Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

Wake Forest University (WFU)

Status: Begins enrollment in 7 months

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06013449

IRB00100535

Details and patient eligibility

About

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.

Full description

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. Consequently, there are many therapeutic options for IC/BPS, 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 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 anesthetic bladder capacity (BC), in which patients with BC ≤ 500 cc are more likely to experience severe pain, urgency and frequency (bladder centric sub-phenotype), and patients with BC > 500 cc (non-bladder centric sub-phenotype) have a higher prevalence of non-urological associated syndromes (NUAS) such as fibromyalgia, migraines, chronic fatigue symptoms, irritable bowel syndrome, endometriosis and sicca syndrome.

Intravesical bladder instillations have been listed as a treatment option for IC/BPS by the American Urologic Association (AUA). Current evidence supports the use of single or multi-dose regimens of Dimethyl sulfoxide (DMSO), heparin and/or lidocaine. Heparin is a sulfated polysaccharide that is theorized to help restore the bladder's glycosaminoglycan (GAG) layer upon instillation, and multiple studies have demonstrated its effectiveness as an intravesical agent for symptom control. The combination of heparin with local anesthetics such as lidocaine/bupivacaine has been shown to provide even greater symptom relief than heparin alone.

Pulsed Electromagnetic Field (PEMF) therapy is a safe, non-invasive, and effective treatment option currently used for enhanced wound healing, bone-related diseases (osteoarthritis, Rheumatoid arthritis (RA)), and chronic pain states (chronic lower back pain, fibromyalgia), the latter of which is frequently associated with IC/BPS. The proposed mechanism(s) of action of PEMF therapy have 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

PEMF therapy in conjunction with intravesical instillations of heparin and lidocaine/bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone. Due to PEMF's proposed mechanism of action of improving microcirculation and tissue regenerative capacity, it may be able to augment pain reduction by improving both the protective effect of heparin on the GAG layer and bupivacaine's anesthetic efficacy. Using a randomized, sham-controlled trial design, this study will investigate the potential added therapeutic benefit of simultaneous PEMF therapy in patients who self-administer bladder instillations of heparin-bupivacaine multiple times per week, compared to instillations administered without PEMF.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 Sclerosis (MS)
• History of Stroke
• History of genital herpes
• History of or current cyclophosphamide treatment
• Current placement of a pacemaker or metal prothesis
• Active urinary tract infection
• BMI >40
• Residual urine of >100 cc
• Currently pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillations

Active Comparator group

Description:

Participants will be instructed to self-administer pulsed electromagnetic field therapy (PEMF) devices immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. PEMF therapy will be self-administered using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat dry surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control B. Box) has been pre-programmed to deliver the same energy level every time. Participants will be instructed to administer this home treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the PEMF device is returned.

Treatment:

Device: Pulsed Electromagnetic Field (PEMF) Device

6-week Sham Treatment with intravesical bupivacaine/heparin instillations

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 dry surface and lay on the mat with with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. Participants will be instructed to administer this sham treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the sham PEMF device is returned.

Treatment:

Device: Sham Pulsed Electromagnetic Feild (PEMF) Device