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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 belowSelect...
I have had a bladder examination under anesthesia to measure its capacity.
Select...
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:Select...
I have had a urethral diverticulum.
Select...
I have a history of Parkinson's disease, multiple sclerosis, or stroke.
Select...
I have a history of bladder, ovarian, or vaginal cancer.
Select...
I have had bladder inflammation due to radiation.
Select...
I have had a spinal cord injury or spina bifida.
Select...
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
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 moreTrial 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
1,357 Previous Clinical Trials
1,031,615 Total Patients Enrolled
6 Trials studying Interstitial Cystitis
167 Patients Enrolled for Interstitial Cystitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,429 Previous Clinical Trials
4,322,739 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a urethral diverticulum.I have a history of Parkinson's disease, multiple sclerosis, or stroke.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.I have had bladder inflammation due to radiation.I have a history of bladder, ovarian, or vaginal cancer.You have a pacemaker or metal implant in your body.You have more than 100cc of urine left in your bladder after urinating.I have had a spinal cord injury or spina bifida.I currently have a urinary tract infection.You have a very high body mass index (BMI).I have been diagnosed with interstitial cystitis/painful bladder syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: 4-Week Sham Treatment with no Maintenance Period
- Group 2: 4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months
- Group 3: 4-Week Treatment with no Maintenance Period
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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