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).
Procedure: Genitourinary Specimen Collection
Procedure: Collect midstream urine samples
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03027076
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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).
All locations for NCT03027076
United States (1)
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
View full eligibility
Tris trial is registered with FDA with number: NCT03027076. The sponsor of the trial is Johns Hopkins University and it is looking for 0 volunteers for the current phase.
Official trial title: Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome
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