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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 belowSelect...
I have had a bladder examination under anesthesia to measure its capacity.
Select...
I have been diagnosed with interstitial cystitis/painful bladder syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 8, week 12, and week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12, and week 16
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 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,132 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
2,357 Previous Clinical Trials
4,315,111 Total Patients Enrolled
13 Trials studying Interstitial Cystitis
2,542 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 Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months
- Group 2: 4-Week Sham Treatment with no Maintenance Period
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have thus far been recruited for this clinical trial?
"Yes, clinicaltrial.gov data affirms that the trial is presently looking for volunteers. Initially posted on August 29th 2022, this research will recruit 75 individuals from only one site."
Answered by AI
Are volunteers being recruited for this trial currently?
"Affirmative, the information available on clinicaltrials.gov confirms that this trial is open to new participants. It was first posted on August 29th 2022 and last updated November 2nd of the same year. The study requires 75 individuals from a single centre."
Answered by AI
What are the qualifications for enrollment in this medical experiment?
"This medical experiment is in search of 75 participants who are between 18 and 80 years old, have experienced a hydrodistension bladder capacity test under anaesthesia, been clinically diagnosed with IC/PS (Interstitial cystitis/Painful Bladder Syndrome), currently report an NRS score higher than 6, and lack cognitive impairments."
Answered by AI
Are applicants over the age of 35 being admitted to this clinical experiment?
"This research is currently admitting participants aged 18 or over and under 80 years old."
Answered by AI
What purpose does this clinical trial aim to fulfill?
"The primary aim of this investigation, which will be monitored over a Baseline period, is to assess changes in pelvic pain as determined by the Brief Pain Inventory (BPI) Short Form. Secondary objectives involve evaluating modifications in Interstitial cystitis/Bladder Pain Syndrome (IC/BPS) symptoms through measurement with both the Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale - comprised of 7 criteria scored from 0-3 or 1-3 depending on question type - and Global Response Assessment (GRA), a single item measure ranging 3 points either side of zero indicating no change respectively slight to"
Answered by AI
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