Urologic chronic pelvic pain syndrome: insights from the MAPP Research Network.
J Quentin Clemens, Chris Mullins, A Lenore Ackerman...
https://pubmed.ncbi.nlm.nih.gov/30560936Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05127616
A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
Led by State University of New York at Buffalo · Updated on 2026-01-26
240
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
State University of New York at Buffalo
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a brief cognitive behavioral therapy (CBT) program designed to reduce symptoms of urologic chronic pelvic pain syndrome (UCPPS), which includes conditions like interstitial cystitis/bladder pain syndrome and chronic prostatitis. This research explores a shorter, 4-session transdiagnostic behavioral treatment that may be easier for patients, providers, and payers to use compared to longer traditional therapies. The study also aims to understand how this therapy works and who benefits most, especially given the high costs and widespread impact of related chronic pain conditions. Participants will be randomly assigned to receive either a minimal contact CBT involving four sessions focused on teaching self-management skills for pelvic pain and urinary symptoms or a four-session education/support program providing science-based information and therapeutic support. Both treatments are largely home-based with minimal therapist contact. The study measures treatment effects at baseline, after 12 weeks, and at 3- and 6-month follow-ups to assess symptom improvements and treatment durability. During the study, participants will complete various assessments including symptom diaries, validated questionnaires for pain and psychological symptoms, and satisfaction surveys. The primary outcome is the Clinical Global Impressions Improvement Scale measured 12 weeks after baseline. Researchers also evaluate secondary outcomes like pain impact, symptom severity, and psychological distress. Follow-up assessments occur up to 6 months post-treatment to monitor ongoing effects and participant progress over time.
CONDITIONS
Brief Title
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 18-70 years (inclusive)
- Male or female
- All genders, races, ethnic groups
- MD-confirmed diagnosis of interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome by a study urologist or urogynecologist
- Pelvic pain or discomfort lasting at least six months
- Pelvic pain intensity of moderate severity or higher (3 or greater on a 0-10 scale) causing weekly interference with life or work activities
- Ability to understand and provide informed consent
- Either not taking medications or willing to avoid starting new medications until after the 2-week pre-treatment baseline period unless medically necessary
- Minimum 6th grade reading level
- Willing to be randomized to either cognitive behavioral therapy or education/support
- Willing to attend sessions and complete study activities including symptom diaries and paperwork
- Access to telephone and computer or smartphone
- Willing and able to provide locator information
- Willing to be contacted for follow-up assessments at 12 weeks, 3 months, and 6 months after treatment
You will not qualify if you...
- Presence of neurological conditions affecting the bladder (e.g., MS, Parkinson's disease, paraplegia)
- Symptomatic urethral stricture (males only)
- History of cystitis caused by tuberculosis, radiation, or chemotherapy
- Diagnosis and treatment for pelvic-related malignancies such as colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer
- Medical conditions that are unstable, life-threatening, or could interfere with study participation or safety
- Severe cognitive impairment, deafness, blindness, or severe vision or hearing problems
- Major psychiatric disorders that impede study participation, including recent substance abuse, schizophrenia, or severe depression with suicide risk
- Current psychotherapy aimed specifically at urological symptoms
- Scheduling conflicts or lack of reliable transportation
- Inability to complete the study protocol
- Unable to read or speak English fluently
- Unable to complete screening visits or follow-up evaluations
- Inaccessible for interventions or follow-up assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 weeks
Participants receive a 4-session, home-based treatment over 10 weeks teaching self-management skills for urological chronic pelvic pain syndrome or receive education/support sessions.
4 sessions (in-person or remote)
Follow-up
Duration - Up to 6 months after treatment
Participants complete efficacy and symptom assessments at 12 weeks, with additional follow-ups at 3 and 6 months to evaluate symptom durability.
3 visits (post-treatment assessments at 12 weeks, 3 months, and 6 months)
Trial Site Locations
Total: 3 locations
1
UCLA
Los Angeles, California, United States, 90095-7378
Active, Not Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109-5330
Active, Not Recruiting
3
University at Buffalo (the only clinical site where treatment is delivered)
Buffalo, New York, United States, 14215
Actively Recruiting
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Research Team
J
Jeffrey Lackner, PsyD
P
Patricia O'Leary, EdM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Functional urological disorders: a sensitized defence response in the bladder-gut-brain axis.
Carsten Leue, Joanna Kruimel, Desiree Vrijens...
https://pubmed.ncbi.nlm.nih.gov/27922040Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS).
Jeffrey M Lackner, James Jaccard, Brian M Quigley...
https://pubmed.ncbi.nlm.nih.gov/35964133