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PEMF Therapy for Interstitial Cystitis

N/A

Waitlist Available

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

Previously established clinical diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Be older than 18 years old

Must not have

History of spinal cord injury or spina bifida

History of Parkinson's Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 3 and week 6

Summary

This trial aims to test if using PEMF therapy with bladder instillations can reduce pain and symptoms in people with IC/BPS.

Who is the study for?

This trial is for adult women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who experience significant pain (NRS ≥ 5). They must have had a cystoscopy with bladder capacity measurement and no cognitive deficits. Exclusions include a history of certain cancers, urinary conditions, neurological disorders, pregnancy, pacemaker or metal prosthesis presence, active infections, or extreme obesity (BMI >40).

What is being tested?

The study tests if Pulsed Electromagnetic Field (PEMF) therapy combined with bladder instillations of bupivacaine-heparin can better reduce chronic pain and symptoms in IC/BPS patients than the instillation alone. Participants will receive either PEMF therapy or a sham device alongside their prescribed treatment.

What are the potential side effects?

Potential side effects may include discomfort from the PEMF device application area or reactions to the bupivacaine-heparin cocktail such as local irritation. The study aims to establish the safety profile of simultaneous PEMF therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Interstitial Cystitis or Bladder Pain 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 spinal cord injury or spina bifida.

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I have been diagnosed with Parkinson's Disease.

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I have had a stroke in the past.

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I have had bladder inflammation due to radiation.

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I have had genital herpes.

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I have had a urethral diverticulum.

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I currently have a urinary tract infection.

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I have had bladder, ovarian, or vaginal cancer in the past.

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I have been diagnosed with Multiple Sclerosis.

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I have been treated with cyclophosphamide.

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My BMI is over 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 3 and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 3 and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3 and week 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Baseline

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 3

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 6

Secondary study objectives

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

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

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

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine/heparin instillationsActive Control1 Intervention

Participants will be instructed to self-administer pulsed electromagnetic field therapy (PEMF) devices immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. PEMF therapy will be self-administered using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat dry surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control B. Box) has been pre-programmed to deliver the same energy level every time. Participants will be instructed to administer this home treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the PEMF device is returned.

Group II: 6-week Sham Treatment with intravesical bupivacaine/heparin instillationsPlacebo 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 dry surface and lay on the mat with with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment immediately following each intravesical bupivacaine/heparin instillation, while they are holding the instillation solution in their bladder. Participants will be instructed to administer this sham treatment in conjunction with their self-administered bladder instillations of bupivacaine/heparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the sham PEMF device is returned.

0 / 12Eligibility criteria met