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Search / Trial NCT06366269

Acupuncture First for IC/BPS

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Apr 10, 2024

Trial Information

Current as of June 24, 2025

Recruiting

Keywords

Acupuncture Bladder Pain Syndrome Interstitial Cystitis

ClinConnect Summary

This clinical trial, called "Acupuncture First for IC/BPS," is looking to find out if adding acupuncture to behavioral changes can help women with bladder pain syndrome, also known as interstitial cystitis, who haven't tried other treatments yet. The main goal is to see if acupuncture can reduce pain symptoms better than just making lifestyle changes alone. Participants will be asked to fill out surveys about their bladder pain, make certain behavioral adjustments that may help, and attend six weekly acupuncture sessions followed by six weekly physical therapy sessions.

To join this study, participants need to meet specific criteria, which include having pain related to the bladder for more than six weeks, with no other known causes. They should not have a history of recurrent urinary tract infections or certain other medical conditions that could interfere with the study. This trial is currently recruiting participants aged 18 and older of any gender, and it aims to provide new insights into effective treatments for bladder pain syndrome.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About University Hospitals Cleveland Medical Center

University Hospitals Cleveland Medical Center is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with Case Western Reserve University, the center integrates cutting-edge medical education, comprehensive patient care, and pioneering clinical trials to enhance treatment options and improve patient outcomes. With a diverse range of specialized programs and a robust infrastructure for research, University Hospitals Cleveland Medical Center plays a vital role in translating scientific discoveries into effective therapies, ensuring access to the latest advancements in medicine for patients and communities.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

David Sheyn, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported