Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
|
| Behavioral Management | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | traditional and electroacupuncture |
| |
| Behavioral management |
| Measure | Description | Time Frame |
|---|---|---|
| O'Leary-Sant Interstitial Cystitis Index (OLSICI) | Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms. | Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period) |
| Short Form (SF-36) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Abou Zeki | Contact | 216-286-0603 | Jessica.AbouZeki@UHhospitals.org | |
| Gabriella Rustia, MD | Contact | 216-202-0597 | gabriella.rustia@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| David Sheyn, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals | Recruiting | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.
| Behavioral |
based on American urologic association guidelines |
|
| Physical therapy | Other | pelvic floor with biofeedback |
|
Validated 36-item questionnaire. Higher scores are consistent with worse symptom control. |
| 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. | 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 | 1 year post-treatment period |
| Number of unscheduled interactions | Unscheduled interactions include any phone calls, messages, or unplanned visits | 1 year post-treatment period |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |