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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05785286
• Other study ID #: CRE-2022.645
• Status: Active, not recruiting
• Start date: February 27, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: October 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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).

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of BPH 3-item questionnaire	Reliability was assessed by internal consistency and test-retest correlation. (?) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS.	up to 24 weeks
Primary	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
Primary	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
Primary	The convergent validity of the BPH 3-item questionnaire	was estimated by Spearman rho (?) correlation, with the IPSS (total score / voiding domain (ie Q.1, 3, 5, 6) and prostate volume measured by TRUS.	up to 24 weeks