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ORIGINAL ARTICLE   Free accessfree

Minerva Urology and Nephrology 2022 February;74(1):85-92

DOI: 10.23736/S2724-6051.20.03834-5


language: English

Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort

Andrea TUBARO 1, Mauro NIERO 2, Burkay ADALIG 3, Zrinka LULIC 4 , Janet PLASTINO 5, Carie KIMBROUGH 6, Michael J. MANYAK 7

1 Department of Clinical and Molecular Medicine, Faculty of Health Sciences, Sapienza University, Rome, Italy; 2 Department of Human Sciences, University of Verona, Verona, Italy; 3 Classic and Established Products, Urology, GlaxoSmithKline (GSK), Istanbul, Turkey; 4 Classic and Established Products, Urology, GlaxoSmithKline (GSK), Brentford, UK; 5 RD Projects Clinical Platforms and Sciences, GlaxoSmithKline (GSK), Collegeville, PA, USA; 6 Department of Biostatistics, PAREXEL International, Durham, NC, USA; 7 Classic and Established Products, Global Medical Urology, GlaxoSmithKline (GSK), Washington DC, WA, USA

BACKGROUND: Benign prostatic hyperplasia (BPH), a progressive condition and common cause of lower urinary tract symptoms (LUTS), is underdiagnosed in primary care, impacting patient outcomes. Here, we evaluate the utility of a BPH screening tool in general practice, to identify men confirmed to have BPH after urologist assessment of diagnostic test results.
METHODS: A 3-item questionnaire was developed to discriminate between LUTS due to BPH versus other conditions and was translated and validated cross-culturally. Its utility was assessed in a cohort study (FDC116114/NCT02757963) conducted in 47 centers across France, Germany, Italy, Russia, and Spain. The study enrolled men ≥50 years of age presenting to general practice clinics with a score of ≥3 on the BPH screening tool or ≥8 on the International Prostate Symptom Score (IPSS). In total, 561 men completed the study. The primary endpoint was the proportion of patients with a urologist-confirmed BPH diagnosis among those with a positive result on the BPH screening tool (score ≥3) and serum prostate specific antigen (PSA) ≥2 ng/mL.
RESULTS: The primary endpoint was fulfilled; 88.3% (95% CI: 84.9, 91.2) of patients had urologist-confirmed BPH diagnoses among those with positive results on the BPH screening tool and serum PSA≥2 ng/mL, similar to the proportion seen with IPSS≥8 and serum PSA≥2 ng/mL (87.7%; 95% CI: 84.6, 90.4).
CONCLUSIONS: The BPH screening tool, in conjunction with serum PSA, demonstrated adequate predictive value by allowing general practitioners to quickly screen men presenting with different medical conditions but identified as having urological symptoms.

KEY WORDS: Urology; Primary health care; Prostatic diseases; Male urogenital diseases

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