Microbiome of Urologic Chronic Pelvic Pain Syndrome

NCT03027076 | Withdrawn

• 1 other identifier: NA_00089692
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

prostatitis; chronic prostatitis; chronic pelvic pain syndrome; interstitial cystitis; painful bladder syndrome; bladder pain syndrome; biomarkers; biological markers; bacteria; microbiome; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Men with UCPPS

Genitourinary Specimen Collection for microbiome evaluation

Procedure: Genitourinary Specimen Collection

Asymptomatic Men

Genitourinary Specimen Collection for microbiome evaluation

Procedure: Genitourinary Specimen Collection

Women with UCPPS

Collect midstream urine samples

Procedure: Collect midstream urine samples

Asymptomatic Women

Collect midstream urine samples

Procedure: Collect midstream urine samples

Interventions

Genitourinary Specimen Collection PROCEDURE

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

Asymptomatic Men; Men with UCPPS

Collect midstream urine samples PROCEDURE

Collect midstream urine samples

Asymptomatic Women; Women with UCPPS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community Sample

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Urine from male and female participants 2. Expressed prostatic secretions (EPS) from male participants

MeSH Terms

Conditions

Prostatitis; Cystitis, Interstitial; Inflammation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur L Burnett, MD, FACS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 20, 2017
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

US (1)