Recruiting

Acupuncture

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06366269

Conditions

Bladder Pain Syndrome

Interstitial Cystitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Behavioral management

Physical therapy

Study Details

Brief 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

Conditions

Bladder Pain Syndrome

Interstitial Cystitis

Study ID

NCT06366269

Start date

Jan 21, 2025

Status verified date

Jan, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acupuncture

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain.

They will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy.

active comparator: Behavioral Management

Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain for six (6) weeks before starting pelvic floor physical therapy.

Interventions

Acupuncture

traditional and electroacupuncture

Behavioral management

based on American urologic association guidelines

Physical therapy

pelvic floor with biofeedback

Primary outcome measure

  • O'Leary-Sant Interstitial Cystitis Index (OLSICI) [ Time Frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period) ]

Central Contacts and Locations

Central contacts

Jessica Abou Zeki

216-286-0603Jessica.AbouZeki@UHhospitals.org

Gabriella Rustia, MD

216-202-0597gabriella.rustia@uhhospitals.org

Locations

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gabriella Rustia, MD

216-202-0597gabriella.rustia@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • acupuncture
  • bladder pain syndrome
  • interstitial cystitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-01-08.