Investigation of PEMF Therapy for Female Patients With IC/BPS

Wake Forest University (WFU)

Status: Enrolling

Conditions: Chronic Interstitial Cystitis; Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Device: Sham Pulsed Electromagnetic Field (PEMF) Device; Device: Pulsed Electromagnetic Field (PEMF) Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05149573

IRB00079006

1R01DK128233-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.

Full 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 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).

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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75 participants in 3 patient groups

4-Week Treatment with no Maintenance Period

Active Comparator group

Description:

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.

Treatment:

Device: Pulsed Electromagnetic Field (PEMF) Device

4-Week Sham Treatment with no Maintenance Period

Sham Comparator group

Description:

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:

Device: Sham Pulsed Electromagnetic Field (PEMF) Device

4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months

Active Comparator group

Description:

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.

Treatment:

Device: Pulsed Electromagnetic Field (PEMF) Device