PEMF Therapy for Bladder Infection

Overseen By Stephen Walker, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cancer, Spinal injury, Stroke, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-drug, non-invasive treatment called pulsed electromagnetic field (PEMF) therapy to determine its effectiveness in reducing bladder and pelvic pain for women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Participants will use a PEMF device at home, lying on a mat and placing a pad over the pelvic area twice a day for 8-minute sessions. Some will receive additional maintenance treatments. Women diagnosed with IC/BPS and experiencing bothersome bladder symptoms might be suitable for this study. As an unphased trial, this study offers participants the chance to explore a novel treatment option that could potentially alleviate their symptoms.

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 prior data suggests that this PEMF device is safe for treating bladder infections?

Research has shown that pulsed electromagnetic field (PEMF) therapy is generally safe. Studies have found that PEMF is well-tolerated and can help reduce symptoms in conditions like urinary incontinence and bladder pain. These studies have reported no major side effects, suggesting the treatment is quite safe.

One study specifically highlighted PEMF as a non-invasive and effective therapy for interstitial cystitis (also known as bladder pain syndrome), which is similar to the condition under study in this trial. People have used PEMF without major side effects, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulsed electromagnetic field (PEMF) therapy for bladder infections because it offers a non-invasive approach, unlike traditional antibiotics. Most treatments for bladder infections rely on antibiotics to kill bacteria, but PEMF therapy aims to reduce inflammation and improve blood flow to the pelvic area, potentially accelerating healing. This method uses a B. Body mat and B. Pad to deliver targeted electromagnetic pulses, which is a novel delivery system compared to pills or injections. Additionally, PEMF therapy could be a promising option for those who cannot take antibiotics or who suffer from recurrent infections.

What evidence suggests that PEMF therapy is effective for bladder infection?

Research has shown that pulsed electromagnetic field (PEMF) therapy, which participants in this trial may receive, can help reduce symptoms in people with urinary problems. In earlier studies, patients using PEMF reported significant relief from symptoms of urinary incontinence, similar to those experienced with interstitial cystitis (IC) and bladder pain syndrome (BPS). Another study found that PEMF therapy effectively managed mixed incontinence when combined with pelvic floor exercises. These findings suggest that PEMF therapy could help reduce pelvic pain and urinary symptoms linked to IC/BPS. The therapy is generally safe and well-tolerated. ^{1 2 3 4 6}

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1. imrpress.com imrpress.com/journal/CEOG/49/4/10.31083/j.ceog4904091/htm

Impact of pulsed electromagnetic field on mixed ... PEMF combined with pelvic floor muscle training is an effective, convenient, and acceptable way to manage mixed incontinence.

2. journals.lww.com journals.lww.com/ursc/fulltext/2022/33040/efficacy_and_safety_of_pulsed_electromagnetic.3.aspx

Efficacy and Safety of Pulsed Electromagnetic Field (PEMF)... The PEMF stimulation is a safe and effective approach for reducing the symptoms of patients with UI. The best response to treatment was reported at 6 months ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084708/

Chronic E. Coli Drug-Resistant Cystitis Treated with a ... This study investigated the effects of sequenced electromagnetic fields, modulated at extremely low frequencies and intensities, in the treatment of drug- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04540887

PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain ... The purpose of this study will be to determine if PEMF therapy in patients with IC/BPS is an effective treatment in reducing pelvic pain. Official Title.

5. researchgate.net researchgate.net/publication/365904974_Efficacy_and_Safety_of_Pulsed_Electromagnetic_Field_PEMF_Stimulation_in_the_Treatment_of_Urinary_Symptoms_in_Women_with_Urinary_Incontinence

Efficacy and Safety of Pulsed Electromagnetic Field (PEMF ... Efficacy and Safety of Pulsed Electromagnetic Field (PEMF) Stimulation in the Treatment of Urinary Symptoms in Women with Urinary Incontinence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4145661/

Effect of Pulsed Electromagnetic Field Therapy on Prostate ... We studied the efficacy of pulsed electromagnetic field therapy (PEMF) in dogs to modify prostate blood flow and evaluated its effect on BPH.