Actively Recruiting
Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
Led by University Hospitals Cleveland Medical Center · Updated on 2026-01-08
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if acupuncture combined with behavioral changes can better treat women with bladder pain syndrome, also called interstitial cystitis, who have not received other treatments. The main focus is to see if acupuncture improves pain symptoms measured by the Interstitial Cystitis Index. The study compares six weeks of behavioral management alone to behavioral management combined with acupuncture. Participants will either receive verbal and written instructions on diet and urinary habit changes along with six weekly one-hour acupuncture sessions followed by pelvic floor physical therapy or they will first have six weeks of behavioral management before starting pelvic floor physical therapy. The acupuncture used includes traditional and electroacupuncture, and the physical therapy involves pelvic floor therapy with biofeedback. During the study, participants will complete surveys about their bladder pain symptoms and make behavioral changes that may help reduce symptoms. They will be monitored using the O'Leary-Sant Interstitial Cystitis Index at baseline and regularly during and after treatment for up to a year. Additional assessments include patient global impressions, quality of life surveys, and pain indexes. Researchers will also track any additional treatments and unscheduled interactions. The study lasts about one year after treatment to observe long-term outcomes.
CONDITIONS
Brief Title
Acupuncture First for IC/BPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets American Urologic Association criteria for interstitial cystitis/bladder pain syndrome: unpleasant bladder-related sensation with lower urinary tract symptoms for more than 6 weeks without other cause
- Negative urine culture
- Completed cystoscopic evaluation for interstitial cystitis/bladder pain syndrome
- Age between 18 and 89 years
You will not qualify if you...
- 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 current chronic anti-coagulation
- Post-void residual volume greater than 100 mL
- Prior treatments like acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation, sacral neuromodulation, or intradetrusor Botox
- Prior bladder augmentation
- Current or planned treatment for urologic or gynecologic cancer
- Current pregnancy
- Implanted pacemaker, defibrillator, or metallic implants below the umbilicus
- Non-English speaking and reading
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive six weekly one-hour acupuncture sessions followed by pelvic floor physical therapy, or they receive behavioral management for six weeks before starting pelvic floor physical therapy.
6 weekly visits for acupuncture group; weekly visits for behavioral management group
Duration - 52 weeks
Participants are monitored for one year after treatment to assess outcomes and any additional treatments or unscheduled interactions.
Monthly visits during the post-treatment period
Trial Site Locations
Total: 1 location
1
University Hospitals
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
J
Jessica Abou Zeki
G
Gabriella Rustia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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