PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome
Condition: Interstitial Cystitis; Chronic Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to gather information from the investigation of a
      non-pharmacological (non-drug) treatment known as low frequency pulsed electromagnetic field
      (PEMF). The study team will be distributing the PEMF therapy to female subjects with
      Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease
      pelvic pain. The results, from multiple questionnaires and voiding diaries, will be compared
      when participants are enrolled for treatment, at 4 weeks after using PEMF therapy, and 12
      weeks post-enrollment.
    

Detailed description: 
      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 identified
      cause for the symptoms. Although it is not a life-threatening disease, the chronicity and
      severity of pain, along with urinary symptoms, causes great impairment in a patient's quality
      of life. IC/BPS poses as 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
      IC/BPS. PEMF is a safe, non-invasive, and effective therapy currently used for wound healing,
      bone-related diseases (osteoarthritis, RA), and chronic pain states (chronic lower back pain,
      fibromyalgia), the latter of which is 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 will be to determine if PEMF therapy
      in patients with IC/BPS is an effective treatment in reducing pelvic pain.
    

Intervention name(s): Pulsed Electromagnetic Field (PEMF) Therapy
Intervention type(s): Device
Intervention description(s): PEMF therapy will be self-administered by all trial participants using the B. Body, B. Pad, and Control Unit. Participants will administer this therapy twice a day (morning and evening) for 8-minute sessions over a four week period.
Other intervention name(s): BEMER B. Body; BEMER B. Pad; BEMER Control Unit
Intervention model: Single Group Assignment
Intervention model description: This is a single center clinical series evaluating symptom relief following a 4-week trial of PEMF therapy. From our registry of IC/BPS patients at Wake Forest Baptist Health Urology we will recruit women, ages 18-80, who have met all inclusion and exclusion criteria. Upon enrollment, each participant will be taught how to administer home treatment with the Bio Electro Magnetic Energy Regulation (BEMER) PEMF devices which consist of a total body mat (B.Body) plus a targeted pelvic mat (B.Pad) and control unit. Following the brief in-clinic training, participants will be sent home with the PEMF devices (preset to deliver the same level of energy every time) and self-administer therapy sessions, twice daily (once in the morning, once in the evening) for 8 minutes at a time. Participants will complete questionnaires as well as keep a 3-day voiding diary to record any changes in IC/BPS symptoms/pain at enrollment, 4 weeks after using PEMF therapy, and 12 weeks post-enrollment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interstitial Cystitis; Bladder Pain Syndrome; Painful Bladder Syndrome; IC; BPS; Painful Bladder; Urinary urgency; Urinary frequency; Nocturia; Urinary incontinence