Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Part of paid clinical trials in Franklin, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06299683
Status
Recruiting
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Conditions

  • Bladder Pain Syndrome
  • Chronic Interstitial Cystitis
  • Chronic Prostatitis
  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome
  • Cystitis, Chronic Interstitial
  • Cystitis, Interstitial
  • Interstitial Cystitis
  • Interstitial Cystitis (Chronic) With Hematuria
  • Interstitial Cystitis (Chronic) Without Hematuria
  • Interstitial Cystitis, Chronic
  • Painful Bladder Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychosocial Treatment — BEHAVIORAL
    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.
  • Pelvic Floor Physical Therapy — OTHER
    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

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Jan 2026
Primary completion
Apr 5, 2027
Completion
Apr 4, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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

Primary Outcome Measure

Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale. [ Time Frame: Post-treatment (either Week 8 or 10) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt Urology Cool SpringsFranklinTennessee37067
Lindsey McKernan, PhD, MPH

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