EPPIC: Easing Pelvic Pain Interventions Clinical Research Program

Launched by STATE UNIVERSITY OF NEW YORK AT BUFFALO · Nov 16, 2021

Keywords

ClinConnect Summary

The EPPIC study, which stands for Easing Pelvic Pain Interventions Clinical Research Program, is looking at a short, four-session therapy designed to help people with various types of chronic pelvic pain, including conditions like Interstitial Cystitis and Chronic Prostatitis. This new approach aims to be easier for both patients and doctors to use compared to longer treatments, which can be complicated and hard to access. The goal is to reduce pain, improve quality of life, and make treatment more affordable and accessible.

To join the study, participants should be between 18 and 70 years old and have a doctor-confirmed diagnosis of pelvic pain that has lasted for at least six months. They should be experiencing moderate to severe discomfort that affects their daily life. Participants will need to attend therapy sessions and keep track of their symptoms. The study is currently recruiting and welcomes individuals of all genders and backgrounds. If you're considering joining, you'll have the chance to contribute to important research that could help many others dealing with similar pain issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Schedule does not permit participation in clinic sessions or home practice including plans to move out of the area, lack of reliable transportation, etc.
• • Characteristics related to inability to complete the study protocol
• • Unable to read or fluently speak English
• • Inability to complete screening visits
• • Inaccessible for interventions and/or follow up evaluations