Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06299683

Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome Evaluating Pelvic Floor Physical Therapy and Cognitive-Behavioral Therapy

Led by Vanderbilt University Medical Center · Updated on 2026-01-21

220

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a condition called interstitial cystitis/bladder pain syndrome (IC/BPS), which causes severe pain and affects millions in the United States. This condition is difficult to treat because symptoms vary widely, and emotional distress can worsen physical pain. The study aims to understand how different types of IC/BPS pain, or "phenotypes," affect responses to two common therapies: pelvic floor physical therapy and cognitive-behavioral therapy (CBT). This research hopes to tailor treatments based on individual pain patterns for better care in the future. The study compares two treatment approaches for IC/BPS. One group receives pelvic floor physical therapy involving 10 weekly 45-minute sessions with a trained physical therapist, focusing on manual techniques to ease muscle tension and reduce symptoms. The other group receives psychosocial treatment with 8 weekly 50-minute individual visits with a trained therapist, covering pain coping, relaxation, education, and communication skills. These therapies are given in separate periods, and the study uses random assignment to place participants in one of these treatments. Participants will be involved in individual therapy or physical therapy sessions each week for 8 to 10 weeks. Researchers will assess treatment response using the Global Response Assessment scale shortly after therapy ends. Additional tests will measure pain sensitivity, nerve growth factors, and inflammatory markers before, after, and six months following treatment. The study also monitors emotional and physical health throughout. Overall participation lasts several months, including follow-up visits to understand long-term effects and treatment outcomes.

CONDITIONS

Brief Title

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosis of IC/BPS confirmed by structured assessments
  • Able to provide written informed consent
  • Able to participate for the full duration of the study
Not Eligible

You will not qualify if you...

  • Neurological conditions such as spinal cord injury, brain tumor, stroke, or systemic neurological illnesses
  • Diagnosis of primary psychotic or major thought disorder within the past five years
  • Psychiatric hospitalization within the past five years, except for suicidal ideation, homicidal ideation, or PTSD
  • Unstable or severe psychiatric or behavioral conditions within the past six months
  • Non-English speaking
  • Current symptoms that interfere with participation, including active suicidal or homicidal ideation or psychotic thinking
  • Difficulties communicating by telephone or teleconferencing
  • Planned life events that would interfere with study participation
  • Major active medical issues preventing participation
  • Currently pregnant
  • Currently being treated for cancer or experiencing cancer-related pain
  • Recent or active participation in similar treatments such as individual psychotherapy or pelvic floor physical therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 to 10 weeks

Participants receive either psychosocial self-management therapy or pelvic floor physical therapy. Psychosocial therapy includes 8 weekly 50-minute individual sessions with a trained therapist focusing on pain coping, relaxation, education, and communication. Pelvic floor physical therapy includes 10 weekly 45-minute individual sessions with a trained physical therapist using manual techniques to relieve muscle tension and reduce symptoms.

8 weekly visits for psychosocial therapy or 10 weekly visits for pelvic floor physical therapy

Follow-up

Duration - Up to 16 weeks after treatment

Participants are monitored for outcomes and changes after completing treatment, including assessments at Week 24.

1 visit at Week 24 (in-person)

Trial Site Locations

Total: 1 location

1

Vanderbilt Urology Cool Springs

Franklin, Tennessee, United States, 37067

Actively Recruiting

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Research Team

L

Lindsey McKernan, PhD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Heightened Temporal Summation of Pain in Patients with Functional Gastrointestinal Disorders and History of Trauma.

Amanda L Sherman, Matthew C Morris, Stephen Bruehl...

https://pubmed.ncbi.nlm.nih.gov/25967582

Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain.

Angela R Starkweather, Amy Heineman, Shannon Storey...

https://pubmed.ncbi.nlm.nih.gov/26856520

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

M E Shy, E M Frohman, Y T So...

https://pubmed.ncbi.nlm.nih.gov/12654951

Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain?

Miriam O Ezenwa, Robert E Molokie, Zaijie Jim Wang...

https://pubmed.ncbi.nlm.nih.gov/25581383