Table 1 Participant inclusion and exclusion criteria
Rationale | |
|---|---|
Inclusion criteria | |
Ages 18–70 years inclusive | Matches developmental correlates of treatments and outcome domains |
Males and females of any race, ethnicity, and gender | Includes the full range of individuals diagnosed with UCPPSs |
Formal diagnosis of IC/BPS or CP/CPPS (confirmed by urologist or urogynecologist) | Optimizes construct validity of disorders of interest |
Pelvic pain (including pressure or discomfort) of at least 6 months duration | Establish that pelvic pain is chronic, not acute |
Pelvic pain intensity of at least moderate severity (defined as 3 or greater on a 0–10 scale and limits participant’s life or work-related activities) over the past 3 months | Establish that UCPPS symptoms are sufficiently clinically significant to detect improvement |
Not taking medications and/or willing to refrain from starting new medications until after the initial 2-week baseline period ends unless medically necessary | Stabilization of baseline symptoms and confounding of treatment effects |
Urologic exclusion criteria | |
Presence of a neurological condition (e.g., multiple sclerosis Parkinson’s disease, paraplegia) affecting the bladder | Urological symptoms due to, or possibly result of, a specific disease condition that may require different treatment |
Presence of a symptomatic urethral stricture (males only) | Urological symptom due to, or possibly result of, a specific disease condition |
History of cystitis caused by tuberculosis or radiation or chemotherapies | Urological symptom due to, or possibly result of, a specific disease condition |
Previous diagnosis and treatment for a pelvic-related malignancy (e.g., colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer) | Condition/circumstance might confound treatment effects or interpretation of data |
General exclusion criteria | |
Existing medical condition(s) whose nature or severity could adversely influence the conduct of the clinical trial or compromise volunteer safety | Condition/circumstance might confound treatment effects or interpretation of data or compromise safety |
Gross cognitive impairment, deafness, blindness, severe vision or hearing problems | Condition may make it difficult to attend sessions or complete home assignments |
Presence of a major psychiatric disorder that would impede conduct of the clinical study [major depression with a high risk of suicidal behavior (i.e., intent or plan); current or recent (within the past 3 months) history of alcohol or substance abuse/dependence; a lifetime history of schizophrenia or schizoaffective disorder; or an organic mental disorder] | Condition might confound treatment effects or interpretation of data or compromise safety |
Current involvement in psychotherapy directed specifically toward relief of urological symptoms | Possible bias due to exposure to experimental procedures |
Unable to read or fluently speak English | Condition would make it difficult for fully informed consent or to participate in study |