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Trial record 1 of 1 for:    NCT01932645
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Etiology Study of Prostatitis

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ClinicalTrials.gov Identifier: NCT01932645
Recruitment Status : Recruiting
First Posted : August 30, 2013
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Vancouver General Hospital
Information provided by (Responsible Party):
Ben Chew, MD, University of British Columbia

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Modern Genetic Methods to Test EPS Samples in Prostatitis Patients
Study Start Date : December 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.



Primary Outcome Measures :
  1. Expressed Prostatic Secretions (EPS) for bacterial species in prostatitis patients vs controls [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. VB3 sample or first void after DRE for prostatitis patients vs controls [ Time Frame: 1 day ]
    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.


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


Biospecimen Retention:   Samples With DNA

Patients will have a digital rectal exam (DRE) performed and have their Expressed Prostatic Secretions (EPS) sampled as well as the first void after the DRE (other wise called the VB3 sample). Patients will also have their maximum urinary flow rate tested by voiding into a special machine. This will be done at the urology clinic, 6th floor Diamond Building.

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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932645


Contacts
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Contact: Olga Arsovska 6048754111 ext 62421 olga.arsovska@ubc.ca
Contact: Guangming Yin 6048754111 ext 62421 yingm75@126.com

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Olga Arsovska    6048754111 ext 62421      
Sub-Investigator: Guangming Yin, MD         
Sub-Investigator: Ryan Paterson, MD         
Sub-Investigator: Elspeth McDougall, MD         
Sub-Investigator: Chris Nguan, MD         
Sub-Investigator: Mark Nigro, MD         
Sponsors and Collaborators
University of British Columbia
Vancouver General Hospital
Investigators
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Principal Investigator: Ben Chew, MD University of British Columbia
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Responsible Party: Ben Chew, MD, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01932645    
Other Study ID Numbers: H13-01947
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ben Chew, MD, University of British Columbia:
prostatitis
pelvic pain
urinary symptoms
sexual dysfunction
Additional relevant MeSH terms:
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Prostatitis
Prostatic Diseases
Genital Diseases, Male