Etiology Study of Prostatitis

Modern Genetic Methods to Test EPS Samples in Prostatitis Patients

Prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. Although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. Up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. The objective of this study is to look at the etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate.

Study Overview

• Status: Recruiting
• Conditions: Prostatitis

Detailed Description

Prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. Although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. Traditional techniques to identify bacteria (e.g. on agar petri plates) are limited in what they can identify. Although HMP (Human Microbiome Project) has turned many mysteries into common sense, little is done on the relationship of bacteria in the prostate for prostatitis. Up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. The objective of this study is to look at the etiology of chronic prostatitis (bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate. Modern sequencing methods, such as 16s rRNA amplification, cloning and sequencing will be used to evaluate the role of bacteria in prostatitis. The basic idea is to survey the microbes present in expressed prostatic fluid using 16s sequencing to compare healthy men and prostatitis patients in a small cohort to see if there are correlations between microbes found and symptoms.

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Olga Arsovska; Phone Number: 62421 6048754111; Email: olga.arsovska@ubc.ca
• Study Contact Backup: Name: Guangming Yin; Phone Number: 62421 6048754111; Email: yingm75@126.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Vancouver General Hospital
      • Sub-Investigator: Ryan Paterson, MD
      • Sub-Investigator: Elspeth McDougall, MD
      • Contact: Olga Arsovska; Phone Number: 62421 6048754111
      • Sub-Investigator: Guangming Yin, MD
      • Sub-Investigator: Chris Nguan, MD
      • Sub-Investigator: Mark Nigro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with prostatitis (who are suffering from pelvic pain (perineal, suprapubic, testicular, penile etc), have urinary symptoms and sexual dysfunction (primarily pain associated with ejaculation)) vs controls

Description

Inclusion Criteria:

• chronic prostatitis (bacteria or non-bacterial prostatitis) with pelvic pain and LUTS (low urinary tract symptom); diagnosed mainly by NIH-CPSI score. We use NIH-CPSI score 15 as a base line for identifying prostatitis patients:those scored more than 15 will be grouped as prostatitis patients.

Exclusion Criteria:

• Inadequate follow-up data
• Other types of prostatits patients
• Patients who in the opinion of the investigators would not be suitable for study
• UTI patients (within 6 months before enrolment)
• Antibiotics (within 6 months before enrolment)
• Urinary tract surgery (within 6 months before enrolment)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prostatitis patients; We will enroll patients from the outpatient clinic who are suffering from pelvic pain (perineal, suprapubic, testicular, penile etc), have urinary symptoms and sexual dysfunction (primarily pain associated with ejaculation). Patients with these symptoms and identified as having prostatitis will be approached to enroll.
Controls; Male patients seen in the outpatient clinic who do not have prostatitis (not suffering from pelvic pain (perineal, suprapubic, testicular, penile etc), and do not have urinary symptoms and sexual dysfunction (primarily pain associated with ejaculation)) will be approached to enrol as controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expressed Prostatic Secretions (EPS) for bacterial species in prostatitis patients vs controls	Expressed Prostatic Secretions (EPS) will be collected post Digital Rectal Exam (DRE). These biological samples will be tested for bacterial DNA rather than the traditional microbiological culturing techniques. Identification of these bacterial DNA will then be assessed between the groups to determine if prostatitis patients, in fact, do have more bacteria than normal controls.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VB3 sample or first void after DRE for prostatitis patients vs controls	These biological samples will be tested for bacterial DNA rather than the traditional microbiological culturing techniques. Identification of these bacterial DNA will then be assessed between the groups to determine if prostatitis patients, in fact, do have more bacteria than normal controls.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Prostatitis Symptom Index (CPSI)	Validated and standardized questionnaire for this area of research will be filled out by prostatitis patients and controls.	1 day

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: sexual dysfunction; urinary symptoms; prostatitis; pelvic pain
• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis
• Other Study ID Numbers: H13-01947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No