Microbiome of Urologic Chronic Pelvic Pain Syndrome

NCT ID: NCT03027076

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-01-31

Brief Summary

This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).

Detailed Description

This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).

A microbiome is defined as "the ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space." (Lederberg, 2001) The present study is designed to establish the prostate, urinary bladder and urethral microbiome in men with chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral microbiome in women with interstitial cystitis/painful bladder syndrome.

The human urethra, bladder and prostate normally harbor microbial communities. The recent advent of large-scale "omics" technologies allows a detailed analysis of those communities. While current knowledge of the normal inhabitants of the human urogenital tract remains incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a "urinary tract infection". The causative agents in most of those cases remain unknown, partly due to the limitations of older detection technologies that require the detection and isolation of a single microorganism for implicating it as a causative agent. Furthermore, many microbial species remain unculturable and therefore, are often undetectable using standard technology.

The current project will utilize state-of-the-art "omic" technology to detect and identify microbial species in the urethra and bladder of both men and women and the prostate of men. Additionally, the inflammatory response that accompanies those microbial communities will be characterized. Finally, the presence and number of microbial species will be correlated with the intensity of the inflammatory response and the severity of symptoms that patients with UCPPS experience.

Conditions

Prostatitis; Chronic Prostatitis; Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Men with UCPPS

Genitourinary Specimen Collection for microbiome evaluation

Genitourinary Specimen Collection

Intervention Type: PROCEDURE

Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)

Asymptomatic Men

Genitourinary Specimen Collection for microbiome evaluation

Genitourinary Specimen Collection

Intervention Type: PROCEDURE

Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)

Women with UCPPS

Collect midstream urine samples

Collect midstream urine samples

Intervention Type: PROCEDURE

Collect midstream urine samples

Asymptomatic Women

Collect midstream urine samples

Collect midstream urine samples

Intervention Type: PROCEDURE

Collect midstream urine samples

Interventions

Genitourinary Specimen Collection

Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)

Intervention Type: PROCEDURE

Collect midstream urine samples

Collect midstream urine samples

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board;
• Agreement: Participant agrees to participate in study procedures;
• Age: Participant is at least 18 years of age;
• Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire;
• Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months.

Exclusion Criteria

• Urethral conditions: Participant has an ongoing symptomatic urethral stricture;
• Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy;
• Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms;
• Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure;
• Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome);
• Psychiatric conditions: Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.);
• Malignancy: Participant has a history of cancer (with the exception of skin cancer).

• Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region for a period longer than 3 months within the preceding year;
• Infection: Volunteers who have had a urinary tract infection with a urine culture value of >100,000 colony forming units/ml (CFU/ml) within the past three months.
• Intravesical Therapy: Volunteers treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) therapy;
• Gastrointestinal Conditions: Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur L Burnett, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00089692

Identifier Type: -

Identifier Source: org_study_id