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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT01098292
Eligibility Criteria:
The eligibility criteria for both healthy controls and positive controls are based on the same set of criteria for the Urologic Chronic Pelvic Pain Syndrome (UCPPS) participants in the Trans-MAPP EP Study, with exception of additional criteria to exclude chronic pelvic pain symptoms and criteria to identify the co-morbid syndromes for the positive controls. All entry criteria are shown below; those specific to either healthy or positive control participants are so indicated.
Inclusion Criteria:
Participants are eligible for the Trans-MAPP Control Protocol if they meet the following general and gender-specific criteria listed below:
1. Participant has signed and dated the appropriate Informed Consent document.
2. Agreed to participate in Trans-MAPP Control Study procedures;
Inclusion Criteria for Healthy Controls only
1. Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.
2. Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.
3. Participant reports no urological symptoms that have been evaluated, but are still present.
Inclusion Criteria for Positive Controls only:
1\. Participant meets the validated criteria for one or more of the following conditions
1. Fibromyalgia (FM)
2. Irritable bowel syndrome (IBS)
3. Chronic fatigue syndrome (CFS)
Exclusion Criteria:
Individuals will not be eligible for enrollment in the Trans-MAPP Control Study if they meet any of the criteria:
1. Participant has an on-going symptomatic urethral stricture.
2. Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
3. Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.
4. Participant has augmentation cystoplasty or cystectomy.
5. Participant has a systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).
6. Participant has a history of cancer (with the exception of skin cancer).
7. 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).
8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
Exclusion Criteria for Males Only
1. Male participant diagnosed with unilateral orchialgia, without pelvic symptoms.
2. Male participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, or prostate cryosurgery or laser procedure.
Exclusion Criteria for Females Only:
1\) Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01098292
Study Brief:
Protocol Section:
NCT01098292