EPPIC: Easing Pelvic Pain Interventions Clinical Research Program (EPPIC)
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis, Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Urologic Chronic Pelvic Pain Syndrome (UCPPS)
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
Sites / Locations
- UCLA
- University of Michigan
- University at Buffalo (the only clinical site where treatment is delivered)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Minimal Contact-Cognitive Behavior Therapy
Education/Support
CBT is a goal-focused, learning-based treatment that teaches practical self-management tools and strategies targeting biobehavioral factors that aggravate pelvic pain and urinary symptoms
EDU emphasizes the empowering therapeutic benefits that come from the common across empirically-validated drug or non-drug treatment such as being listened to, support, receipt of science-based information, mobilization of hope, and the establishment of a strong patient-doctor relationship working toward shared goals