Urinary IncontinenceNCT05618184
Quality of Life Among Hungarian Women with Urinary Incontinence
An observational study of Urinary Incontinence, run by University of Pecs at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- How many people
- 250 participants
- Where
- 1 siteHungary
- Study dates
- 8 May 2024to 2 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 18 years or older who are able to read and write Hungarian.
Who may be able to join
- Woman
- Age 18 and above
- Providing consent to participate
- Ability to read and write Hungarian
Who cannot join
- Respondents who are unable to complete the online survey due to illiteracy
- Man
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Urinary Incontinence
- Keywords
- Quality of life
- Medical subject headings
- Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (1)
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start8 May 2024
- Primary completion21 Oct 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Márta Hock, Habilitation, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618184
- Sponsor's protocol ID
- BMEÜ/379-3/2022/EKU-2
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Szatmari E, Makai A, Premusz V, Acs P, Hock M. Validation of the Hungarian version of the King's Health Questionnaire (KHQ) in women. Sci Rep. 2026 Apr 24;16(1):19067. doi: 10.1038/s41598-026-49181-z.
PubMed 42031918
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life Among Hungarian Women with Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05618184
- Acronym / sponsor ID
- BMEÜ/379-3/2022/EKU-2
- Conditions
- Urinary Incontinence
- Keywords
- Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years or older who are able to read and write Hungarian.
Key inclusion criteria (4 listed)
- Woman
- Age 18 and above
- Providing consent to participate
- Ability to read and write Hungarian
Key exclusion criteria (2 listed)
- Respondents who are unable to complete the online survey due to illiteracy
- Man
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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.
1 secondary outcome
Short-Form-36
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 42031918Szatmari E, Makai A, Premusz V, Acs P, Hock M. Validation of the Hungarian version of the King's Health Questionnaire (KHQ) in women. Sci Rep. 2026 Apr 24;16(1):19067. doi: 10.1038/s41598-026-49181-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márta Hock, Habilitation principal investigator
University of Pecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation of Incontinence Questionnaire - Short Form (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05618184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.