An observational study in Psychometric Validation of Men's Health Questionnaires, sponsored by Andijan State Medical Institute. Recruiting at 1 site in Uzbekistan. Open to male participants aged 35 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Andijan State Medical Institute · Observational
This observational study aims to evaluate the reliability and validity of the Uzbek-language versions of three questionnaires used to assess men's health: the Androgen Deficiency in Aging Males (ADAM), Aging Males' Symptoms (AMS), and International Prostate Symptom Score (IPSS).
The study will include approximately 400 men aged 35-59 years from the Andijan region of Uzbekistan. Participants will complete all three questionnaires electronically using Google Forms. At least 120 participants will complete the questionnaires again after 7-14 days to assess the consistency of their responses.
Blood samples will be collected to measure total testosterone levels and examine their relationship with questionnaire results. The study will also assess how well ADAM identifies men with low testosterone levels and how reliably AMS and IPSS measure their respective symptoms.
No treatment or experimental intervention will be administered. The findings will help determine whether these Uzbek-language questionnaires are suitable for use in clinical practice and future research.
TESMEN-VALID is an observational methodological study designed to assess the psychometric properties of the Uzbek-language versions of ADAM, AMS, and IPSS among men aged 35-59 years in Uzbekistan.
The questionnaires previously underwent forward and backward translation, expert review, and cultural adaptation. Initial pilot testing involved 51 Uzbek-speaking men, followed by preliminary psychometric assessment in 105 men. These preliminary participants will not be included in the main TESMEN-VALID analytical sample.
Approximately 400 men will be recruited through community announcements, primary healthcare facilities, and urological services in the Andijan region. At least 350 complete questionnaire sets are expected. All questionnaires will be self-administered electronically using standardized Uzbek-language versions, regardless of the participant's location.
The study will assess the following measurement properties:
At least 120 clinically stable participants will complete a second assessment after 7-14 days. Serum total testosterone will be measured in morning fasting venous blood samples using a chemiluminescent microparticle immunoassay.
Confirmatory factor analysis will be performed for AMS and IPSS. Reliability will be evaluated using intraclass correlation coefficients and agreement statistics, as appropriate. Construct validity will be assessed through predefined associations with relevant clinical and laboratory measures. Screening sensitivity and specificity of ADAM will be evaluated against biochemically low total testosterone, not a confirmed clinical diagnosis of hypogonadism.
Recruitment will include men with varying severity of lower urinary tract symptoms to support psychometric evaluation of IPSS across a broader symptom range.
The study will follow COSMIN methodological principles. Statistical analyses will be performed using IBM SPSS Statistics and R.
Andijan State Medical Institute is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of Uzbek-speaking men aged 35-59 years residing in the Andijan region of Uzbekistan. Approximately 400 participants will be recruited through community announcements, primary healthcare facilities, and urological services. Men with and without androgen-related or lower urinary tract symptoms will be eligible. Recruitment will include participants with varying symptom severity to support psychometric evaluation of the questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Chronic diseases, lower urinary tract symptoms, and previously diagnosed hypogonadism will not automatically constitute exclusion criteria. Relevant diagnoses, medications, and concomitant conditions will be recorded for analysis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 400 Uzbek-speaking men aged 35-59 years will be recruited in the Andijan region of Uzbekistan. All participants will complete the Uzbek-language versions of the ADAM, AMS, and IPSS questionnaires electronically. Serum total testosterone will be measured. At least 120 clinically stable participants will repeat the questionnaires after 7-14 days to assess test-retest reliability. Participants from the preliminary validation study will not be included.
Structural Validity of the Uzbek-Language AMS Questionnaire
The structural validity of the 17-item Uzbek-language Aging Males' Symptoms (AMS) questionnaire will be evaluated using confirmatory factor analysis (CFA) with weighted least squares mean and variance adjusted (WLSMV) estimation. The prespecified three-factor model comprises psychological, somatic, and sexual symptom domains. Each item is scored from 1 to 5, yielding a total score ranging from 17 to 85, with higher scores indicating greater symptom severity. Structural validity will be assessed using standardized factor loadings and model fit indices: comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR).
Time frame: Baseline assessment (Day 1)
Structural Validity of the Uzbek-Language IPSS Questionnaire
The structural validity of the Uzbek-language International Prostate Symptom Score (IPSS) questionnaire will be evaluated using confirmatory factor analysis (CFA) with weighted least squares mean and variance adjusted (WLSMV) estimation. The seven symptom items will be examined using prespecified one-factor and two-factor models, with the latter distinguishing voiding and storage symptoms. Each symptom item is scored from 0 to 5, yielding a total score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The additional quality-of-life item is scored separately from 0 to 6 and will not be included in the factor analysis. Structural validity will be assessed using standardized factor loadings and model fit indices: comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR).
Time frame: Baseline assessment (Day 1)
Test-Retest Agreement of the Uzbek-Language ADAM Questionnaire
The test-retest agreement of the Uzbek-language Androgen Deficiency in Aging Males (ADAM) questionnaire will be assessed among clinically stable participants. ADAM consists of 10 items with yes/no responses and produces an overall positive or negative screening classification according to the standard scoring algorithm. A positive screening result indicates the presence of symptoms suggestive of androgen deficiency, but does not establish a clinical diagnosis of hypogonadism. Agreement between baseline and repeat screening classifications will be evaluated using Cohen's kappa coefficient with a 95% confidence interval. Higher kappa values indicate greater agreement beyond chance.
