Recruiting

Observational StudyPain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06299683

Conditions

Chronic Interstitial Cystitis

Bladder Pain Syndrome

Painful Bladder Syndrome

Cystitis, Interstitial

Cystitis, Chronic Interstitial

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psychosocial Treatment

Pelvic Floor Physical Therapy

Study Details

Brief 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

Study ID

NCT06299683

Start date

May 1, 2024

Status verified date

Jan, 2026

Completion date

Apr 4, 2028

Anticipated

Primary completion date

Apr 5, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

18 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 Criteria:

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).

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Psychosocial Treatment

Pelvic Floor Physical Therapy

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 and Locations

Central contacts

Lindsey McKernan, PhD, MPH

615-875-9990 research.ocim@vumc.org

Locations

Vanderbilt Urology Cool Springs

Recruiting

Franklin, Tennessee, United States, 37067

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-01-21.