NCT05127616 EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
| NCT ID | NCT05127616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Urologic Chronic Pelvic Pain Syndrome (UCPPS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-08-10 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2022-08-10 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jeffrey Lackner, PsyD
PRINCIPAL INVESTIGATOR
University at Buffalo (SUNY)
Frequently Asked Questions
Who can join the NCT05127616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Urologic Chronic Pelvic Pain Syndrome (UCPPS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05127616 currently recruiting?
Yes, NCT05127616 is actively recruiting participants. Contact the research team at lackner@buffalo.edu for enrollment information.
Where is the NCT05127616 trial being conducted?
This trial is being conducted at Los Angeles, United States, Ann Arbor, United States, Buffalo, United States.
Who is sponsoring the NCT05127616 clinical trial?
NCT05127616 is sponsored by State University of New York at Buffalo. The principal investigator is Jeffrey Lackner, PsyD at University at Buffalo (SUNY). The trial plans to enroll 240 participants.