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NCT Number: NCT06366269

Acupuncture First for IC/BPS

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

Recruiting

Interested in participating?

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Key information

Conditions

Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Interstitial Cystitis Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Gabriella Rustia, MD

CONTACT

[email protected]

216-202-0597

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

traditional and electroacupuncture

Behavioral Management

Behavioral

based on American urologic association guidelines

Physical Therapy

Other

pelvic floor with biofeedback

Primary outcomes

  1. 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)

    Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms.

Secondary outcomes

  1. Patient Global Impression of Improvement (PGI-I)

    Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)

    Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse).

  2. Short Form (SF-36)

    Time frame: x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)

    Validated 36-item questionnaire. Higher scores are consistent with worse symptom control.

  3. Genitourinary Pain Index (GUPI)

    Time frame: Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)

    Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control.

  4. Number of additional treatments used during study period

    Time frame: 1 year post-treatment period

    Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine

  5. Number of unscheduled interactions

    Time frame: 1 year post-treatment period

    Unscheduled interactions include any phone calls, messages, or unplanned visits

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Rustia, MD

CONTACT

[email protected]

216-202-0597

Jessica Abou Zeki

CONTACT

[email protected]

216-286-0603

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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