Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) - PROJECT SUMMARY
The goal of this pilot and feasibility clinical trial is to acquire preliminary data regarding the safety and efficacy
of the non-invasive pulsed electromagnetic field (PEMF) therapy for pain management in interstitial
cystitis/bladder pain syndrome (IC/BPS) patients. We present preliminary data suggesting that IC/BPS
comprises at least two distinct phenotypic subpopulations; one characterized as a bladder-centric disease
process and the other characterized as a non-bladder-centric systemic pain syndrome. We propose to leverage
our large patient database to recruit patients into this clinical trial wherein we will test the safety and efficacy of
PEMF therapy. The trial will employ a single-site, randomized, double-blind, sham placebo-controlled study
design. To accomplish the goals of this clinical trial, we propose the following three Specific Aims.
Specific Aim 1: Determine the impact of PEMF therapy on pain reduction in IC/BPS patients. From our
registry of 488 IC/BPS patients we will recruit 60 adult female patients who have met all inclusion/exclusion
criteria, that includes: (1) 30 patients with an anesthetic BC≤400 anesthetic (i.e., bladder centric phenotype), and
(2) 30 patients with an anesthetic BC>400 cc (i.e., those with a non-bladder centric (systemic) phenotype); all
having a current numeric rating scale (NRS) pain score of ≥6. Patients within each of the two phenotypic groups
will be randomly assigned (1:1 ratio) to either the PEMF treatment or sham group, trained in the clinic on the use
of the PEMF device, and then undergo twice daily PEMF therapy (or sham) sessions at home for four weeks.
The sham device is identical in every way to the treatment devices except it does not deliver a pulsed
electromagnetic field. Patients will be assessed at enrollment, at follow-up after the 4-week treatment period,
and then monthly for the next 3 months. The primary outcome measure will be a significant change in their pelvic
pain score (i.e., a decrease ≥ 2). Secondary outcomes will be assessed by validated IC/BPS questionnaires
(O’Leary-Sant), voiding characteristics (voiding diary), Brief Pain Inventory (BPI) Short Form, Pelvic Pain and
Urgency/Frequency (PUF) Patient Symptom Scale, and Global Response Assessment (GRA).
Specific Aim 2: Determine the duration of benefit from PEMF therapy with and without maintenance
treatments. An additional cohort of 15 adult female patients with non-bladder centric IC/BPS will be recruited
and undergo the standard 4-week regimen, followed by a one-week-per-month of twice daily PEMF therapy
regimen for an additional 3 months. Primary and secondary outcomes will be assessed monthly, out to 4 months,
as described in Aim 1. The results will be compared to the non-bladder centric patients treated for 4 weeks only
in Aim 1. If results from Aim 1 show that there is no difference in the positive response between the two groups,
or that PEMF therapy benefits bladder-centric patients more than non-bladder centric patients, then the patient
make-up for Aim 2 will be adjusted accordingly (i.e., 8 patients from each group (N=16), or all 15 will be bladder-
centric, respectively) and the comparator group(s) will be adjusted accordingly.
