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Completed

NCT Number: NCT06270849

Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With 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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age at or over 18 years old
  • can read and understand Thai language
  • have lower urinary tract symptoms

Exclusion criteria

  • those who have a diagnosis of calculi, urinary tract cancer

Treatment and study plan

Questionnaire

Other

The questionnaire to assess severity of LUTS in women.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity.

    Time frame: 10-12 months

    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.

Sponsors and collaborators

Lead sponsor

Thammasat University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.