Four sessions at home may tame pelvic pain without pills
NCT ID NCT05127616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a brief, 4-session cognitive behavioral therapy (CBT) program for people with urologic chronic pelvic pain syndrome (UCPPS), including interstitial cystitis and chronic prostatitis. The treatment is mostly home-based with minimal therapist contact, teaching skills to manage pain and urinary symptoms. Researchers aim to enroll 240 adults aged 18–70 with moderate pelvic pain lasting at least six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cognitive behavioral therapy (CBT)
- What this could lead to
- If it works, this could offer a quick, low-cost way to manage chronic pelvic pain without drugs or surgery.
- What could go wrong
- This is a behavioral intervention, not a cure. Results depend on patient engagement, and the study is still recruiting, so outcomes are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA
ACTIVE_NOT_RECRUITINGLos Angeles, California, 90095-7378, United States
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University at Buffalo (the only clinical site where treatment is delivered)
RECRUITINGBuffalo, New York, 14215, United States
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University of Michigan
ACTIVE_NOT_RECRUITINGAnn Arbor, Michigan, 48109-5330, United States
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