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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-27

Study Completion Date

2024-10-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia (BPH)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

BPH 3-item questionnaire

Intervention Type 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

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.

BPH 3-item questionnaire

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No