Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT02898220
Eligibility Criteria:
Inclusion Criteria:
* Participant has signed and dated the appropriate Informed Consent document.
* Agreed to participate in ALL required study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
* Gave permission for use of DNA for genetics studies.
* Gender recorded in Participant Registration module.
* Participant is at least 18 years of age.
* Participant is able to speak, read, and understand English.
* Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale (SYM-Q, Question #1).
* Participant reports no chronic pain in the pelvic or bladder region, and reports no chronic pain in any other body region.
* Participant reports no urological symptoms that have been evaluated, but are still present.
Exclusion Criteria:
* Participant has an on-going symptomatic urethral stricture.
* Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
* Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.
* Participant has augmentation cystoplasty or cystectomy.
* Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
* Participant has a history of cancer (with the exception of skin cancer).
* 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.).
* Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
* Participant has had definitive treatment for acute epididymitis, urethritis, vaginitis.
* Participant has history of unevaluated hematuria, this will require the evaluation of a study physician to determine if this has been appropriately evaluated.
* Participant has had a cystoscopy with hydrodistention or kenalog injection.
Exclusion Criteria for Males Only:
* Diagnosis of unilateral orchalgia, without pelvic symptoms.
* History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
* A prostate biopsy or transurethral resection of the prostate (TURP) within the last three months.
Exclusion Criteria for Females Only:
• Participant has a positive Urine pregnancy test.
Specimen Exclusion Criteria (Males and Females):
• Participant has a positive dipsticParticipant has a positive urine culture.
Fatigue Symptom Eligibility Criteria:
* Participant, for at least 3 months in the past year, has persistent fatigue not relieved with rest.
* Participant, for at least 3 months in the past year, has extreme fatigue following exercise or mild exertion.
* Participant, for at least 3 months in the past year, has impaired memory, concentration or attention.
Exclusion Criteria - Urine test results:
A clean-catch midstream urine specimen (VB2) will be obtained from all male and female participants during the initial and 6 month study visits, so that a urine dipstick analysis can be done for all participants, and a urine pregnancy test can be conducted for females of child bearing age excluding those who are post-menopausal and those with a history of hysterectomy.
* If participant has an abnormal dipstick urinalysis indicating abnormal levels of nitrites and/or occult blood, that in the opinion of the Principal Investigator warrants exclusion, participant will be ineligible for study participation at the initial visit and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being withdrawn.
* If participant has had a positive urine culture in the past 6 weeks, or currently has a midstream urine culture (VB2) (\>100,000 CFU/ml), with a single uropathogen, the participant will be ineligible for the study at the initial visit, treated and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being treated and withdrawn. (Must be documented on Urine Culture Result - UCR form). We will keep all specimens and data collected from both eligible and in-eligible participants unless participant request that his/her data be destroyed, and not utilized for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02898220
Study Brief:
Protocol Section:
NCT02898220