PEMF Therapy for Interstitial Cystitis

Recruiting in Palo Alto (17 mi)

Stephen J. Walker, PhD | Wake Forest ...

Overseen byStephen Walker, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and/or associated symptoms of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) patients. The study team will distribute the PEMF device to female adults with IC/BPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone.

Eligibility Criteria

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).

Inclusion Criteria

No cognitive deficits

I have no allergies or reactions to the treatment solution.

I have been diagnosed with Interstitial Cystitis or Bladder Pain Syndrome.

See 2 more

Exclusion Criteria

I have had a spinal cord injury or spina bifida.

I have been diagnosed with Parkinson's Disease.

You have a pacemaker or metal implant in your body right now.

See 11 more

Treatment Details

Interventions

Pulsed Electromagnetic Field (PEMF) Therapy (Procedure)

Trial OverviewThe 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.

Participant Groups

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.