Assessing pain types in treating bladder pain syndrome

Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome

This study is trying to see how different types of bladder pain affect how well people with bladder pain syndrome respond to pelvic floor physical therapy and cognitive-behavioral therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Franklin, Tennessee)
• Trial ID: NCT06299683 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate how different phenotypes of interstitial cystitis/bladder pain syndrome (IC/BPS) affect responses to two therapies: pelvic floor physical therapy and cognitive-behavioral therapy. The study will involve a randomized mechanistic trial to identify which patients benefit from each treatment based on their pain distribution. By understanding the neurobiological mechanisms that may influence treatment outcomes, the research seeks to improve personalized care for individuals suffering from this debilitating condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with interstitial cystitis/bladder pain syndrome.

Not a fit: Patients with significant comorbid neurological or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective, personalized treatment options for patients with interstitial cystitis/bladder pain syndrome.

How similar studies have performed: While there is ongoing research in the field, this approach focusing on patient phenotypes in IC/BPS treatment is relatively novel.

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).

Where this trial is running

Franklin, Tennessee

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

Study contacts

• Principal investigator: Lindsey McKernan, PhD, MPH — Vanderbilt University Medical Center
• Study coordinator: Lindsey McKernan, PhD, MPH

Conditions Chronic Interstitial Cystitis; Bladder Pain Syndrome; Painful Bladder Syndrome; Cystitis, Interstitial; Cystitis, Chronic Interstitial; Interstitial Cystitis; Interstitial Cystitis, Chronic; Interstitial Cystitis With Hematuria