Benign Prostatic HyperplasiaNCT01886547
2013 Annual National Digital Rectal Exam (DRE) Day Study
An observational study of Benign Prostatic Hyperplasia and Prostatitis, run by St. Luke's Medical Center, Philippines at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia, Prostatitis, Prostate Cancer
- What is being tested?
- Prostate health screening
- How many people
- 925 participants
- Where
- 1 sitePhilippines
- Study dates
- Jun 2013to Oct 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Filipino males ages 40 or older
Who may be able to join
- 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
Who cannot join
- Patients who have incomplete data and did not consent for the screening program
- Non-Filipino male patients
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine Urological Association Inc.
Quezon City, National Capital Region, 1102
About this study
Official title: 2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection
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.
Read the 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 :
- 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.
- Conditions
- Benign Prostatic Hyperplasia, Prostatitis, Prostate Cancer
- Being tested
- Prostate health screening
- Medical subject headings
- Prostatic Hyperplasia, Prostatitis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate health screeningOther
Also called Digital rectal examination, International prostate symptoms score quetionnaire
| Study group | Role | What they receive |
|---|---|---|
| New patient presented with prostate disease | prostate disease identified Receives: Other: Prostate health screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Prevalence of Prostate Diseases
total number of patient consulted on Pa-DRE ka day with prostate diseases
Measured: 1 year
International Prostate Symptom Score
Total score of international Prostate Symptoms Score of each patients consulted for Prostate screening program (Pa-DRE ka day)
Measured: 1 year
Prostate gland size estimate
Estimated prostate gland size by digital rectal exam for patients presented to the prostate screening program (Pa-DRE ka day)
Measured: 1 year
Digital rectal examination result
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 925 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center, Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Philippine Board of Urology, Philippine Urology Residents Association
- Responsible party
- Principal investigator, Michael E. Chua, St. Luke's Medical Center, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886547
- Sponsor's protocol ID
- PURA-2013
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24693532
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection
- ClinicalTrials.gov ID
- NCT01886547
- Acronym / sponsor ID
- PURA-2013
- Conditions
- Benign Prostatic Hyperplasia, Prostatitis, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 925 participants (actual)
- Lead sponsor
- St. Luke's Medical Center, PhilippinesUniversity, hospital or other
- Collaborators
- Philippine Board of Urology, Philippine Urology Residents Association
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New patient presented with prostate disease | – | Other: Prostate health screeningprostate disease identified |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Filipino males ages 40 or older
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have incomplete data and did not consent for the screening program
- Non-Filipino male patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate health screeningAlso: Digital rectal examination, International prostate symptoms score quetionnaire | Other | New patient presented with prostate disease |
Primary outcome
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.
4 secondary outcomes
Prevalence of Prostate Diseases
Time frame: 1 year
International Prostate Symptom Score
Time frame: 1 year
Prostate gland size estimate
Time frame: 1 year
Digital rectal examination result
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 24693532Chua 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Prostatitis, run by St. Luke's Medical Center, Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.