To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire

Study Overview
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Brief Summary
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This study is to linguistically and psychometrically validate the translated and culturally adapted Hong Kong Chinese version of the BPH 3-item questionnaire.

Detailed Description
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A new BPH 3-item questionnaire has recently been developed and published, and it may serve as a screening tool for male-LUTS due to symptomatic BPE. The questionnaire consists of only three items. A raw score ranging from 0 to 5 is assigned to each of the items, giving a final total score varying from 0 (no symptom) to 15 (very symptomatic). This questionnaire has been translated and validated into five different European languages and was harmonized cross-culturally for linguistic validation, followed by psychometric accuracy testing. This new questionnaire may help rationalize more early commencement of therapy aimed at reducing the prostate size for the treatment of male LUTS due to BPE.

Official Title
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To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire.

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Other: BPH 3-item questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 90 years old Chinese male subjects presented with male-LUTS for at least 4 weeks The subjects are able to read and fully comprehend with the content of the questionnaires The subjects are willing to give informed consent for the study Exclusion Criteria: peak uroflow ≤4mL/sec; post-void residual (PVR) ≥300 mL; unable to give informed consent need of clean intermittent self-catheterization / indwelling urethral catheterization at the time of enrolment; Surgical treatment (e.g. TURP) of bladder outlet obstruction / symptomatic benign prostate enlargement (BPE) ≤ 3 months before entry into the study clinical suspicion / presence of untreated urethral stricture and/or bladder neck stenosis, clinical suspicion / presence of genitourinary cancer including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria; uncontrolled heart failure / diabetes mellitus(DM) / hypertension(HT); neuropathic bladder; Currently on dialysis or in consideration for dialysis due to end stage renal disease; More than 3 urinary tract infections within the last 12 months; Unstable dose of diuretic within the past 3 months; Has an artificial urinary sphincter; Impaired mental status; male-LUTS due to urinary tract infections / chronic prostatitis / chronic pelvic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject with male LUTS<br>Male subjects who have been bothered by male LUTS for at least 4 weeks and are still able to pass urine on their own without the need of assistance or urethral catheterization. | Other: BPH 3-item questionnaire<br>* BPH 3-item questionnaire. The questionnaire consists of only three items. A raw score ranging from 0 to 5 is assigned to each of the items, giving a final total score varying from 0 (no symptom) to 15 (very symptomatic).<br>|
| Subject who is waiting for their transurethral ablative prostate surgery<br>Male subjects who are waiting for BPH surgery and are still able to pass urine on their own without the need of assistance or urethral catheterization. | Other: BPH 3-item questionnaire<br>* BPH 3-item questionnaire. The questionnaire consists of only three items. A raw score ranging from 0 to 5 is assigned to each of the items, giving a final total score varying from 0 (no symptom) to 15 (very symptomatic).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of BPH 3-item questionnaire | Reliability was assessed by internal consistency and test-retest correlation. (ρ) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS. | up to 24 weeks | 
| Internal consistency of BPH 3-item questionnaire | Internal consistency was assessed by Cronbach's alpha coefficients, with >0.7 being considered acceptable | up to 24 weeks | 
| Test-retest reliability of BPH 3-item questionnaire | Test-retest reliability was assessed by intra-class correlation coefficient. Values between 0.6 and 0.8 indicate substantial agreement, and values over 0.8 indicate near-perfect agreement | up to 24 weeks | 
| The convergent validity of the BPH 3-item questionnaire | was estimated by Spearman rho (ρ) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS. | up to 24 weeks |