Urinary IncontinenceNCT05567900
Health Care Seeking Behavior and Knowledge Assessment of Hungarian Women About Pelvic Floor Disorders
An observational study of Urinary Incontinence and Pelvic Organ Prolapse, run by University of Pecs at 1 site in Hungary.
Trial summary
The aim of this study is to assess women's health care seeking behavior and knowledge of urinary incontinence and pelvic organ prolapse and to culturally adapt the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) for the Hungarian population. 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, Pelvic Organ Prolapse, Knowledge, Attitudes, Practice
- How many people
- 596 participants
- Where
- 1 siteHungary
- Study dates
- 4 Mar 2022to 26 Aug 2022
- 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
- Ability to read and write Hungarian
- Willing to complete the online survey
- Providing consent to participate
Who cannot join
- Respondents who had already completed the questionnaire on a prior occasion
- Respondents who unable to complete the online survey due to illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hungarian Women's Health Care Seeking Behavior and Knowledge of Urinary Incontinence and Pelvic Organ Prolapse
The aim of this study is to assess women's health care seeking behavior and knowledge of urinary incontinence and pelvic organ prolapse and to culturally adapt the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) for the Hungarian population.
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse, Knowledge, Attitudes, Practice, Behavior, Health
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse, Behavior, Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence and pelvic organ prolapse knowledge
The Prolapse and Incontinence Knowledge Questionnaire (PIKQ) is used to assess knowledge. It consists of two distinct scales: the first one measures knowledge about urinary incontinence knowledge, while the second one measures knowledge about pelvic organ prolapse. The total score of each scale can range from 0 to 12. Higher scores indicate greater knowledge.
Measured: Baseline
Health seeking behavior
Participants report whether they have sought health care for urinary incontinence. The outcome is the proportion of participants who have ever sought care, among those who reported a history of urinary incontinence.
Measured: Baseline
Secondary outcomes (2)
Urinary incontinence
The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) was used to gather information about the symptoms of urinary incontinence. It contains six questions. The total score can range from 0 to 21. Higher scores indicate more severe symptoms.
Measured: Baseline
Practice of pelvic floor muscle training (PFMT)
The PFMT practice scale of the Pelvic Floor Muscle Training Patient reported Outcome Measures (PFMT-P) was used to assess women's practice of PFMT. Questions dealt with source of knowledge about PFMT, practice and correct performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start4 Mar 2022
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Márta Hock, Habilitation, Study director, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567900
- Sponsor's protocol ID
- BMEÜ/379-3/2022/EKU-1
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hungarian Women's Health Care Seeking Behavior and Knowledge of Urinary Incontinence and Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT05567900
- Acronym / sponsor ID
- BMEÜ/379-3/2022/EKU-1
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse, Knowledge, Attitudes, Practice, Behavior, Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 5 Oct 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 women's health care seeking behavior and knowledge of urinary incontinence and pelvic organ prolapse and to culturally adapt the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) for the Hungarian population.
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 (5 listed)
- Woman
- Age 18 and above
- Ability to read and write Hungarian
- Willing to complete the online survey
- Providing consent to participate
Key exclusion criteria (2 listed)
- Respondents who had already completed the questionnaire on a prior occasion
- Respondents who unable to complete the online survey due to illiteracy
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
Urinary incontinence and pelvic organ prolapse knowledge
Time frame: Baseline
The Prolapse and Incontinence Knowledge Questionnaire (PIKQ) is used to assess knowledge. It consists of two distinct scales: the first one measures knowledge about urinary incontinence knowledge, while the second one measures knowledge about pelvic organ prolapse. The total score of each scale can range from 0 to 12. Higher scores indicate greater knowledge.
Health seeking behavior
Time frame: Baseline
Participants report whether they have sought health care for urinary incontinence. The outcome is the proportion of participants who have ever sought care, among those who reported a history of urinary incontinence.
2 secondary outcomes
Urinary incontinence
Time frame: Baseline
Practice of pelvic floor muscle training (PFMT)
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 22 Jan 2025.
- Individual participant dataSharing planned: No
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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 study director
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 and Pelvic Organ Prolapse, 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 5 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 22 Jan 2025. 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?
Urinary incontinence and pelvic organ prolapse knowledge (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2025.