Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

This study is looking at how different types of pain in people with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) affect their response to two common treatments. Researchers want to see if people with different pain patterns respond better to either Psychosocial Treatment (a type of behavioral therapy) or Pelvic Floor Physical Therapy. You could be eligible if you are 18 or older, have an IC/BPS diagnosis, and can commit to the study. The study will measure success by looking at how much your symptoms improve after treatment, using a scale called the Global Response Assessment (GRA). The current recruitment status is unclear, and the study plans to enroll 220 participants.

Study design: This interventional study plans to enroll 220 participants. It is not specified if it is randomized or blinded.
What's involved: You would have 8 weekly 50-minute individual sessions for Psychosocial Treatment or 10 weekly 45-minute individual sessions for Pelvic Floor Physical Therapy.
Compensation: Not stated in the trial record.
Follow-up: Your response to treatment will be measured at the end of treatment (either Week 8 or 10).

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Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Recruiting

NAAges 18+InterventionalTreatment

Vanderbilt University Medical Center

~220 participants

Updated 2026-01-21 on ClinicalTrials.gov

What's tested:Psychosocial TreatmentPelvic Floor Physical Therapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.

Measured over Post-treatment (either Week 8 or 10)

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

Where it's being run

1 sites across 1 states

Tennessee1

Study leadership

Lindsey McKernan, PhD, MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Lindsey McKernan, PhD, MPH

[email protected]

615-875-9990

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.Post-treatment (either Week 8 or 10)
GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA\<3) within each treatment and phenotype.

Trialytics