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New treatment option for Urologic Chronic Pelvic Pain Syndrome (UCPPS)
Official title EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
ClinicalTrials.gov ID: NCT05127616
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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
You likely can't join if
- 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...
- Participant has a medical condition(s) whose nature or severity (unstable, life threatening, etc.) would influence adversely the conduct of the...
See the full eligibility 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...
- 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 assigned by chance 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Ann Arbor, Michigan, United States
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Ann Arbor, Michigan, United States; Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.