Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations
Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring interstitial cystitis, bladder pain syndrome, painful bladder, chronic pelvic pain, urinary urgency, urinary frequency, pulsed electromagnetic field, PEMF, bladder instillation
Eligibility Criteria
Inclusion Criteria: Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Current Numeric Rating Scale (NRS) greater than or equal to 5 History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia No contraindications to the instillation solution No cognitive deficits Exclusion Criteria: History of bladder, ovarian or vaginal cancer History of urethral diverticulum History of radiation cystitis History of spinal cord injury or spina bifida History of Parkinson's Disease History of Multiple Sclerosis (MS) History of Stroke History of genital herpes History of or current cyclophosphamide treatment Current placement of a pacemaker or metal prothesis Active urinary tract infection BMI >40 Residual urine of >100 cc Currently pregnant
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillations
6-week Sham Treatment with intravesical bupivacaine/heparin instillations
Participants will be instructed to self-administer pulsed electromagnetic field therapy (PEMF) devices immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. PEMF therapy will be self-administered using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat dry surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control B. Box) has been pre-programmed to deliver the same energy level every time. Participants will be instructed to administer this home treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the PEMF device is returned.
Participants will be provided with a sham B. Body and B. Pad that appears identical to the active pulsed electromagnetic field (PEMF) device. The participant will lie the sham B- Body mat on any flat dry surface and lay on the mat with with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. Participants will be instructed to administer this sham treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the sham PEMF device is returned.