Health Trials

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

ConditionsChronic Interstitial CystitisBladder Pain SyndromePainful Bladder SyndromeCystitis, InterstitialCystitis, Chronic InterstitialInterstitial CystitisInterstitial Cystitis, ChronicInterstitial Cystitis (Chronic) With HematuriaInterstitial Cystitis (Chronic) Without HematuriaChronic ProstatitisChronic Prostatitis With Chronic Pelvic Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Psychosocial Treatment
  • Pelvic Floor Physical Therapy

Treatment groups

220 Participants
are divided into 2 treatment groups

Locations

1
Vanderbilt Urology Cool Springs37067, FranklinTennessee, United States

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov