Etiology Study of Prostatitis

NCT01932645 | Unknown

• 1 other identifier: H13-01947
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatitis

Keywords

prostatitis; pelvic pain; urinary symptoms; sexual dysfunction

Outcome Measures

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.

  1 day

Secondary Outcomes (1)

• VB3 sample or first void after DRE for prostatitis patients vs controls

  1 day

Other Outcomes (1)

• Chronic Prostatitis Symptom Index (CPSI)

  1 day

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver General Hospital: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

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.

MeSH Terms

Conditions

Prostatitis; Pelvic Pain; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Arsovska

CONTACT

6048754111; olga.arsovska@ubc.ca

Guangming Yin

CONTACT

6048754111; yingm75@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 30, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)