Investigation of PEMF Therapy for Female Patients With IC/BPS

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a clinical diagnosis based primarily on chronic symptoms of pain perceived by the patient to emanate from the bladder and/or pelvis associated with urinary urgency or frequency in the absence of another identifiable cause of the symptoms. Although it is not a life-threatening disease, the chronicity and severity of pain, along with other urinary symptoms, causes great impairment in a patient's quality of life. In addition, IC/BPS poses a significant clinical challenge for many reasons. For one, the pathophysiology described in the literature is incompletely determined and likely multi-factorial, including factors such as inflammation, neurovascular dysfunction, ion imbalance, and impaired urothelial cell integrity. Consequently, there are many options for IC/BPS therapy, many of which are driven primarily by patient-reported symptoms. In this regard, IC/BPS patients with moderate to severe pain typically require multi-modal therapy, often resulting in incomplete or no resolution of symptoms. Another clinical challenge is the heterogeneity of the symptoms. While pelvic pain is the distinguishing characteristic, patients with IC/BPS also routinely present with additional urological and non-urological medical symptoms and syndromes. This has led to the description of two specific sub-phenotypes in IC/BPS based on anesthetized bladder capacity (BC), in which patients with BC \< 400 cc are more likely to experience severe pain, urgency and frequency (bladder centric sub-phenotype), and patients with BC \> 400 cc (non-bladder centric sub-phenotype) have a higher prevalence of non-urological associated syndromes (NUAS) such as fibromyalgia, chronic fatigue symptoms, irritable bowel syndrome, endometriosis and sicca syndrome.

Pulsed Electromagnetic Field (PEMF) therapy may present a promising alternative therapy for patients with IC/BPS. PEMF is a safe, non-invasive, and effective therapy currently used for wound healing, bone-related diseases (osteoarthritis, rheumatoid arthritis), and chronic pain states (chronic lower back pain, fibromyalgia), the latter of which are frequently associated with IC/BPS as NUAS. Based on Faraday's law, electromagnetic interactions (e.g. PEMF) with biological processes and conditions (e.g. IC/BPS) will theoretically address many of the proposed pathophysiological causes of the condition. While the mechanism(s) of action are not fully understood, PEMF therapy has been shown in several studies (randomized, double-blinded, placebo-controlled trials) to decrease the output of pro-inflammatory proteins, improve oxygenation of blood and tissue, stabilize transmembrane action potential and ion channels, and stimulate tissue regeneration. Thus, PEMF may provide a safe, non-invasive therapeutic option that would be complementary to, or serve as an alternative for, the treatments that are currently being administered in IC/BPS for pain reduction. Of note, PEMF has demonstrated an excellent safety profile with no associated systemic risks reported to date. Additionally, the application of exogenous PEMF to stimulate the pelvic floor muscle has recently been introduced for treating urge and/or stress urinary incontinence and overactive bladder. Furthermore, if patient safety and efficacy for pain reduction are demonstrated, these feasibility studies will provide the foundation for larger multi-site trials to determine additional parameters regarding the appropriate number of treatments as well as the duration of benefit (pain relief) following treatments.

The purpose of this study is to determine the safety and efficacy of PEMF therapy to significantly reduce pain among female patients with IC/BPS (Aim 1) and to evaluate the duration of benefit from PEMF therapy with and without maintenance treatments over a 4-month period (Aim 2).

• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by O'Leary Sant Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI) [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16]
• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16]
• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by the Global Response Assessment (GRA) [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16]
• Change in Urinary symptoms, as measured by 3-day voiding diaries [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16]