Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
RecruitingNot applicableNCT06299683
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.
Study details
- Official title
- Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
- Conditions
- Chronic Interstitial Cystitis
- Bladder Pain Syndrome
- Painful Bladder Syndrome
- Cystitis, Interstitial
- Cystitis, Chronic Interstitial
- Interstitial Cystitis
- Interstitial Cystitis, Chronic
- Interstitial Cystitis (Chronic) With Hematuria
- Interstitial Cystitis (Chronic) Without Hematuria
- Chronic Prostatitis
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- Interventions
- Behavioral: Psychosocial Treatment
- Other: Pelvic Floor Physical Therapy
- Sponsor
- Vanderbilt University Medical Center
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Start date
- 2024-05-01
- Primary completion
- 2027-04-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 18 years of age or older; * Diagnosis of IC/BPS as indicated by structured assessments; * Capable of giving written informed consent; * Able to enroll for the duration of the study period; Exclusion Criteria: * Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke; * Current or history of diagnosis of primary psychotic or major thought disorder within the past five years; * Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years); * Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months; * Non-English speaking; * Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking; * Difficulties or limitations communicating over the telephone or via teleconferencing systems; * Any planned life events that would interfere with participating in the key elements of the study; * Any major active medical issues that could preclude participation; * Currently pregnant; * Currently being treated for cancer; * Cancer-related pain; * Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06299683