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

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.

Study Overview

• Status: Completed
• Conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire; Reliability of Thai Version of the ICIQ-FLUTS LF
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Thailand
  • Pathumthani
    • Khlong Luang, Pathumthani, Thailand, 12120
      • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Females with lower urinary tract symptoms who can read and understand Thai language.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Female with LUTS; Females who has symptoms of lower urinary tract symptoms	Other: Questionnaire; The questionnaire to assess severity of LUTS in women.
Normal control group; Females who no history of LUTS or urinary tract disease	Other: Questionnaire; The questionnaire to assess severity of LUTS in women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	10-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-12 months

Collaborators and Investigators

• Sponsor: Thammasat University Hospital
• Investigators: Principal Investigator: Valeerat Swatesutipun, MD, Thammasat University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MTU-EC-SU-0-002/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No