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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12, and week 16
Awards & highlights

Study Summary

This trial is looking at whether a non-invasive, non-drug therapy called low-frequency pulsed electromagnetic field (PEMF) therapy is safe and effective for treating Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Secondary outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,857 Total Patients Enrolled
6 Trials studying Interstitial Cystitis
187 Patients Enrolled for Interstitial Cystitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,570 Total Patients Enrolled
13 Trials studying Interstitial Cystitis
2,333 Patients Enrolled for Interstitial Cystitis
Stephen J Walker, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
30 Total Patients Enrolled
2 Trials studying Interstitial Cystitis
30 Patients Enrolled for Interstitial Cystitis

Media Library

Pulsed Electromagnetic Field (PEMF) Device (Electromagnetic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05149573 — N/A
Interstitial Cystitis Research Study Groups: 4-Week Sham Treatment with no Maintenance Period, 4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months, 4-Week Treatment with no Maintenance Period
Interstitial Cystitis Clinical Trial 2023: Pulsed Electromagnetic Field (PEMF) Device Highlights & Side Effects. Trial Name: NCT05149573 — N/A
Pulsed Electromagnetic Field (PEMF) Device (Electromagnetic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05149573 — N/A
~22 spots leftby Apr 2025