Microbiome of Urologic Chronic Pelvic Pain Syndrome

Interstitial Cystitis Clinical Trial

Official title:

Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03027076
• Other study ID #: NA_00089692
• Status: Withdrawn
• Phase: N/A
• First received: January 18, 2017
• Last updated: August 28, 2017
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Chronic Disease
• Chronic Prostatitis
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Painful Bladder Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Genitourinary Specimen Collection
Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)
• Collect midstream urine samples
Collect midstream urine samples

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome	Evaluate the microbiome at baseline, one "good day" (minimal or no symptoms) and one "bad day" (worst symptoms) within a 6 month period	Within 6 month period from baseline evaluation