bladder Symptom Score Questionnaire
    Neurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire.


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
70 spinal cord injury patients
Criteria

Inclusion Criteria:

  • Spinal cord injury patients
  • aged > 18 years old

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964077


Contacts
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Contact: Mehmet Guler +905054930098 makifguler89@gmail.com

Locations
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Turkey
Mehmet Akif Guler Recruiting
İstanbul, İ̇stanbul, Turkey, 34104
Contact: Mehmet Guler, M.D.    5054930098    makifguler89@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital

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Responsible Party: Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT03964077     History of Changes
Other Study ID Numbers: GaziosmanpasaTREH6
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital:
Neurogenic Bladder
Quality of life
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms