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

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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Other: BPH 3-item questionnaire

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital
  • Sha Tin, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 at the time of enrolment. Or male-LUTS subject who is waiting for their transurethral ablative prostate surgery for their symptomatic BPE.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subject with male LUTS; 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; 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).
Subject who is waiting for their transurethral ablative prostate surgery; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nephrol. 2022 Feb;74(1):85-92. doi: 10.23736/S2724-6051.20.03834-5. Epub 2020 Sep 29.
• Chiu PK, Ng CF, Semjonow A, Zhu Y, Vincendeau S, Houlgatte A, Lazzeri M, Guazzoni G, Stephan C, Haese A, Bruijne I, Teoh JY, Leung CH, Casale P, Chiang CH, Tan LG, Chiong E, Huang CY, Wu HC, Nieboer D, Ye DW, Bangma CH, Roobol MJ. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol. 2019 Apr;75(4):558-561. doi: 10.1016/j.eururo.2018.10.047. Epub 2018 Nov 2.
• Chu PSK, Leung CLH, Cheung MH, Woo SWS, Lo TK, Chan TNH, Wong WKK. Hong Kong Geriatrics Society and Hong Kong Urological Association consensus on personalised management of male lower urinary tract symptoms in the era of multiple co-morbidities and polypharmacy. Hong Kong Med J. 2021 Apr;27(2):127-139. doi: 10.12809/hkmj209049.
• Stravodimos KG, Petrolekas A, Kapetanakis T, Vourekas S, Koritsiadis G, Adamakis I, Mitropoulos D, Constantinides C. TRUS versus transabdominal ultrasound as a predictor of enucleated adenoma weight in patients with BPH: a tool for standard preoperative work-up? Int Urol Nephrol. 2009 Dec;41(4):767-71. doi: 10.1007/s11255-009-9554-9. Epub 2009 Apr 7.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CRE-2022.645

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