Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06299683

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Led by Vanderbilt University Medical Center · Updated on 2026-01-21

220

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 with unstable or severe symptoms in past six months (e.g., delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency)
  • Non-English speaking
  • Presenting symptoms interfering with participation such as active suicidal ideation with intent or active delusional or psychotic thinking
  • Difficulties or limitations communicating over telephone or teleconferencing
  • Any planned life events interfering with study participation
  • 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 physical therapy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Vanderbilt Urology Cool Springs

Franklin, Tennessee, United States, 37067

Actively Recruiting

Loading map...

Research Team

L

Lindsey McKernan, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here