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.
