Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Last updated: January 6, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Focal Segmental Glomerulosclerosis

Urinary Tract Infections

Treatment

Pelvic Floor Physical Therapy

Psychosocial Treatment

Clinical Study ID

NCT06299683
230487
1R01DK133415-01A1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Comorbid neurological conditions including spinal cord injury or systematicneurologic illnesses, or central nervous system diseases such as brain tumor orstroke;

  • Current or history of diagnosis of primary psychotic or major thought disorderwithin the past five years;

  • Hospitalization for psychiatric reasons other than suicidal ideation, homicidalideation, 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 activedelusional or psychotic thinking;

  • Difficulties or limitations communicating over the telephone or via teleconferencingsystems;

  • Any planned life events that would interfere with participating in the key elementsof 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).

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Pelvic Floor Physical Therapy
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
April 04, 2028

Study Description

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms and presentations vary widely. For these reasons, national organizations have prioritized the need to improve both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now identified that individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that different phenotypes of patients with IC/BPS respond differently to medical intervention. 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. The investigator is proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment (Aim 2). The investigator hypothesizes that a prediction of which participants will respond preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain outside of the pelvis). This project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.

Connect with a study center

  • Vanderbilt Urology Cool Springs

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

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