Dataset from Implementation of a Screening Tool for Subjects With Benign Prostatic Enlargement/Obstruction to Identify Men >=50 Years Presenting in General Practice With Other Co-morbidities Who Should be Assessed for BPH

This non-randomized, interventional study will be conducted in a general practice setting to
assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO)
screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed
to have BPH on full urologist assessment of diagnostic test results. The tool may help a
General Practitioners (GP) to identify subjects who may have BPH for further tests and
improve the speed of referrals to specialists when this is appropriate. The utility of the
screening tool will be compared to the validated tool in wide clinical use, the International
Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the
primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary
tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of
this screening tool will be used for further investigation. All subjects testing positive on
the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and
offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1).
The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist
to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP
will make a diagnosis of probable BPH based upon screening results and lab tests which
suggest that they are related to BPH and not other causes of such symptoms. The GP will phone
the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has
probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject
does not have probable BPH, then it will be considered that the subject has completed the
study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment
performed by an urologist. This assessment includes a DRE and a brief physical exam and
review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of
progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to
this study will be screened for probable BPH to yield 500 subjects being referred to an
urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow
for GP and urologist visit scheduling.