RECRUITING

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Quick Facts

Study Start:2024-05-01
Study Completion:2028-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06299683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older;
  2. * Diagnosis of IC/BPS as indicated by structured assessments;
  3. * Capable of giving written informed consent;
  4. * Able to enroll for the duration of the study period;
  1. * Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke;
  2. * Current or history of diagnosis of primary psychotic or major thought disorder within the past five years;
  3. * Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years);
  4. * 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;
  5. * Non-English speaking;
  6. * 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;
  7. * Difficulties or limitations communicating over the telephone or via teleconferencing systems;
  8. * Any planned life events that would interfere with participating in the key elements of the study;
  9. * Any major active medical issues that could preclude participation;
  10. * Currently pregnant;
  11. * Currently being treated for cancer;
  12. * Cancer-related pain;
  13. * Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).

Contacts and Locations

Study Contact

Lindsey McKernan, PhD, MPH
CONTACT
615-875-9990
research.ocim@vumc.org

Principal Investigator

Lindsey McKernan, PhD, MPH
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt Urology Cool Springs
Franklin, Tennessee, 37067
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2028-08-04

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2028-08-04

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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