Microbiome of Urologic Chronic Pelvic Pain Syndrome

Withdrawn

• Conditions: Chronic Prostatitis; Prostatitis; Interstitial Cystitis; Bladder Pain Syndrome; Painful Bladder Syndrome
• Interventions: Procedure: Collect midstream urine samples; Procedure: Genitourinary Specimen Collection

• Registration Number: NCT03027076
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Control group exclusion criteria:

In addition to the exclusion criteria listed above, additional criteria for control subjects are as follows:

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic Women	Collect midstream urine samples	Collect midstream urine samples
Men with UCPPS	Genitourinary Specimen Collection	Genitourinary Specimen Collection for microbiome evaluation
Women with UCPPS	Collect midstream urine samples	Collect midstream urine samples
Asymptomatic Men	Genitourinary Specimen Collection	Genitourinary Specimen Collection for microbiome evaluation

Primary Outcome Measures

Name	Time	Method
Microbiome	Within 6 month period from baseline evaluation	Evaluate the microbiome at baseline, one "good day" (minimal or no symptoms) and one "bad day" (worst symptoms) within a 6 month period

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States