Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2025-01-21
2026-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Acupuncture
traditional and electroacupuncture
Behavioral management
based on American urologic association guidelines
Physical therapy
pelvic floor with biofeedback
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 management
based on American urologic association guidelines
Physical therapy
pelvic floor with biofeedback
Interventions
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Acupuncture
traditional and electroacupuncture
Behavioral management
based on American urologic association guidelines
Physical therapy
pelvic floor with biofeedback
Eligibility Criteria
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Inclusion Criteria
* Negative urine culture
* Has completed cystoscopic evaluation for IC/BPS
Exclusion Criteria
* 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
18 Years
89 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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David Sheyn
Physician, UHMG
Principal Investigators
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David Sheyn, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20240374
Identifier Type: -
Identifier Source: org_study_id
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