Investigation of PEMF Therapy for Female Patients With IC/BPS
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 syndrome, painful bladder, bladder pain, urinary urgency, urinary frequency, pulsed electromagnetic field
Eligibility Criteria
Inclusion Criteria:
- Previously established clinical diagnosis of IC/PS
- Current numeric rating scale (NRS) score of ≥ 6
- History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia
- No cognitive deficits
Exclusion Criteria:
- History of bladder, ovarian, vaginal cancer
- History of urethral diverticulum
- History of radiation cystitis
- History of spinal cord injury or spina bifida
- History of Parkinson's disease, multiple sclerosis, or stroke
- Current placement of a pacemaker or metal prosthesis
- Active urinary tract infection
- BMI > 40
- Residual urine of > 100cc
- Current pregnant
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
Active Comparator
4-Week Treatment with no Maintenance Period
4-Week Sham Treatment with no Maintenance Period
4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months
Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.
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 surface and lay on the mat with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the sham device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.
Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will keep the device and use it for 1 week (7 days) during the last week of the month for the following 3 months. Each participant in this group will be asked to complete a set of electronic questionnaires immediately following their week-long maintenance treatment during the last 3 months of the study.