Clinical trial NCT05785286: To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire
Official title: To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability of BPH 3-item questionnaire
timeFrame: up to 24 weeks
measure: Internal consistency of BPH 3-item questionnaire
timeFrame: up to 24 weeks
measure: Test-retest reliability of BPH 3-item questionnaire
timeFrame: up to 24 weeks
measure: The convergent validity of the BPH 3-item questionnaire
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.