Microbiome of Urologic Chronic Pelvic Pain Syndrome
Withdrawn before enrolling
Conditions studied: Prostatitis, Chronic Prostatitis, Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
In brief
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).
Key facts
- Study ID
- NCT03027076
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2013-11-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-08-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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).
- 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).
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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