AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome.
Philip M Hanno, David Allen Burks, J Quentin Clemens...
https://pubmed.ncbi.nlm.nih.gov/21497847Actively Recruiting
Led by Vanderbilt University Medical Center · Updated on 2026-01-21
220
Participants Needed
1
Research Sites
52 weeks
Total Duration
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
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
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
Total: 1 location
1
Vanderbilt Urology Cool Springs
Franklin, Tennessee, United States, 37067
Actively Recruiting
L
Lindsey McKernan, PhD, MPH
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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