2013 Annual National Digital Rectal Exam (DRE) Day Study

Overview

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.

Full Title of Study: “2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 2014

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.

Interventions

  • Other: Prostate health screening

Arms, Groups and Cohorts

  • New patient presented with prostate disease
    • prostate disease identified

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
    • Time Frame: 1 year
    • number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.

Secondary Measures

  • Prevalence of Prostate Diseases
    • Time Frame: 1 year
    • total number of patient consulted on Pa-DRE ka day with prostate diseases
  • International Prostate Symptom Score
    • Time Frame: 1 year
    • Total score of international Prostate Symptoms Score of each patients consulted for Prostate screening program (Pa-DRE ka day)
  • Prostate gland size estimate
    • Time Frame: 1 year
    • Estimated prostate gland size by digital rectal exam for patients presented to the prostate screening program (Pa-DRE ka day)
  • Digital rectal examination result
    • Time Frame: 1 year
    • Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Luke’s Medical Center, Philippines
  • Collaborator
    • Philippine Board of Urology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael E. Chua, Head, Continuing Medical Education Committee of Philippine Urological Residents’ Association – St. Luke’s Medical Center, Philippines

Citations Reporting on Results

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.

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