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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Pulsed Electromagnetic Field (PEMF) Therapy for Interstitial Cystitis?

Research suggests that Pulsed Electromagnetic Field (PEMF) Therapy, which is non-invasive, may help reduce pain and inflammation in conditions like interstitial cystitis, as it has shown benefits in managing other chronic pain conditions such as fibromyalgia and chronic low back pain. ^{1 2 3 4 5}

Is PEMF therapy safe for humans?

PEMF therapy is considered safe for managing pain in conditions like osteoarthritis and has been used without major safety concerns in other chronic pain conditions. ^{1 2 3 6 7}

How does PEMF therapy differ from other treatments for interstitial cystitis?

PEMF therapy is unique because it is a non-invasive treatment that uses electromagnetic fields to reduce pain and inflammation, unlike other treatments that may involve medications or surgery. It has shown promise in managing pain for other chronic conditions, making it a novel option for interstitial cystitis, which often lacks effective standard treatments. ^{1 2 3 7 8}

What is the purpose of this trial?

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.

Research Team

Stephen Walker, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Field Therapy for Pain Management in Interstitial Cystitis/Bladder Pain Syndrome: A Proof-of-Concept Case Series. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic field (PEMF) as an adjunct therapy for pain management in interstitial cystitis/bladder pain syndrome. [2022]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Does sacral pulsed electromagnetic field therapy have a better effect than transcutaneous electrical nerve stimulation in patients with neurogenic overactive bladder? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of pulsed electromagnetic fields on human osteoblastlike cells (MG-63): a pilot study. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Osteogenic differentiation of amniotic epithelial cells: synergism of pulsed electromagnetic field and biochemical stimuli. [2022]