Wake Forest University Health Sciences
The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.
IC/BPS is a chronic condition affecting the urinary bladder, causing generalized pelvic pain and urinary symptoms such as urgency, frequency, and nocturia. Although it is not a life-threatening condition, the chronicity and severity of pain, along with urinary symptoms, can negatively impact a patient's quality of life. IC/BPS poses as a significant clinical challenge for many reasons. Importantly, the pathophysiology is incompletely understood and likely multi-factorial, including factors such as inflammation, neurovascular dysfunction, ion imbalance, and impaired urothelial cell integrity. C…
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 S…
Pulsed Electromagnetic Field (PEMF) Device BEMER Device consist of a total body mat (B. BODY) plus a targeted pelvic mat (B.PAD), and a Control Unit which powers the device and logs usage. Both B.BODY and B.PAD must be plugged into the Control Unit simultaneously and activated individually. B. Body must be placed on a flat surface (i.e. bed, floor, reclining chair etc.) for best results.
The sham PEMF device appears identical to the BEMER PEMF device, with all of the same components and accessories, but does not emit a pulsed electromagnetic field.
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