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:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT01676857
Eligibility Criteria:
Inclusion Criteria:
* CP/CPPS group inclusion criteria
Patients are eligible for the study if they meet the following criteria:
* Participant has signed and dated the appropriate Informed Consent document.
* Agreed to participate in Study procedures.
* Participant is at least 18 years of age.
* Participant reports a response of at least 1 on the pain, pressure or discomfort scale (SYM-Q, Question #1).
* Participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index (MGUPI) (items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d).
* These CP/CPPS symptoms been present for the majority of the time during any 3 months in the previous 6 months.
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 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 diagnosed with unilateral orchialgia, without pelvic symptoms.
* Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
Control group exclusion criteria In addition to the exclusion criteria listed above additional criteria for control subjects are as follows.
1. In the past year, symptoms of discomfort or pain in the pelvic region for extended periods of time.
2. Volunteers who have had a urinary tract infection with a urine culture value of \>100,000 CFU/ml within the past three months.
3. Volunteers treated with intravesical chemotherapy or BCG.
4. Volunteers who have had any of the following sexually transmitted diseases (STDs) - gonorrhea, chlamydia, mycoplasma or trichomonas.
5. Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01676857
Study Brief:
Protocol Section:
NCT01676857