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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964077
• Other study ID #: GaziosmanpasaTREH6
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: January 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study

Description:

Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

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

Locations

Country	Name	City	State
Turkey	Mehmet Akif Guler	Istanbul	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Primary	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.	4 months
Primary	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.	4 months