Clinical trial NCT06299683: Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Official title: Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: interstitial cystitis
bladder pain syndrome
clinical trial
psychosocial intervention
pelvic pain
therapy
urological chronic pelvic pain syndrome
chronic prostatitis
self-management
cognitive behavioral therapy
pelvic floor physical therapy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-03-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.
timeFrame: Post-treatment (either Week 8 or 10)
Secondary outcomes:
measure: Chronic Overlapping Pain Condition-Screener (COPCS)
timeFrame: Baseline (Week 0)
measure: Quantitative Sensory Testing - Tolerance Average (QST-TOL)
timeFrame: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
measure: Quantitative Sensory Testing - Threshold Average (QST-THR)
timeFrame: Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
measure: Quantitative Sensory Testing - Temporal Summation (QST-TS)
timeFrame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
measure: Urinary Nerve Growth Factor (NGF)
timeFrame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
measure: Urinary Interleukin-6 (IL6)
timeFrame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
measure: Interleukin-6, whole blood stimulated (IL6-LPS)
timeFrame: Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Vanderbilt Urology Cool Springs
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lindsey McKernan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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