2013 Annual National Digital Rectal Exam (DRE) Day Study
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|ClinicalTrials.gov Identifier: NCT01886547|
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment|
|Benign Prostatic Hyperplasia Prostatitis Prostate Cancer||Other: Prostate health screening|
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 :
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
- 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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||925 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||1 Year|
|Official Title:||2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
New patient presented with prostate disease
prostate disease identified
Other: Prostate health screening
Other Name: Digital rectal examination, International prostate symptoms score quetionnaire
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886547
|Philippine Urological Association Inc.|
|Quezon City, National Capital Region, Philippines, 1102|