EPPIC: Easing Pelvic Pain Interventions Clinical Research Program

Recruiting now · Not applicable

Conditions studied: Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis, Bladder Pain Syndrome, Chronic Prostatitis, Chronic Pain, Chronic Pelvic Pain Syndrome, Chronic Overlapping Pain Disorders

In brief

The EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.

Key facts

Study ID: NCT05127616
Run by: State University of New York at Buffalo
People needed: 240
Starts: 2022-08-10
Expected to finish: 2028-07-31
Last updated by the study team: 2026-01-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ages 18-70 years (inclusive)
Male or female
All genders, races, ethnic groups
MD-confirmed diagnosis of IC/BPS or CP/CPPS by study urologist or urogynecologist
Pelvic pain including uncomfortable sensations of pressure or discomfort that are not described as outright pain) of at least six months duration
Pelvic pain intensity of at least moderate severity (defined as 3 or greater on a 0-10 Numerical Rating Scale and causes life interference weekly and limit(s) participant's life or work-related activities, general activity level, and/or enjoyment of life) over the past 3 months.
Ability to understand and provide informed consent
Either not taking medications or if taking medications willing to refrain from starting new medications until after the initial 2-week pre-treatment baseline period ends unless medically necessary.
A minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT 4)
Willing to be randomized to either CBT or Support/Education and to follow the protocol to which s/he has been assigned
Willing to be contacted for follow up assessments at week 12 and 3, 6 months after treatment ends
Willing to attend sessions
Able to maintain symptom diaries and complete paper work
Access to telephone and computer or smartphone
Willing and able to provide adequate information for locator purposes
Exclusion Criteria: Urologic-Specific
Presence of a neurological condition (e.g., MS, Parkinson's disease, paraplegia) affecting the bladder
The presence of a symptomatic urethral stricture (males only)
History of cystitis caused by tuberculosis or radiation or chemotherapies
Participant has been diagnosed and treated for a pelvic-related malignancy (colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer)
Exclusion Criteria: General
Participant has a medical condition(s) whose nature or severity (unstable, life threatening, etc.) would influence adversely the conduct of the clinical trial, confound interpretation of study results, and/or compromise volunteer safety and engagement with study demands.
Gross cognitive impairment, deafness, blindness, vision problems (severe), hearing problems (severe)
Has a major psychiatric disorder which would impede conduct of the clinical study. These clinical disorders would include but are not limited to 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 organic mental disorder
Current involvement in psychotherapy directed specifically toward relief of urological symptoms

Where it is running

University at Buffalo (the only clinical site where treatment is delivered) — Buffalo, New York, United States (enrolling)
UCLA — Los Angeles, California, United States
University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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