Acupuncture First for IC/BPS

Last updated: February 6, 2025
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Bladder Disorders

Gynecological Infections

Treatment

Acupuncture

Physical therapy

Behavioral management

Clinical Study ID

NCT06366269
STUDY20240374
  • Ages 18-89
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladderpain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort)perceived to be related to the urinary bladder, associated with lower urinary tractsymptoms of more than 6 weeks duration, in the absence of other identifiable cause"

  • Negative urine culture

  • Has completed cystoscopic evaluation for IC/BPS

Exclusion

Exclusion Criteria:

  • History of recurrent urinary tract infection (2 or more culture-positive in 6 monthsor 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 gynecologicmalignancy

  • 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

Study Design

Total Participants: 34
Treatment Group(s): 3
Primary Treatment: Acupuncture
Phase:
Study Start date:
January 21, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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