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

NCT06270849 | Completed

• 1 other identifier: MTU-EC-SU-0-002/66
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire; Reliability of Thai Version of the ICIQ-FLUTS LF

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  10-12 months

Study Arms (2)

Female with LUTS

Females who has symptoms of lower urinary tract symptoms

Other: Questionnaire

Normal control group

Females who no history of LUTS or urinary tract disease

Other: Questionnaire

Interventions

Questionnaire OTHER

The questionnaire to assess severity of LUTS in women.

Female with LUTS; Normal control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Valeerat Swatesutipun, MD

  Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 21, 2024
• Study Start: February 24, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 20, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)