Time frame: Baseline (Day 1) and repeat assessment (Days 7-14)
Test-Retest Reliability of the Uzbek-Language AMS Total Score
Test-retest reliability of the Uzbek-language Aging Males' Symptoms (AMS) questionnaire total score will be assessed among clinically stable participants using the intraclass correlation coefficient (ICC) with a 95% confidence interval. The AMS consists of 17 items scored from 1 to 5, yielding a total score ranging from 17 to 85, with higher scores indicating greater symptom severity. Reliability will be estimated from paired total scores obtained at baseline and repeat assessment.
Time frame: Baseline (Day 1) and repeat assessment (Days 7-14)
Test-Retest Reliability of the Uzbek-Language IPSS Total Score
Test-retest reliability of the Uzbek-language International Prostate Symptom Score (IPSS) questionnaire total symptom score will be assessed among clinically stable participants using the intraclass correlation coefficient (ICC) with a 95% confidence interval. The IPSS total symptom score is calculated from seven items scored from 0 to 5, yielding a total score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The separate quality-of-life item is not included in the total symptom score. Reliability will be estimated from paired total scores obtained at baseline and repeat assessment.
Time frame: Baseline (Day 1) and repeat assessment (Days 7-14)
Internal Consistency of the Uzbek-Language AMS Questionnaire
Internal consistency of the Uzbek-language Aging Males' Symptoms (AMS) questionnaire will be evaluated using Cronbach's alpha after evaluation of the dimensional structure. Internal consistency will be reported for each unidimensional scale or subscale supported by the confirmatory factor analysis. The AMS consists of 17 items scored from 1 to 5 and has a total score ranging from 17 to 85, with higher scores indicating greater symptom severity.
Time frame: Baseline assessment (Day 1)
Internal Consistency of the Uzbek-Language IPSS Questionnaire
Internal consistency of the Uzbek-language International Prostate Symptom Score (IPSS) questionnaire will be evaluated using Cronbach's alpha after evaluation of the dimensional structure. Internal consistency will be reported for each unidimensional scale or subscale supported by the confirmatory factor analysis. The seven symptom items are scored from 0 to 5, yielding a total symptom score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The separate quality-of-life item will not be included in the internal consistency analysis of the symptom scale.
Time frame: Baseline assessment (Day 1)
Measurement Error of the Uzbek-Language AMS Total Score
Measurement error of the Uzbek-language Aging Males' Symptoms (AMS) questionnaire will be evaluated among clinically stable participants using the standard error of measurement (SEM) and smallest detectable change at the 95% confidence level (SDC95), based on paired baseline and retest total scores. The AMS consists of 17 items scored from 1 to 5, yielding a total score ranging from 17 to 85, with higher scores indicating greater symptom severity. SEM and SDC95 will be expressed in AMS total-score points.
Time frame: Baseline (Day 1) and repeat assessment (Days 7-14)
Measurement Error of the Uzbek-Language IPSS Total Score
Measurement error of the Uzbek-language International Prostate Symptom Score (IPSS) questionnaire will be evaluated among clinically stable participants using the standard error of measurement (SEM) and smallest detectable change at the 95% confidence level (SDC95), based on paired baseline and retest total symptom scores. The seven symptom items yield a total score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The separate quality-of-life item is not included in the total symptom score. SEM and SDC95 will be expressed in IPSS total-score points.
Time frame: Baseline (Day 1) and repeat assessment (Days 7-14)
Construct Validity of ADAM, AMS, and IPSS
Construct validity of the Uzbek-language Androgen Deficiency in Aging Males (ADAM), Aging Males' Symptoms (AMS), and International Prostate Symptom Score (IPSS) questionnaires will be evaluated by testing prespecified hypotheses concerning the direction and magnitude of associations with relevant external measures and/or differences between clinically defined groups. ADAM will be analyzed using its binary positive or negative screening classification; AMS will be analyzed using its total score and prespecified domain scores where applicable; and IPSS will be analyzed using its seven-item total symptom score. Observed associations or group differences will be compared with the prespecified hypotheses. Diagnostic performance of ADAM against biochemically low testosterone will be evaluated separately.
Time frame: Baseline assessment (Day 1)
Sensitivity and Specificity of ADAM for Biochemically Low Testosterone
The diagnostic performance of the Uzbek-language Androgen Deficiency in Aging Males (ADAM) questionnaire for identifying biochemically low serum total testosterone will be evaluated using sensitivity and specificity with 95% confidence intervals. ADAM consists of 10 yes/no items and is classified as positive when the participant answers yes to item 1 or item 7, or to any three of the remaining items. Biochemically low serum total testosterone will be defined as a baseline serum total testosterone concentration \<12.0 nmol/L (approximately \<346 ng/dL), measured in a fasting morning venous blood sample using the study laboratory's validated assay. This biochemical classification will be used as the reference standard for calculating sensitivity and specificity and does not, by itself, constitute a clinical diagnosis of hypogonadism.
Time frame: Baseline assessment (Day 1)
Floor and Ceiling Effects of the Uzbek-Language AMS Total Score
Floor and ceiling effects of the Uzbek-language Aging Males' Symptoms (AMS) questionnaire total score will be evaluated at baseline. The AMS total score ranges from 17 to 85, with higher scores indicating greater symptom severity. Floor and ceiling effects will be summarized as the percentage of participants obtaining the minimum possible total score of 17 and the maximum possible total score of 85, respectively.
Time frame: Baseline assessment (Day 1)
Floor and Ceiling Effects of the Uzbek-Language IPSS Total Score
Floor and ceiling effects of the Uzbek-language International Prostate Symptom Score (IPSS) total symptom score will be evaluated at baseline. The seven-item IPSS total symptom score ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. Floor and ceiling effects will be summarized as the percentage of participants obtaining the minimum possible total score of 0 and the maximum possible total score of 35, respectively. The separate quality-of-life item is not included in this analysis.
Time frame: Baseline assessment (Day 1)
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Andijan State Medical Institute