What this study is
The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:
Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.
Participants will
- complete surveys about their bladder pain symptoms
- make behavioral changes that have been shown to improve bladder pain symptoms
- attend six (6) weekly acupuncture sessions
- attend six (6) weekly physical therapy sessions after finishing acupuncture
What's being tested
- Acupuncture
Intervention · OTHER
traditional and electroacupuncture
- Behavioral management
Intervention · BEHAVIORAL
based on American urologic association guidelines
- Physical therapy
Intervention · OTHER
pelvic floor with biofeedback
Study details
- Official title
- Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
- Sponsor
- University Hospitals Cleveland Medical Center
- Conditions
- Bladder Pain Syndrome · Interstitial Cystitis
- Enrolling
- 34 people
- Starts
- 2025-01-21
- Est. completion
- 2026-10
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladder pain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause"
- Negative urine culture
- Has completed cystoscopic evaluation for IC/BPS
You can't join if
- History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
- History of overactive bladder
- History of bleeding disorder or are currently on chronic anti-coagulation
- Post-void residual >100mL
- Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox
- Prior bladder augmentation
- Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
- Currently pregnant (if applicable, based on self-report)
- Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
- Non-English speaking and reading
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity Hospitals
Cleveland, Ohio, United States
- Gabriella Rustia, MD · Contact216-202-0597gabriella.rustia@uhhospitals.org
Recruiting
Study team
Sponsor
University Hospitals Cleveland Medical Center
Study ID STUDY20240374
Principal investigator
David Sheyn, MD
University Hospitals Cleveland Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.