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

NCT05785286 | Completed

• 1 other identifier: CRE-2022.645
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

BPH 3-item questionnaire OTHER

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; Subject with male LUTS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 33879628 BACKGROUND

• 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.

  PMID: 32993275 BACKGROUND

• 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.

  PMID: 30396635 BACKGROUND

• 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.

  PMID: 19350408 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 27, 2023
• Study Start: February 27, 2023
• Primary Completion: July 31, 2024
• Study Completion: October 30, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)