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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05618184
Other study ID # BMEÜ/379-3/2022/EKU-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2022
Est. completion date July 10, 2024

Study information

Verified date May 2024
Source University of Pecs
Contact Eva Szatmari, Master's
Phone +40746727417
Email szatmarieva05@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the prevalence of urinary incontinence among Hungarian women. In addition to that, we aim evaluate the health related quality of life among Hungarian women with urinary incontinence and to culturally adapt the following questionnaires for the Hungarian population: Incontinence Impact Questionnaire - Short Form (IIQ-7) and King's Health Questionnaire (KHQ).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 10, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Woman - Age 18 and above - Providing consent to participate - Ability to read and write Hungarian Exclusion Criteria: - Respondents who are unable to complete the online survey due to illiteracy - Man

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hungary University of Pécs Pécs Baranya

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Consultation of Incontinence Questionnaire - Short Form The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) will be used to gather information about the symptoms of urinary incontinence. It contains six questions. The total score can range from 0 to 21, with higher scores suggesting more severe symptoms. Baseline
Primary King's Health Questionnaire The King's Health Questionnaire (KHQ) will be used to measure the impact of urinary incontinence on the subject's health related quality of life. It assesses quality of life in nine different domains of life. Each domain is scored separately ranging from 0 (best) to 100 (worst). Baseline
Primary Incontinence Impact Questionnaire short form The Incontinence Impact Questionnaire short form (IIQ-7) will be also used to measure the impact of urinary incontinence on the subject's health related quality of life. It is comprised of seven questions. The total score ranges from 0 to 21, with higher scores indicating more severe symptoms and worse quality of life. Baseline
Secondary Short-Form-36 The Short-Form-36 (SF-36) will be used to measure the generic health-related quality of life of participants. It consists of 35 individual questions and it is divided into eight domains of health.
The total score ranges from 0 (worst health state) to 100 (best health state).
Baseline
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