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
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
Exclusion Criteria:
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
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
traditional and electroacupuncture
based on American urologic association guidelines
pelvic floor with biofeedback
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)
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)
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)
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)
Number of additional treatments used during study period
Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine
Time frame: 1 year post-treatment period
Number of unscheduled interactions
Unscheduled interactions include any phone calls, messages, or unplanned visits
Time frame: 1 year post-treatment period
Plan to share: No
No publications or documents are linked to this record.
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University Hospitals Cleveland Medical Center