Clinical trial NCT05149573: Investigation of PEMF Therapy for Female Patients With IC/BPS
Official title: Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interstitial Cystitis
Chronic Interstitial Cystitis
Bladder Pain Syndrome
Keywords: interstitial cystitis
bladder pain syndrome
painful bladder syndrome
painful bladder
bladder pain
urinary urgency
urinary frequency
pulsed electromagnetic field
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-08
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study is designed as a double-blind, sham-controlled clinical trial separated into two Aims. Aim 1 will include 60 female adults with IC/BPS, divided into two groups: 1) 30 participants with an anesthetic bladder capacity (BC) ≤ 400cc and 2) 30 participants with BC \> 400cc. Patients within each of the two groups will be randomly assigned in a 1:1 ratio to either the PEMF (treatment) or Sham (control) group. The Sham device is identical to the treatment device but does not deliver PEMF. All participants will be instructed to use their device every day, morning and evening, for 8-minute sessions over a 4-week period.

Aim 2 will include an additional cohort of 15 female adults with IC/BPS. These participants will undergo the standard 4-week regimen of PEMF therapy, followed by a one-week-per-month maintenance period of twice daily PEMF therapy for an additional 3 months post-enrollment (the fourth week in months 2, 3, and 4).
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

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

Primary outcomes:
measure: Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Baseline
measure: Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Week 4
measure: Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Week 8
measure: Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Week 12
measure: Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Week 16
Secondary outcomes:
measure: 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)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by the Global Response Assessment (GRA)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change in Urinary symptoms, as measured by 3-day voiding diaries
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen J Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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