PEMF Therapy for Bladder Infection

Overseen by Stephen Walker, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cancer, Spinal injury, Stroke, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a non-drug treatment called PEMF therapy on women with chronic bladder and pelvic pain. The therapy uses electromagnetic fields to reduce pain and improve symptoms. Researchers aim to see if it is safe and effective over several months. Pulsed electromagnetic field (PEMF) therapy has been shown to reduce tissue inflammation and improve symptoms in conditions like benign prostatic hyperplasia (BPH).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Since the study focuses on a non-drug treatment, it's possible that you may not need to stop, but you should confirm with the study team.

What data supports the effectiveness of the treatment for bladder infection?

Research suggests that pulsed electromagnetic field (PEMF) therapy can help reduce pain in conditions like interstitial cystitis/bladder pain syndrome, which involves chronic pelvic pain. This indicates that PEMF therapy might also be beneficial for managing pain associated with bladder infections. ^{1 2 3 4 5}

How is PEMF therapy different from other treatments for bladder infections?

PEMF therapy is unique because it is a non-invasive treatment that uses electromagnetic fields to reduce pain and inflammation, unlike traditional treatments that may involve medications or surgery. It has shown promise in managing chronic pain conditions like interstitial cystitis/bladder pain syndrome, offering a potential alternative for those seeking less aggressive options. ^{1 3 4 5 6}

Research Team

Stephen Walker, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adult women with a painful bladder condition called Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Participants must have significant pain, as shown by a score of 6 or more on the pain scale, and have had specific bladder tests. Women can't join if they've had certain cancers, neurological diseases like Parkinson's or MS, a pacemaker or metal implants, are very overweight (BMI > 40), currently pregnant, or have some other urinary conditions.

Inclusion Criteria

Your pain level is currently 6 or higher on a scale of 0 to 10.

I have had a bladder examination under anesthesia to measure its capacity.

You do not have problems with your memory or thinking.

Exclusion Criteria

I have had a urethral diverticulum.

I have a history of Parkinson's disease, multiple sclerosis, or stroke.

I have had bladder inflammation due to radiation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PEMF therapy or sham treatment for 4 weeks, administered twice daily for 8-minute sessions

4 weeks

Home-based treatment

Maintenance

Participants in the active comparator group continue with 1-week-per-month maintenance PEMF therapy for 3 months

3 months

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 4, 8, 12, and 16 weeks post-enrollment

12 weeks

Electronic questionnaires

Treatment Details

Interventions

• Pulsed Electromagnetic Field (PEMF) Device (Electromagnetic Therapy)
• Sham Pulsed Electromagnetic Field (PEMF) Device (Sham Device)

Trial Overview The study is testing PEMF therapy—a non-drug treatment using magnetic fields—to see if it helps reduce bladder and pelvic pain in IC/BPS. Women will use either the real PEMF device or a sham (fake) device to compare results over time at different intervals up to 16 weeks after starting treatment.

Participant Groups

Group I: 4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months Active Control 1 Intervention

Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will keep the device and use it for 1 week (7 days) during the last week of the month for the following 3 months. Each participant in this group will be asked to complete a set of electronic questionnaires immediately following their week-long maintenance treatment during the last 3 months of the study.

Group II: 4-Week Treatment with no Maintenance Period Active Control 1 Intervention

Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.

Group III: 4-Week Sham Treatment with no Maintenance Period 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 surface and lay on the mat with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the sham device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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 energy therapy is a treatment method that uses electromagnetic fields to promote healing, which was applied to an 85-year-old woman with a sacral pressure sore.

The therapy aims to enhance tissue repair and reduce inflammation, demonstrating potential benefits in wound healing for elderly patients with pressure sores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating a pressure sore with PEME. Buswell, W.[2019]

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]

Long-term exposure to pulsed electromagnetic fields (PEMF) at 10 and 20 mT for 10 weeks in male rats resulted in increased liver enzymes, indicating potential liver damage.

The study found decreased antioxidant enzyme activities and immunoglobulin levels, suggesting that PEMF exposure may lead to oxidative stress and impaired immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-term pulsed electromagnetic field exposure on hepatic and immunologic functions of rats. Li, BL., Li, W., Bi, JQ., et al.[2018]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Treating a pressure sore with PEME. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Austria pubmed.ncbi.nlm.nih.gov

Effect of long-term pulsed electromagnetic field exposure on hepatic and immunologic functions of rats. [2018]

5. 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]

6. 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]