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
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 34 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Jan 2025 (actual). Primary completion is estimated for Oct 2026, 21 months after the start.
Of 35 non-industry interventional studies with no phase under Cystitis, Interstitial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 34. This study's planned 21 months is close to that.
Counting every sponsor, half of 39 studies reached it within 23 months; a quarter within 16 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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University Hospitals Cleveland Medical Center →