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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT01616992
Eligibility Criteria:
General exclusion criteria for all IC/PBS and MPP patients, their siblings, and normal subjects will include presence of:
1. Currently attempting to become pregnant, pregnant (pregnancy test will be required) or breast feeding
2. Hematuria (? this can occur in IC) or infection on urinalysis
3. Recurrent urinary tract infections (\> 3 culture documented episodes within the previous 12 months)
4. Pelvic or bladder neoplasm or infection
5. Inflammatory arthritis, connective tissue or auto-immune disorder
6. Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.).
7. Neuropathy, central nervous system disorder (e.g., Parkinson's Disease, Alzheimer's, MS, stroke, etc)
8. Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
9. Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
10. Regular use of opiods
11. Allergy to lidocaine
12. Inability to stop use of autonomically active or pro-kinetic (gastrointestinal motility modifying) agents for a minimum of 5 half-lives prior to testing
13. Current substance abuse or \> 10 alcoholic beverages per week
14. Any major surgical intervention with general anesthesia in the last 90 days
15. Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
16. Any condition that in the judgment of the investigator and the internal advisory panel would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented) 17.Investigators, study staff and their immediate families 18.Inability to speak English
19\) Previously completed or withdrawn from this study
Normal controls and siblings: Aged-matched healthy female subjects will be recruited by nomination by patients and advertisement. A history and physical will be obtained by a physician, and controls will be required to have no history, symptoms or signs of (exclusion criteria):
1. FM or CFS (unexplained fatigue for a period of 6 months or more)
2. IC/PBS, MPP or chronic pelvic discomfort or chronic pain disorder of any type.
3. One of the other ODYSA dysautonomias
IC/PBS Patients - The diagnosis of IC/PBS will be made using most current NIDDK criteria. Exclusion criteria:
1. Intravesical therapy or bladder hydrodistention within the previous 90 days
2. Initiation of pentosan polysulfate sodium (Elmiron) within the previous 90 days
3. Previous augmentation cystoplasty, cystectomy or cytolysis, neurectomy (i.e., hypogastric nerve plexus ablation) or implanted neural stimulator which is functionally "on", in active use, or unable to be turned functionally off throughout the study period.
MPP Patients - Inclusion Criteria
1. CPP \> 3 months duration, with pain ranked \> 3/10 by oral analog scale
2. Presence of 1 or more palpable trigger points on transvaginal and/or transrectal examination of the pelvic floor, which reproduces the pain for which they are seeking medical care.
Exclusion criteria:
1. Pelvic surgery within the last 12 months
2. Pelvic injection with the last 90 days
3. Presence of IC/PBS by the current NIDDK criteria
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01616992
Study Brief:
Protocol Section:
NCT01616992