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RecruitingNCT06366269Updated Jan 8, 2026

Acupuncture First for IC/BPS

An interventional study of Acupuncture and Behavioral management in Bladder Pain Syndrome and Interstitial Cystitis, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

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
02

Conditions studied

  • Bladder Pain Syndrome
  • Interstitial Cystitis

Keywords

  • acupuncture
  • bladder pain syndrome
  • interstitial cystitis
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
34 participants (estimated)

Study 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.

    Other: Acupuncture · Behavioral: Behavioral management · Other: 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.

    Behavioral: Behavioral management · Other: Physical therapy

Interventions

  • OtherAcupuncture

    traditional and electroacupuncture

  • BehavioralBehavioral management

    based on American urologic association guidelines

  • OtherPhysical therapy

    pelvic floor with biofeedback

05

What researchers measure

Primary outcomes

  1. O'Leary-Sant Interstitial Cystitis Index (OLSICI)

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

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

Secondary outcomes

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

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

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

  2. Short Form (SF-36)

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

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

  3. Genitourinary Pain Index (GUPI)

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

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

  4. Number of additional treatments used during study period

    Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine

    Time frame: 1 year post-treatment period

  5. Number of unscheduled interactions

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

    Time frame: 1 year post-treatment period

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06366269
Lead sponsor
University Hospitals Cleveland Medical Center
Responsible party
David Sheyn (Physician, UHMG, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Apr 15, 2024
Start date
Jan 21, 2025
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 8, 2026

Study contacts

Jessica Abou Zeki
Contact
Jessica.AbouZeki@UHhospitals.org
216-286-0603
Gabriella Rustia, MD
Contact
gabriella.rustia@uhhospitals.org
216-202-0597
David Sheyn, MD
principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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