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NCT Number: NCT05785286

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Alice Ho Miu Ling Nethersole Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Reliability of BPH 3-item questionnaire

    Time frame: up to 24 weeks

    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.

  2. Internal consistency of BPH 3-item questionnaire

    Time frame: up to 24 weeks

    Internal consistency was assessed by Cronbach's alpha coefficients, with >0.7 being considered acceptable

  3. Test-retest reliability of BPH 3-item questionnaire

    Time frame: up to 24 weeks

    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

  4. The convergent validity of the BPH 3-item questionnaire

    Time frame: up to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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