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RECRUITING
NCT06299683
NA

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Official title: Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2024-05-01

Completion Date

2028-04-04

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psychosocial Treatment

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.

OTHER

Pelvic Floor Physical Therapy

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)

Vanderbilt Urology Cool Springs

Franklin, Tennessee, United States