Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID06366269

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

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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 - 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

Follow-up

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

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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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