NCT06013449

Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

Investigation of the Effect of Simultaneous Pulsed Electromagnetic Field (PEMF) and Intravesical Heparin - Bupivacaine Cocktail Instillation for the Symptomatic Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Interstitial Cystitis
• Chronic Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DEVICE	Pulsed Electromagnetic Field (PEMF) Device	Pulsed Electromagnetic Field (PEMF) Device BEMER Device consist of a total body mat (B. BODY) plus a targeted pelvic mat (B.PAD), and a Control Unit which powers the device and logs usage. Both B.BODY and B.PAD must be plugged into the Control Unit simultaneously and activated individually. B. Body must be placed on a flat surface (i.e. bed, floor, reclining chair etc.) for best results.
DEVICE	Sham Pulsed Electromagnetic Feild (PEMF) Device	The sham PEMF device appears identical to the BEMER PEMF device, with all of the same components and accessories, but does not emit a pulsed electromagnetic field.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2023-08-28
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study