Quality of Life Among Hungarian Women with Urinary Incontinence

December 8, 2024 updated by: University of Pecs

Health-related Quality of Life Among Hungarian Women with Urinary Incontinence

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

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

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7621
        • University of Pecs

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 years or older who are able to read and write Hungarian.

Description

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 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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation of Incontinence Questionnaire - Short Form
Time Frame: Baseline
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
King's Health Questionnaire
Time Frame: Baseline
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
Incontinence Impact Questionnaire short form
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Form-36
Time Frame: Baseline

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

Collaborators and Investigators

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

Sponsor

University of Pecs

Investigators

  • Principal Investigator: Márta Hock, Habilitation, University of Pecs

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)

May 8, 2024

Primary Completion (Actual)

October 21, 2024

Study Completion (Actual)

December 2, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMEÜ/379-3/2022/EKU-2

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

product manufactured in and exported from the U.S.

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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