Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

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.

Conditions

• 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

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

Sponsors & Collaborators

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

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2027-04-05

Completion

2028-04-04

Countries

• United States

Study Locations