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2013 Annual National Digital Rectal Exam (DRE) Day Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01886547
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : April 7, 2015
Sponsor:
Collaborators:
Philippine Board of Urology
Philippine Urology Residents Association
Information provided by (Responsible Party):
Michael E. Chua, St. Luke's Medical Center, Philippines

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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Prostatitis Prostate Cancer Other: Prostate health screening

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 925 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
New patient presented with prostate disease
prostate disease identified
Other: Prostate health screening
Other Name: Digital rectal examination, International prostate symptoms score quetionnaire




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of Prostate Diseases [ Time Frame: 1 year ]
    total number of patient consulted on Pa-DRE ka day with prostate diseases

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Filipino males ages 40 or older
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

Information from the National Library of Medicine

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


Locations
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Philippines
Philippine Urological Association Inc.
Quezon City, National Capital Region, Philippines, 1102
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
Philippine Board of Urology
Philippine Urology Residents Association

Additional Information:

Publications of Results:
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Responsible Party: Michael E. Chua, Head, Continuing Medical Education Committee of Philippine Urological Residents' Association, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT01886547    
Other Study ID Numbers: PURA-2013
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Prostatitis
Hyperplasia
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes