Urologic Chronic Pelvic Pain Syndrome (UCPPS)EPPICNCT05127616
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
A study testing Minimal Contact-Cognitive Behavior Therapy and Patient Education/Support in people with Urologic Chronic Pelvic Pain Syndrome (UCPPS) and Interstitial Cystitis, run by State University of New York at Buffalo at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Minimal Contact-Cognitive Behavior Therapy and Patient Education/Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Aug 2022to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
University of Michigan
Ann Arbor, Michigan, 48109-5330
- Recruiting
University at Buffalo (the only clinical site where treatment is delivered)
Buffalo, New York, 14215
Patricia O'Leary, MS Ed, 1(716)898-6254, pcoleary@buffalo.edu
- Active, not recruiting
UCLA
Los Angeles, California, 90095-7378
About this study
Official title: A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
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.
Read the detailed description
Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated. Their prolonged personal and economic costs are amplified by the frequent co-occurrence of a cluster of centralized pain conditions (particularly irritable bowel syndrome 3 [IBS]) but also fibromyalgia [FMS], chronic headache, chronic fatigue, etc.) called Chronic Overlapping Pain Conditions (COPC). Clinically, the notion that these syndromes share a centralized pain phenotype with a fundamental disturbance in pain or sensory processing dovetails with our preliminary research showing that a novel transdiagnostic behavioral treatment emphasizing a single common mechanistic pathway (i.e. inflexible cognitive style) reduces severity of both targeted (IBS) and untargeted multisymptom COPCs that include (but is not limited to) to UCPPS, FMS, chronic fatigue, and chronic headache. If effective in a larger scale study, a transdiagnostic UCPPS treatment would offer a more efficient, accessible, and broadly useful strategy for improving chronic pelvic pain and its most frequent and complicating comorbidities. To this end, the investigators will randomize 240 UCPPS subjects (18-70 yrs.) of any gender and race to a 4-session version of CBT that teaches skills for self-managing UCPPS symptoms (e.g. pelvic pain, urinary symptoms such as urinary frequency, urgency) with minimal clinician oversight (MC-CBT) or a four-session non-specific education/support control (EDU). Efficacy assessments will be administered at pre-treatment baseline and two weeks after the end of the 10-week acute phase using the patient version of the Clinical Global Impressions Scale and validated with the physician version rated by MD assessors blind to treatment assignment. The investigators hypothesize MC-CBT will deliver significantly greater UCPPS symptom improvement than EDU (Aim 1). Additional aims include characterizing the durability of effects 3- and 6 months post treatment (Aim 2). To increase the efficacy and efficiency of behavioral pain treatments, the investigators draw upon Beck's transdiagnostic cognitive model to characterize the precise cognitive procedures and corresponding operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT induced UCPPS symptom relief relative to EDU (Aim 3) as well as baseline patient variables that moderate differential response (Aim 3) with the ultimate goal of more proactive patient-treatment matching fundamental to the goals of personalized medicine. By applying innovative statistical modelling (e.g. dominance analysis, Randomized Explanatory Trial analyses) to study aims in the context of a rigorously designed behavioral trial, the researchers expand the portfolio of nondrug pain treatments for UCPPS and co-aggregating COPCs to include one whose brevity, convenience, and transdiagnostic design "meets patients where they are" and addresses the practical (access, complexity, cost), clinical (breadth, durability, magnitude of effects, patient preference) and conceptual (untargeted comorbidities, non-pain somatic symptoms) challenges that have impeded uptake and public health impact of evidence-based behavioral pain treatments at a time when our most vulnerable high impact pain patients are in greatest need.
- Conditions
- Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis, Bladder Pain Syndrome, Chronic Prostatitis, Chronic Pain, Chronic Pelvic Pain Syndrome
- Being tested
- Minimal Contact-Cognitive Behavior Therapy, Patient Education/Support
- Medical subject headings
- Cystitis, Interstitial, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Contact-Cognitive Behavior TherapyBehavioural
Also called MC-CBT
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/SupportBehavioural
Also called EDU
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Contact-Cognitive Behavior Therapy | Experimental | 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 Receives: Behavioral: Minimal Contact-Cognitive Behavior Therapy |
| Education/Support | Active comparator | 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 Receives: Behavioral: Patient Education/Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions - Improvement Scale Patient Version (CGI-I)
Widely used measure of global improvement of symptoms from baseline. To optimize rigor, clinician version by independent MD assessors "blind" to treatment assignment will also measure global severity of pelvic pain and urinary symptoms from baseline and validate patient-reported global improvement as a marker of clinical response. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
Measured: 12 weeks after pre-treatment baseline
Secondary outcomes (7)
Genitourinary Pain Index (GUPI)
9-item instrument of genitourinary pain including three subscales: pain, urinary, quality of life, and a total score. The GUPI includes a pain rating scale (assessed by a 0 to 10 numerical rating scale) which is a core outcome domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
Measured: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Problem Index (ICPI)
4-item questionnaire assessing problems caused by urinary and pelvic pain symptoms
Measured: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Symptom Index (ICSI)
4-item questionnaire of urinary and pelvic pain symptoms
Measured: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Brief Symptom Inventory (BSI 18)
18-item measure of anxiety, depression, somatization and overall distress. Emotional distress is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Measured: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS - Pain Interference SF-6a
6-item measure of consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Physical functioning is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Measured: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Client Satisfaction Questionnaire (CSQ)
8-item questionnaire of patient satisfaction with treatment services. Patient satisfaction is a core IMMPACT domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain
Measured: 12 weeks after pre treatment baseline
CHOIR Body Map
The CHOIR Body Map is a self-report measure designed to assess the degree of widespread pain. Participants are presented with a body figure (male or female) containing 36 anterior segments and 38 posterior segments on which the participants can endorse areas of pain. A total score is calculated by summing the number of endorsed areas of pain (range: 0 - 74).
Measured: Baseline, 12 weeks after pre-treatment baseline, 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Aug 2022
- Primary completionFeb 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urologic Chronic Pelvic Pain Syndrome (UCPPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Michigan
- Responsible party
- Principal investigator, Jeffrey Lackner, State University of New York at Buffalo
- Investigators
- Jeffrey Lackner, PsyD, Principal investigator, University at Buffalo (SUNY)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127616
- Sponsor's protocol ID
- STUDY00005691
- Other IDs
- NIH Grant/1R01DK128927
- Acronym
- EPPIC
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available for other researchers who wish to collaborate on specific analysis as requested after the investigators complete analyses and publication of study aims as well as to investigators who are conducting meta analyses. We will prepare detailed description of methods that make clear how the proposed study was rigorously executed and is reproducible.
Publications
Clemens JQ, Mullins C, Ackerman AL, Bavendam T, van Bokhoven A, Ellingson BM, Harte SE, Kutch JJ, Lai HH, Martucci KT, Moldwin R, Naliboff BD, Pontari MA, Sutcliffe S, Landis JR; MAPP Research Network Study Group. Urologic chronic pelvic pain syndrome: insights from the MAPP Research Network. Nat Rev Urol. 2019 Mar;16(3):187-200. doi: 10.1038/s41585-018-0135-5.
PubMed 30560936Leue C, Kruimel J, Vrijens D, Masclee A, van Os J, van Koeveringe G. Functional urological disorders: a sensitized defence response in the bladder-gut-brain axis. Nat Rev Urol. 2017 Mar;14(3):153-163. doi: 10.1038/nrurol.2016.227. Epub 2016 Dec 6.
PubMed 27922040Lackner JM, Jaccard J, Quigley BM, Ablove TS, Danforth TL, Firth RS, Gudleski GD, Krasner SS, Radziwon CD, Vargovich AM, Clemens JQ, Naliboff BD. Study 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). Trials. 2022 Aug 13;23(1):651. doi: 10.1186/s13063-022-06554-9.
PubMed 35964133
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes
- ClinicalTrials.gov ID
- NCT05127616
- Acronym / sponsor ID
- EPPIC / STUDY00005691
- Conditions
- Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis, Bladder Pain Syndrome, Chronic Prostatitis, Chronic Pain, Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Michigan
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated. Their prolonged personal and economic costs are amplified by the frequent co-occurrence of a cluster of centralized pain conditions (particularly irritable bowel syndrome 3 [IBS]) but also fibromyalgia [FMS], chronic headache, chronic fatigue, etc.) called Chronic Overlapping Pain Conditions (COPC). Clinically, the notion that these syndromes share a centralized pain phenotype with a fundamental disturbance in pain or sensory processing dovetails with our preliminary research showing that a novel transdiagnostic behavioral treatment emphasizing a single common mechanistic pathway (i.e. inflexible cognitive style) reduces severity of both targeted (IBS) and untargeted multisymptom COPCs that include (but is not limited to) to UCPPS, FMS, chronic fatigue, and chronic headache. If effective in a larger scale study, a transdiagnostic UCPPS treatment would offer a more efficient, accessible, and broadly useful strategy for improving chronic pelvic pain and its most frequent and complicating comorbidities. To this end, the investigators will randomize 240 UCPPS subjects (18-70 yrs.) of any gender and race to a 4-session version of CBT that teaches skills for self-managing UCPPS symptoms (e.g. pelvic pain, urinary symptoms such as urinary frequency, urgency) with minimal clinician oversight (MC-CBT) or a four-session non-specific education/support control (EDU). Efficacy assessments will be administered at pre-treatment baseline and two weeks after the end of the 10-week acute phase using the patient version of the Clinical Global Impressions Scale and validated with the physician version rated by MD assessors blind to treatment assignment. The investigators hypothesize MC-CBT will deliver significantly greater UCPPS symptom improvement than EDU (Aim 1). Additional aims include characterizing the durability of effects 3- and 6 months post treatment (Aim 2). To increase the efficacy and efficiency of behavioral pain treatments, the investigators draw upon Beck's transdiagnostic cognitive model to characterize the precise cognitive procedures and corresponding operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT induced UCPPS symptom relief relative to EDU (Aim 3) as well as baseline patient variables that moderate differential response (Aim 3) with the ultimate goal of more proactive patient-treatment matching fundamental to the goals of personalized