Quality of Life Among Hungarian Women With Urinary Incontinence

Sponsor

University of Pecs (Other)

Overall Status

Recruiting

CT.gov ID

NCT05618184

Collaborator

(none)

200

Enrollment

Location

20.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 7, 2022

Anticipated Primary Completion Date :

Jul 10, 2024

Anticipated Study Completion Date :

Jul 10, 2024

Outcome Measures

Primary Outcome Measures

International Consultation of Incontinence Questionnaire - Short Form [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.
King's Health Questionnaire [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).
Incontinence Impact Questionnaire short form [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.

Secondary Outcome Measures

Short-Form-36 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pécs	Pécs	Baranya	Hungary	7621

Sponsors and Collaborators

University of Pecs

Investigators

Principal Investigator: Márta Hock, Habilitation, University of Pecs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pecs

ClinicalTrials.gov Identifier:

NCT05618184

Other Study ID Numbers:

BMEÜ/379-3/2022/EKU-2

First Posted:

Nov 16, 2022

Last Update Posted:

Nov 16, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pecs

Quality of life

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Nov 16, 2022