| NCT ID | NCT06366269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Bladder Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-01-21 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
David Sheyn, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT06366269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Bladder Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06366269 currently recruiting?
Yes, NCT06366269 is actively recruiting participants. Contact the research team at Jessica.AbouZeki@UHhospitals.org for enrollment information.
Where is the NCT06366269 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06366269 clinical trial?
NCT06366269 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is David Sheyn, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 34 participants.