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Completed

NCT Number: NCT01886547

2013 Annual National Digital Rectal Exam (DRE) Day Study

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.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Philippine Urological Association Inc.

Quezon City, National Capital Region, 1102, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate health screening

Other

Other names: Digital rectal examination, International prostate symptoms score quetionnaire

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

St. Luke's Medical Center, Philippines

Other

Collaborators

  • Philippine Board of Urology
  • Philippine Urology Residents Association

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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