medicine. By applying innovative statistical modelling (e.g. dominance analysis, Randomized Explanatory Trial analyses) to study aims in the context of a rigorously designed behavioral trial, the researchers expand the portfolio of nondrug pain treatments for UCPPS and co-aggregating COPCs to include one whose brevity, convenience, and transdiagnostic design "meets patients where they are" and addresses the practical (access, complexity, cost), clinical (breadth, durability, magnitude of effects, patient preference) and conceptual (untargeted comorbidities, non-pain somatic symptoms) challenges that have impeded uptake and public health impact of evidence-based behavioral pain treatments at a time when our most vulnerable high impact pain patients are in greatest need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Contact-Cognitive Behavior Therapy | Experimental | Behavioral: Minimal Contact-Cognitive Behavior TherapyCBT 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 |
| Education/Support | Active comparator | Behavioral: Patient Education/SupportEDU 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal Contact-Cognitive Behavior TherapyAlso: MC-CBTThis 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. | Behavioural | Minimal Contact-Cognitive Behavior Therapy |
| Patient Education/SupportAlso: EDUThis 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. | Behavioural | Education/Support |
Primary outcome
Clinical Global Impressions - Improvement Scale Patient Version (CGI-I)
Time frame: 12 weeks after pre-treatment baseline
Widely used measure of global improvement of symptoms from baseline. To optimize rigor, clinician version by independent MD assessors "blind" to treatment assignment will also measure global severity of pelvic pain and urinary symptoms from baseline and validate patient-reported global improvement as a marker of clinical response. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
7 secondary outcomes
Genitourinary Pain Index (GUPI)
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Problem Index (ICPI)
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Interstitial Cystitis Symptom Index (ICSI)
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Brief Symptom Inventory (BSI 18)
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
PROMIS - Pain Interference SF-6a
Time frame: Baseline, 12 weeks after pre treatment baseline, 3- and 6-month follow-up
Client Satisfaction Questionnaire (CSQ)
Time frame: 12 weeks after pre treatment baseline
CHOIR Body Map
Time frame: Baseline, 12 weeks after pre-treatment baseline, 3- and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 30560936Clemens JQ, Mullins C, Ackerman AL, Bavendam T, van Bokhoven A, Ellingson BM, Harte SE, Kutch JJ, Lai HH, Martucci KT, Moldwin R, Naliboff BD, Pontari MA, Sutcliffe S, Landis JR; MAPP Research Network Study Group. Urologic chronic pelvic pain syndrome: insights from the MAPP Research Network. Nat Rev Urol. 2019 Mar;16(3):187-200. doi: 10.1038/s41585-018-0135-5.
- Background: PubMed 27922040Leue C, Kruimel J, Vrijens D, Masclee A, van Os J, van Koeveringe G. Functional urological disorders: a sensitized defence response in the bladder-gut-brain axis. Nat Rev Urol. 2017 Mar;14(3):153-163. doi: 10.1038/nrurol.2016.227. Epub 2016 Dec 6.
- Derived from this study: PubMed 35964133Lackner JM, Jaccard J, Quigley BM, Ablove TS, Danforth TL, Firth RS, Gudleski GD, Krasner SS, Radziwon CD, Vargovich AM, Clemens JQ, Naliboff BD. Study 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). Trials. 2022 Aug 13;23(1):651. doi: 10.1186/s13063-022-06554-9.
- Individual participant dataSharing planned: Yes. Data will be made available for other researchers who wish to collaborate on specific analysis as requested after the investigators complete analyses and publication of study aims as well as to investigators who are conducting meta analyses. We will prepare detailed description of methods that make clear how the proposed study was rigorously executed and is reproducible.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Lackner, PsyD principal investigator
University at Buffalo (SUNY)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Contact-Cognitive Behavior Therapy and Patient Education/Support in people with Urologic Chronic Pelvic Pain Syndrome (UCPPS) and Interstitial Cystitis, run by State University of New York at Buffalo at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Lackner, PsyD (716-898-5671, lackner@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions - Improvement Scale Patient Version (CGI-I) (time frame: 12 weeks after pre-treatment baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127616, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.