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

January 27, 2020 updated by: Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

102

Contacts and Locations

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

Study Locations

  • Turkey
    • İ̇stanbul
      • İstanbul, İ̇stanbul, Turkey, 34104
        • Mehmet Akif Guler

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

70 spinal cord injury patients

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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.
4 months
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.
4 months

Collaborators and Investigators

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

Sponsor

Gaziosmanpasa Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2019

Primary Completion (Actual)

January 27, 2020

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREH6

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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