2013 Annual National Digital Rectal Exam (DRE) Day Study

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886547
• Other study ID #: PURA-2013
• Status: Completed
• Phase: N/A
• First received: June 23, 2013
• Last updated: April 5, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: St. Luke's Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of HealthPhilippines: Ethics CommitteePhilippines: Philippine Council for Health Research and Development
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 925
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostate Cancer
• Prostatic Hyperplasia
• Prostatitis

Intervention

Other:
• Prostate health screening

Locations

Country	Name	City	State
Philippines	Philippine Urological Association Inc.	Quezon City	National Capital Region

Sponsors (3)

Lead Sponsor	Collaborator
St. Luke's Medical Center, Philippines	Philippine Board of Urology, Philippine Urology Residents Association

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)	number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.	1 year	No
Secondary	Prevalence of Prostate Diseases	total number of patient consulted on Pa-DRE ka day with prostate diseases	1 year	No
Secondary	International Prostate Symptom Score	Total score of international Prostate Symptoms Score of each patients consulted for Prostate screening program (Pa-DRE ka day)	1 year	No
Secondary	Prostate gland size estimate	Estimated prostate gland size by digital rectal exam for patients presented to the prostate screening program (Pa-DRE ka day)	1 year	No
Secondary	Digital rectal examination result	Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)	1 year	No