Recruiting

Pelvic Pain

Sponsor:

State University of New York at Buffalo

Code:

NCT05127616

Conditions

Urologic Chronic Pelvic Pain Syndrome (UCPPS)

Interstitial Cystitis

Bladder Pain Syndrome

Chronic Prostatitis

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Minimal Contact-Cognitive Behavior Therapy

Patient Education/Support

Study Details

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.

Conditions

Urologic Chronic Pelvic Pain Syndrome (UCPPS)

Interstitial Cystitis

Bladder Pain Syndrome

Chronic Prostatitis

Chronic Pain

Study ID

NCT05127616

Start date

Aug 10, 2022

Status verified date

Jan, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Minimal Contact-Cognitive Behavior Therapy

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

active comparator: Education/Support

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

Interventions

Minimal Contact-Cognitive Behavior Therapy

This 4 session largely home-based version of CBT with minimal therapist contact treatment is aimed at improving UCPPS symptoms by teaching symptom self-management skills that modify illness beliefs, information processing strategies, and reactions that aggravate pelvic pain and urinary symptoms.

Patient Education/Support

This 4 session largely home-based treatment is aimed at improving UCPPS symptoms through the provision of support and science-based information about UCPPS symptoms, how it is diagnosed, its causes, impacts, and triggers, treatment options and a collaborative relationship between the patient and clinician.

Primary outcome measure

  • Clinical Global Impressions - Improvement Scale Patient Version (CGI-I) [ Time Frame: 12 weeks after pre-treatment baseline ]

Central Contacts and Locations

Central contacts

Jeffrey Lackner, PsyD

716-898-5671lackner@buffalo.edu

Patricia O'Leary, EdM

716-898-6254pcoleary@buffalo.edu

Locations

University at Buffalo (the only clinical site where treatment is delivered)

Recruiting

Buffalo, New York, United States, 14215

Contacts

Patricia O'Leary, MS Ed

1(716)898-6254pcoleary@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-01-26.