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NCT04619238 Clinical Trial

Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women

Urinary Incontinence Clinical Trial

Official title:
Reliability of The King's Health Questionnaire and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form in Assessing Urinary Incontinence Effects in Polish Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04619238
Other study ID # 2\2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date January 10, 2019

Study information
Verified date November 2020
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Description:

Purpose The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women. Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA) using VARIMAX rotation was conducted for all questionnaire items. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α). Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland), as well as open source R software (version 3.4.4).

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date January 10, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 82 Years
Eligibility Inclusion Criteria: - informed consent - patients with symptoms of urinary incontinence - age 18-82 years Exclusion Criteria: - lack of consent - inability to understand the study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• King's Health Questionnaire
patients fulfilled questionnaire
• the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
patients fulfilled ICIQ-SF questionnaire

Locations
Country Name City State
Poland Katarzyna Skorupska Lublin

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary psychometric properties of KHQ in polish women with urinary incontinence psychometric properties of KHQ 2017-2018
Primary psychometric properties of ICIQ-SF in polish women with urinary incontinence psychometric properties of ICIQ-SF 2017-2018
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