Trial Information

2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection

Convenience sampling method will be applied to collect all completed Philippine Urological
Association (PUA) survey forms from the 11 Philippine Board of Urology accredited training
institutions. A data collection form for the purpose of this study will be used to extract
data from the Philippine Urological Association survey forms. The data collection form for
this study will extract data, which include basic demographic characteristics of the
patients (such as age and educational attainment), family history of prostate cancer, other
medical conditions, history of prior prostate screening/ consultation for Lower urinary
tract Symptoms or prostate disease. The International Prostate Symptom scores (IPSS)
collected will be stratified according to mild (1-7), moderate (8-19) and severe (20-35) and
the Filipino version Quality of Life (QoL) ratings will be stratified according to Grade 1,
grade 2 and grade 3. DRE findings including the approximation of prostate size and prostate
characteristic findings will be clustered to normal in size (20grams or less) versus
enlarged (>20grams or 2 fingerbreadths in width), nodular vs non-nodular, doughy or hard,
and tender versus non-tender.

Participants will be classified according to the following :

1. Target population for screening or not :

Target population for screening is defined as Filipino males aged 40 years or older,
who also had no previous consultation for Lower urinary tract symptoms (LUTS) or
prostate cancer screening in the past 12 months

2. Case Finding for significant LUTS or prostate cancer or not :

Case of LUTS or prostate cancer is defined as Filipino males aged 40 years or older with
IPSS > 8, OR, has abnormal Digital rectal exam (DRE) finding, which is defined as nodular OR
hard OR tender. However, DRE finding of an enlarged prostate but non-nodular, doughy in
character and non-tender will not be considered as a case of LUTS or prostate cancer
suspect).

Confidentiality of all data will be assured. The case report forms/ data collection form for
this study will not contain any patient identifiers. All patient records will be coded in
the electronic database as serial number and PUA-designated Institutional code (i.e. SLMC
#0001). Only the investigators of this study and other authorized personnel from PUA will be
given access to the study data. The PUA survey forms will be secured, filed and only
accessed in PUA secretariat building. The electronic database coded with the data from the
data collection from of this study will be set with password, and only the study
investigators have access to the password.