NCT03964077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

May 22, 2019

Last Update Submit

January 27, 2020

Conditions

Keywords

Neurogenic BladderQuality of lifeSpinal Cord Injury

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Interventions

Neurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

70 spinal cord injury patients

You may qualify if:

  • Spinal cord injury patients
  • aged \> 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif Guler

Istanbul, İ̇stanbul, 34104, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 28, 2019

Study Start

June 1, 2019

Primary Completion

January 27, 2020

Study Completion

January 27, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations