What side effects are associated with this type of intervention?

Common treatments for Interstitial Cystitis (IC) include non-pharmacological approaches like Low-Frequency Pulsed Electromagnetic Field (PEMF) Therapy, which aims to reduce inflammation and modulate cellular activity. Side effects for PEMF therapy are generally minimal but can include mild discomfort or skin irritation at the application site. Physical therapy, particularly myofascial release, may cause temporary soreness or discomfort. Intravesical therapies, such as the use of pentosan polysulfate sodium, can lead to bladder irritation, gastrointestinal issues, and hair loss. Dietary modifications are typically safe but may require significant lifestyle adjustments. Overall, these treatments are considered relatively safe with manageable side effects.

What prior FDA approvals exist?

Pentosan polysulfate sodium (PPS) is the only oral medication approved by the FDA for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). PPS is believed to work by reconstituting the protective glycosaminoglycan layer over the urothelium, thereby reducing inflammation and pain. While not directly similar to PEMF therapy, which modulates cellular activity and reduces inflammation through electromagnetic fields, both treatments aim to alleviate symptoms by addressing underlying inflammatory processes.

What other types of research exist?

Promising novel alternatives to Low-Frequency Pulsed Electromagnetic Field (PEMF) Therapy for Interstitial Cystitis patients include: 1) Cyclosporine A (CyA) therapy, particularly for patients with Hunner lesions, which has shown significant symptom improvement. 2) Acupuncture, which has demonstrated efficacy in reducing pain and urinary symptoms in clinical trials. 3) Cognitive Behavioral Therapy (CBT) and other psychological interventions, which can help manage chronic pain and improve quality of life. 4) Physical therapy focused on pelvic floor dysfunction, which can alleviate pain and improve bladder function. These alternatives offer various mechanisms of action, including immunomodulation, pain relief, and psychological support, making them viable options for IC patients.

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Electromagnetic Therapy

PEMF Therapy for Bladder Infection

N/A

Recruiting

Led By Stephen J Walker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia

Previously established clinical diagnosis of IC/PS

Must not have

History of urethral diverticulum

History of Parkinson's disease, multiple sclerosis, or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 8, week 12, and week 16

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since PEMF therapy is non-invasive and doesn't involve drugs, side effects are expected to be minimal. However, there might be unforeseen reactions due to individual sensitivity to electromagnetic fields.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with interstitial cystitis/painful bladder syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a urethral diverticulum.

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

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I have a history of bladder, ovarian, or vaginal cancer.

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I have had bladder inflammation due to radiation.

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I have had a spinal cord injury or spina bifida.

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I currently have a urinary tract infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

Secondary study objectives

Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by O'Leary Sant Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI)

Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale

Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by the Global Response Assessment (GRA)

+1 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 MonthsActive Control1 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 PeriodActive Control1 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 PeriodPlacebo Group1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Interstitial Cystitis (IC) often aim to modulate cellular activity and reduce inflammation, which are crucial for managing the chronic pain and urinary symptoms associated with the condition. For instance, Low-Frequency Pulsed Electromagnetic Field (PEMF) Therapy is believed to work by influencing cellular functions and reducing inflammatory responses, thereby alleviating pain and improving bladder function. Similarly, other treatments like intravesical instillation of lidocaine and heparin aim to soothe the bladder lining and reduce inflammation. These mechanisms are vital for IC patients as they directly target the underlying pathophysiological processes, offering symptom relief and improving quality of life.