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临床试验/NCT01886547
NCT01886547已完成不适用

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

St. Luke's Medical Center, Philippines1 个研究点 分布在 1 个国家目标入组 925 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
925
试验地点
1
主要终点
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who have incomplete data and did not consent for the screening program
  • Non-Filipino male patients

结局指标

主要结局

Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)

时间窗: 1 year

number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.

次要结局

  • Prevalence of Prostate Diseases(1 year)
  • Digital rectal examination result(1 year)
  • Prostate gland size estimate(1 year)
  • International Prostate Symptom Score(1 year)

研究者

发起方
St. Luke's Medical Center, Philippines
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael E. Chua

Head, Continuing Medical Education Committee of Philippine Urological Residents' Association

St. Luke's Medical Center, Philippines

研究点 (1)

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