Etiology Study of Prostatitis

Prostatitis Clinical Trial

Official title:

Modern Genetic Methods to Test EPS Samples in Prostatitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01932645
• Other study ID #: H13-01947
• Status: Recruiting
• Start date: December 2013
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Olga Arsovska
• Phone: 6048754111
• Email: olga.arsovska[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatitis

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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