Urinary IncontinenceNCT04619238
Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women
An observational study of Urinary Incontinence and Overactive Bladder, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women. Read more about this study
- Who is it for?
- Ages 18 to 82 years, women only
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder, Stress Urinary Incontinence
- What is being tested?
- King's Health Questionnaire and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
- How many people
- 155 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2017to 10 Jan 2019
- 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 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women age 18-82 years who declared symptoms of urinary incontinence
Who may be able to join
- informed consent
- patients with symptoms of urinary incontinence
- age 18-82 years
Who cannot join
- lack of consent
- inability to understand the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of The King's Health Questionnaire and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form in Assessing Urinary Incontinence Effects in Polish Women
The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.
Read the detailed description
Purpose The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.
Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA) using VARIMAX rotation was conducted for all questionnaire items. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α). Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland), as well as open source R software (version 3.4.4).
- Being tested
- King's Health Questionnaire, the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
- Keywords
- king's health questionnaire, the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King's Health QuestionnaireDiagnostic test
patients fulfilled questionnaire
the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short FormDiagnostic test
patients fulfilled ICIQ-SF questionnaire
| Study group | Role | What they receive |
|---|---|---|
| no urinary incontinence | patients without UI Receives: Diagnostic Test: King's Health Questionnaire; Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form | |
| stress urinary incontinence | patients with SUI Receives: Diagnostic Test: King's Health Questionnaire; Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form | |
| overactive bladder | patients with OAB Receives: Diagnostic Test: King's Health Questionnaire; Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form | |
| mix urinary incontinence | patients with MUI Receives: Diagnostic Test: King's Health Questionnaire; Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form | |
| Urge | patients with urge incontinence Receives: Diagnostic Test: King's Health Questionnaire; Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychometric properties of KHQ in polish women with urinary incontinence
psychometric properties of KHQ
Measured: 2017-2018
psychometric properties of ICIQ-SF in polish women with urinary incontinence
psychometric properties of ICIQ-SF
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jun 2017
- Primary completion30 Dec 2018
- Study completion10 Jan 2019
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Skorupska, Medical University of Lublin
- Investigators
- Tomasz Rechberger, Professor, Study director, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619238
- Sponsor's protocol ID
- 2\2020
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of The King's Health Questionnaire and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form in Assessing Urinary Incontinence Effects in Polish Women
- ClinicalTrials.gov ID
- NCT04619238
- Acronym / sponsor ID
- 2\2020
- Keywords
- king's health questionnaire, the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 6 Nov 2020 (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 was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.
Detailed description
Purpose The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.
Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA) using VARIMAX rotation was conducted for all questionnaire items. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α). Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland), as well as open source R software (version 3.4.4).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| no urinary incontinence | – | Diagnostic Test: King's Health Questionnaire, Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients without UI |
| stress urinary incontinence | – | Diagnostic Test: King's Health Questionnaire, Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients with SUI |
| overactive bladder | – | Diagnostic Test: King's Health Questionnaire, Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients with OAB |
| mix urinary incontinence | – | Diagnostic Test: King's Health Questionnaire, Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients with MUI |
| Urge | – | Diagnostic Test: King's Health Questionnaire, Diagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients with urge incontinence |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women age 18-82 years who declared symptoms of urinary incontinence
Key inclusion criteria (3 listed)
- informed consent
- patients with symptoms of urinary incontinence
- age 18-82 years
Key exclusion criteria (2 listed)
- lack of consent
- inability to understand the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| King's Health Questionnairepatients fulfilled questionnaire | Diagnostic test | Urge, mix urinary incontinence, no urinary incontinence, overactive bladder, stress urinary incontinence |
| the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Formpatients fulfilled ICIQ-SF questionnaire | Diagnostic test | Urge, mix urinary incontinence, no urinary incontinence, overactive bladder, stress urinary incontinence |
Primary outcome
psychometric properties of KHQ in polish women with urinary incontinence
Time frame: 2017-2018
psychometric properties of KHQ
psychometric properties of ICIQ-SF in polish women with urinary incontinence
Time frame: 2017-2018
psychometric properties of ICIQ-SF
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 6 Nov 2020.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
Tomasz Rechberger, Professor study director
Medical University of Lublin
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 Overactive Bladder, run by Medical University of Lublin at 1 site in Poland.
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 3 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 6 Nov 2020. 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 Poland. 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?
psychometric properties of KHQ in polish women with urinary incontinence (time frame: 2017-2018). 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 6 Nov 2020.