Clinical trial NCT01932645: Etiology Study of Prostatitis
Official title: Modern Genetic Methods to Test EPS Samples in Prostatitis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatitis
Keywords: prostatitis
pelvic pain
urinary symptoms
sexual dysfunction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver General Hospital
First posted: 2013-08-30
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Expressed Prostatic Secretions (EPS) for bacterial species in prostatitis patients vs controls
timeFrame: 1 day
Secondary outcomes:
measure: VB3 sample or first void after DRE for prostatitis patients vs controls
timeFrame: 1 day
Other outcomes:
measure: Chronic Prostatitis Symptom Index (CPSI)
timeFrame: 1 day
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: