Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

NCT06299683 | Recruiting DMC

• 2 other identifiers: 2304871R01DK133415-01A1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.

  GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA\<3) within each treatment and phenotype.

  Post-treatment (either Week 8 or 10)

Secondary Outcomes (7)

• Chronic Overlapping Pain Condition-Screener (COPCS)

  Baseline (Week 0)

• Quantitative Sensory Testing - Tolerance Average (QST-TOL)

  Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)

• Quantitative Sensory Testing - Threshold Average (QST-THR)

  Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)

• Quantitative Sensory Testing - Temporal Summation (QST-TS)

  Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)

• Urinary Nerve Growth Factor (NGF)

  Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)

Study Arms (2)

Psychosocial Treatment

EXPERIMENTAL

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.

Behavioral: Psychosocial Treatment

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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

Other: Pelvic Floor Physical Therapy

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.

Psychosocial Treatment

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

Pelvic Floor Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt Urology Cool Springs

Franklin, Tennessee, 37067, United States

RECRUITING

Related Publications (8)

• Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.

  PMID: 21497847 BACKGROUND

• Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.

  PMID: 26535150 BACKGROUND

• Sherman AL, Morris MC, Bruehl S, Westbrook TD, Walker LS. Heightened Temporal Summation of Pain in Patients with Functional Gastrointestinal Disorders and History of Trauma. Ann Behav Med. 2015 Dec;49(6):785-92. doi: 10.1007/s12160-015-9712-5.

  PMID: 25967582 BACKGROUND

• Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.

  PMID: 26856520 BACKGROUND

• Li J, Simone DA, Larson AA. Windup leads to characteristics of central sensitization. Pain. 1999 Jan;79(1):75-82. doi: 10.1016/S0304-3959(98)00154-7.

  PMID: 9928779 BACKGROUND

• Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR, Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003 Mar 25;60(6):898-904. doi: 10.1212/01.wnl.0000058546.16985.11.

  PMID: 12654951 BACKGROUND

• Ezenwa MO, Molokie RE, Wang ZJ, Yao Y, Suarez ML, Pullum C, Schlaeger JM, Fillingim RB, Wilkie DJ. Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? Pain Pract. 2016 Mar;16(3):282-93. doi: 10.1111/papr.12279. Epub 2015 Jan 12.

  PMID: 25581383 BACKGROUND

• Schrepf A, Maixner W, Fillingim R, Veasley C, Ohrbach R, Smith S, Williams DA. The Chronic Overlapping Pain Condition Screener. J Pain. 2024 Jan;25(1):265-272. doi: 10.1016/j.jpain.2023.08.009. Epub 2023 Aug 24.

  PMID: 37633574 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial; Bronchiolitis Obliterans Syndrome; Prostatitis; Pelvic Pain

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lindsey McKernan, PhD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey McKernan, PhD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 4, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)