Skip to main content
. 2022 Aug 13;23:651. doi: 10.1186/s13063-022-06554-9

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