Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Recruiting now · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06299683

Run by

Vanderbilt University Medical Center

People needed

220

Starts

2024-05-01

Expected to finish

2028-04-04

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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).

Where it is running

• Vanderbilt Urology Cool Springs — Franklin, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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