Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Vanderbilt University Medical Center
220 participants
May 1, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria13
- 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).
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Interventions
The psychosocial self-management intervention consists of 8 weekly 50-minute individual visits with an assigned trained therapist. Sessions follow a structured protocol that has been developed with the patient population and tested in a prior study. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies.
The pelvic floor physical therapy condition consists of 10 weekly 45-minute individual visits with an assigned trained physical therapist. In IC/BPS, pelvic floor physical therapy (PT) uses manual manipulation to release localized muscle tension, trigger points, and correct other scars and restrictions to reduce pain and urgency symptoms. Specific techniques will include external connective tissue manipulation to the abdominal wall, back, buttocks and thighs, myofascial trigger point release, and internal transvaginal/transrectal treatment of the soft tissues of the pelvic floor with connective tissue and myofascial manipulation to pelvic floor musculature
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06299683