Validity of Thai Version of the ICIQ-FLUTS LF QuestionnaireNCT06270849
Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS
An observational study of Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire and Reliability of Thai Version of the ICIQ-FLUTS LF, run by Thammasat University Hospital at 1 site in Thailand.
Trial summary
The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire, Reliability of Thai Version of the ICIQ-FLUTS LF
- What is being tested?
- Questionnaire
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- 24 Feb 2023to 20 Jan 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females with lower urinary tract symptoms who can read and understand Thai language.
Who may be able to join
- age at or over 18 years old
- can read and understand Thai language
- have lower urinary tract symptoms
Who cannot join
- those who have a diagnosis of calculi, urinary tract cancer
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Validity and Reliability of the Translated International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) in Thai Version and Correlation With the IPSS
The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis.
Read the detailed description
50 females with LUTS will completed the ICIQ-FLUTS and IPSS and then again at 2 weeks apart to test for convergent validity and test-retest validity.
The normal control group 80 women will completed ICIQ-FLUTS LF for test of construct validity.
- Conditions
- Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire, Reliability of Thai Version of the ICIQ-FLUTS LF
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The questionnaire to assess severity of LUTS in women.
| Study group | Role | What they receive |
|---|---|---|
| Female with LUTS | Females who has symptoms of lower urinary tract symptoms Receives: Other: Questionnaire | |
| Normal control group | Females who no history of LUTS or urinary tract disease Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity.
Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) was divided into 6 subgroups of symptoms measurement, which were storage, voiding, incontinence, bladder pain, post micturition, and ability to stop voiding. The construct validity was determined by comparing the ICIQ-FLUTS LF scores of the target group with the ICIQ-FLUTS LF scores of the control group. The comparisons were performed using the Wilcoxon signed-rank test.
Measured: 10-12 months
The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency.
The internal consistency (a parameter that verifies correlations between items within a subscale of the questionnaire) was assessed by using Cronbach's alpha coefficients. The assessment was done in each subscale of the questionnaire. If Cronbach's alpha coefficients were between 0.7 and 0.95, the instrument was considered to have good internal consistency.
Measured: 10-12 months
The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability.
The test-retest reliability (a property of producing repeated measurements that are consistent) was verified by having the participants of the target group answer the questionnaire twice with an interval of 2 weeks between the evaluations. We calculated test-retest reliability by using weighted kappa (κ).
Measured: 10-12 months
Secondary outcomes (1)
The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity.
The convergent validity (how closely a test is related to other tests that measure the same or similar constructs) was determined by comparing the ICIQ-FLUTS LF scores of the target group with a known validated questionnaire. In this study we used the International Prostate Symptom Score (IPSS) as the comparison test. The comparisons were performed using Pearson's correlation.
Measured: 10-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start24 Feb 2023
- Primary completion31 Dec 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validity of Thai Version of the ICIQ-FLUTS LF QuestionnaireStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeerat Swatesutipun, Thammasat University Hospital
- Investigators
- Valeerat Swatesutipun, MD, Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270849
- Sponsor's protocol ID
- MTU-EC-SU-0-002/66
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Translated International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) in Thai Version and Correlation With the IPSS
- ClinicalTrials.gov ID
- NCT06270849
- Acronym / sponsor ID
- MTU-EC-SU-0-002/66
- Conditions
- Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire, Reliability of Thai Version of the ICIQ-FLUTS LF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (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 investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis.
Detailed description
50 females with LUTS will completed the ICIQ-FLUTS and IPSS and then again at 2 weeks apart to test for convergent validity and test-retest validity.
The normal control group 80 women will completed ICIQ-FLUTS LF for test of construct validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female with LUTS | – | Other: QuestionnaireFemales who has symptoms of lower urinary tract symptoms |
| Normal control group | – | Other: QuestionnaireFemales who no history of LUTS or urinary tract disease |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females with lower urinary tract symptoms who can read and understand Thai language.
Key inclusion criteria (3 listed)
- age at or over 18 years old
- can read and understand Thai language
- have lower urinary tract symptoms
Key exclusion criteria (1 listed)
- those who have a diagnosis of calculi, urinary tract cancer
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 |
|---|---|---|
| QuestionnaireThe questionnaire to assess severity of LUTS in women. | Other | Female with LUTS, Normal control group |
Primary outcome
How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity.
Time frame: 10-12 months
Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) was divided into 6 subgroups of symptoms measurement, which were storage, voiding, incontinence, bladder pain, post micturition, and ability to stop voiding. The construct validity was determined by comparing the ICIQ-FLUTS LF scores of the target group with the ICIQ-FLUTS LF scores of the control group. The comparisons were performed using the Wilcoxon signed-rank test.
The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency.
Time frame: 10-12 months
The internal consistency (a parameter that verifies correlations between items within a subscale of the questionnaire) was assessed by using Cronbach's alpha coefficients. The assessment was done in each subscale of the questionnaire. If Cronbach's alpha coefficients were between 0.7 and 0.95, the instrument was considered to have good internal consistency.
The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability.
Time frame: 10-12 months
The test-retest reliability (a property of producing repeated measurements that are consistent) was verified by having the participants of the target group answer the questionnaire twice with an interval of 2 weeks between the evaluations. We calculated test-retest reliability by using weighted kappa (κ).
1 secondary outcome
The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity.
Time frame: 10-12 months
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 21 Feb 2024.
- Individual participant dataSharing planned: No
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.
Valeerat Swatesutipun, MD principal investigator
Thammasat University Hospital
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 Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire and Reliability of Thai Version of the ICIQ-FLUTS LF, run by Thammasat University Hospital at 1 site in Thailand.
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 1 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 21 Feb 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 Thailand. 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?
How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity. (time frame: 10-12 months). 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?
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 21 Feb 2024.