ClinicalTrials.gg
Status unknownNCT01932645Updated May 17, 2022

Etiology Study of Prostatitis

An observational study in Prostatitis, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by University of British Columbia · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
24
Ages
19 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostatitis

Keywords

  • prostatitis
  • pelvic pain
  • urinary symptoms
  • sexual dysfunction
03

In context

Prostatitis

87 studies on the registry are indexed under Prostatitis; 9 are open to participants now.

This study's planned enrollment of 24 is below the median of 224 across 16 observational studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,335 studies on the registry; 255 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

Other outcomes

  1. Chronic Prostatitis Symptom Index (CPSI)

    Validated and standardized questionnaire for this area of research will be filled out by prostatitis patients and controls.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Vancouver General Hospital
    Vancouver, British Columbia V5Z1M9, Canada
    • Olga Arsovska · Contact · 6048754111
    • Guangming Yin, MD · Sub investigator
    • Ryan Paterson, MD · Sub investigator
    • Elspeth McDougall, MD · Sub investigator
    • Chris Nguan, MD · Sub investigator
    • Mark Nigro, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Dec 2023 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2013
First posted
Aug 30, 2013
Start
Dec 2013
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
May 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01932645
Collaborators
Vancouver General Hospital
Responsible party
Ben Chew, MD (Associate Professor, University of British Columbia) — Principal investigator
First posted
Aug 30, 2013
Start date
Dec 2013
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
May 17, 2022

Study contacts

Olga Arsovska
Contact
olga.arsovska@ubc.ca
6048754111 ext. 62421
Guangming Yin
Contact
yingm75@126.com
6048754111 ext. 62421
Ben Chew, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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