Clinical trial NCT01886547: 2013 Annual National Digital Rectal Exam (DRE) Day Study
Official title: 2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Prostatitis
Prostate Cancer
Lead sponsor: St. Luke's Medical Center, Philippines
Sponsor class: OTHER
Collaborators: name: Philippine Board of Urology
name: Philippine Urology Residents Association
First posted: 2013-06-26
Enrollment: 925
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino males ages 40 or older

Brief summary: We aim to determine the effectiveness of 2013 "Mag paDRE ka" programme in increasing general public awareness on prostate health and promoting prostate health assessment among Filipino males aged 40 or older.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Filipino male ages 40 or older consulted on "Pa-DRE ka" prostate health screening program 2013
* patients presented to the Philippine Board of Urology accredited 11 training institutions
* Consented for the screening program.
* Completed the questionnaire of International Prostate symptoms score
* Has been examined with digital rectal examination

Exclusion Criteria:

* Patients who have incomplete data and did not consent for the screening program
* Non-Filipino male patients

Primary outcomes:
measure: Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of Prostate Diseases
timeFrame: 1 year
measure: International Prostate Symptom Score
timeFrame: 1 year
measure: Prostate gland size estimate
timeFrame: 1 year
measure: Digital rectal examination result
timeFrame: 1 year
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Philippine Urological Association Inc.
state: National Capital Region
Study officials:
References:
citation: Chua ME, Lapitan MC, Morales ML Jr, Roque AB, Domingo JK; Philippine Urological Residents Association (PURA). 2013 Annual National Digital Rectal Exam Day: impact on prostate health awareness and disease detection. Prostate Int. 2014 Mar;2(1):31-6. doi: 10.12954/PI.13039. Epub 2014 Mar 30.