- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619238
Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women
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
Study Overview
Status
Detailed 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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lublin, Poland, 20-059
- Katarzyna Skorupska
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
no urinary incontinence
patients without UI
|
patients fulfilled questionnaire
patients fulfilled ICIQ-SF questionnaire
|
stress urinary incontinence
patients with SUI
|
patients fulfilled questionnaire
patients fulfilled ICIQ-SF questionnaire
|
overactive bladder
patients with OAB
|
patients fulfilled questionnaire
patients fulfilled ICIQ-SF questionnaire
|
mix urinary incontinence
patients with MUI
|
patients fulfilled questionnaire
patients fulfilled ICIQ-SF questionnaire
|
Urge
patients with urge incontinence
|
patients fulfilled questionnaire
patients fulfilled ICIQ-SF questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychometric properties of KHQ in polish women with urinary incontinence
Time Frame: 2017-2018
|
psychometric properties of KHQ
|
2017-2018
|
psychometric properties of ICIQ-SF in polish women with urinary incontinence
Time Frame: 2017-2018
|
psychometric properties of ICIQ-SF
|
2017-2018
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tomasz Rechberger, Professor, Medical University of Lublin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2\2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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