PEMF Therapy for Interstitial Cystitis

Overseen By Stephen Walker, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Bladder instillations

Must not be taking: Cyclophosphamide

Disqualifiers: Cancer, Stroke, MS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Pulsed Electromagnetic Field (PEMF) therapy can reduce pain and symptoms for individuals with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) when combined with bladder treatments. Participants will use either the PEMF therapy or a sham (inactive) version following their prescribed bladder instillations of bupivacaine-heparin. The study will assess whether PEMF therapy provides more relief than the instillations alone. Women diagnosed with IC/BPS who experience significant daily pain might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore new treatment options for managing IC/BPS symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants will continue with bladder instillations of a bupivacaine-heparin cocktail, so you may need to continue those if you are already prescribed them.

What prior data suggests that this PEMF therapy is safe for IC/BPS patients?

Research has shown that Pulsed Electromagnetic Field (PEMF) therapy is generally safe. Studies indicate it is a non-invasive treatment, meaning it doesn't involve surgery or entering the body, and is well-tolerated. Evidence suggests that PEMF effectively reduces pain and improves symptoms for various conditions, including Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Significant reports of serious side effects linked to its use have not emerged. This suggests that PEMF therapy is a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for interstitial cystitis, which often involve oral medications, bladder instillations, or nerve stimulation, Pulsed Electromagnetic Field (PEMF) Therapy offers a new approach by using electromagnetic fields to potentially reduce pain and inflammation. Researchers are excited about PEMF because it provides a non-invasive treatment option that can be easily self-administered at home, potentially increasing patient compliance and comfort. This therapy targets the pelvic area directly through the use of a full-body mat and a targeted pelvic pad, delivering consistent energy levels to the affected area. Additionally, the incorporation of PEMF with traditional bladder instillations could enhance the overall therapeutic effect, offering hope for improved management of symptoms.

What evidence suggests that PEMF therapy could be an effective treatment for Interstitial Cystitis?

Research has shown that Pulsed Electromagnetic Field (PEMF) therapy can greatly reduce pelvic pain. In one study, 87.5% of participants reported a noticeable decrease in pain after treatment. These participants also experienced improved overall symptoms and quality of life. Other studies support PEMF's positive effects on pain and symptom relief. In this trial, one group of participants will receive PEMF therapy, while another group will receive a sham treatment. This suggests that PEMF therapy might be a good option for managing symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). ^{1 2 6 7 8}

Who Is on the Research Team?

Stephen Walker, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adult women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who experience significant pain (NRS ≥ 5). They must have had a cystoscopy with bladder capacity measurement and no cognitive deficits. Exclusions include a history of certain cancers, urinary conditions, neurological disorders, pregnancy, pacemaker or metal prosthesis presence, active infections, or extreme obesity (BMI >40).

Inclusion Criteria

No cognitive deficits

I have no allergies or reactions to the treatment solution.

I have been diagnosed with Interstitial Cystitis or Bladder Pain Syndrome.

Exclusion Criteria

I have had a spinal cord injury or spina bifida.

I have been diagnosed with Parkinson's Disease.

You have a pacemaker or metal implant in your body right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6 weeks

3 visits per week (self-administered)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Electromagnetic Field (PEMF) Therapy

Trial Overview

The study tests if Pulsed Electromagnetic Field (PEMF) therapy combined with bladder instillations of bupivacaine-heparin can better reduce chronic pain and symptoms in IC/BPS patients than the instillation alone. Participants will receive either PEMF therapy or a sham device alongside their prescribed treatment.

How Is the Trial Designed?

Group I: 6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillations Active Control 1 Intervention

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.

Group II: 6-week Sham Treatment with intravesical bupivacaine/heparin instillations Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Pulsed electromagnetic field (PEMF) therapy is a non-invasive treatment that has shown significant efficacy in reducing pain for various chronic pain conditions, suggesting it may also benefit patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Randomized, double-blinded, placebo-controlled trials have demonstrated positive safety and efficacy profiles for PEMF in treating conditions like low back pain and fibromyalgia, indicating its potential as a therapeutic option for managing chronic pain and fatigue in IC/BPS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic field (PEMF) as an adjunct therapy for pain management in interstitial cystitis/bladder pain syndrome. Ross, C., Overholt, T., Xu, R., et al.[2022]

Pulsed electromagnetic field therapy is a noninvasive treatment that may effectively reduce pelvic pain and other symptoms associated with interstitial cystitis/bladder pain syndrome, as demonstrated in a case study.

This therapy offers a safer alternative to aggressive management options like opioids and surgery, suggesting the need for further clinical trials to evaluate its efficacy in chronic pelvic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Field Therapy as a Complementary Alternative for Chronic Pelvic Pain Management in an Interstitial Cystitis/Bladder Pain Syndrome Patient. Overholt, TL., Ross, C., Evans, RJ., et al.[2020]

Pulsed electromagnetic field (PEMF) therapy has been shown to effectively manage postsurgical pain and edema, as well as promote healing in chronic wounds, making it a valuable tool in plastic surgery.

PEMF therapy is noninvasive and has no known side effects, providing a safe adjunctive treatment option for postoperative recovery, supported by scientific evidence of its mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Strauch, B., Herman, C., Dabb, R., et al.[2022]

In a study involving 10 women with non-bladder centric interstitial cystitis/bladder pain syndrome, 87.5% experienced a significant reduction in pelvic pain after 4 weeks of pulsed electromagnetic field (PEMF) therapy, indicating its efficacy as a treatment option.

No adverse events were reported during the study, suggesting that PEMF therapy is a safe alternative for managing chronic bladder pain, although further comparative trials are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Field Therapy for Pain Management in Interstitial Cystitis/Bladder Pain Syndrome: A Proof-of-Concept Case Series. Wolff, DT., Ross, C., Lee, P., et al.[2022]

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