Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Keywords
acupuncture, bladder pain syndrome, interstitial cystitis
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
Interventions
OTHERAcupuncture
traditional and electroacupuncture
BEHAVIORALBehavioral management
based on American urologic association guidelines
OTHERPhysical therapy
pelvic floor with biofeedback
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| O'Leary-Sant Interstitial Cystitis Index (OLSICI) | Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period) | Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) | x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period) | Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse). |
| Short Form (SF-36) | x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period) | Validated 36-item questionnaire. Higher scores are consistent with worse symptom control. |
| Genitourinary Pain Index (GUPI) | Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period) | Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control. |
| Number of additional treatments used during study period | 1 year post-treatment period | Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine |
| Number of unscheduled interactions | 1 year post-treatment period | Unscheduled interactions include any phone calls, messages, or unplanned visits |
Countries
United States
Contacts
Primary ContactJessica Abou Zeki
Backup ContactGabriella Rustia, MD
Outcome results
None listed