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NOT YET RECRUITING
NCT06013449
NA

Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Investigation of the Effect of Simultaneous Pulsed Electromagnetic Field (PEMF) and Intravesical Heparin - Bupivacaine Cocktail Instillation for the Symptomatic Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09

Completion Date

2027-12

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

Pulsed Electromagnetic Field (PEMF) Device

Pulsed Electromagnetic Field (PEMF) Device BEMER Device consist of a total body mat (B. BODY) plus a targeted pelvic mat (B.PAD), and a Control Unit which powers the device and logs usage. Both B.BODY and B.PAD must be plugged into the Control Unit simultaneously and activated individually. B. Body must be placed on a flat surface (i.e. bed, floor, reclining chair etc.) for best results.

DEVICE

Sham Pulsed Electromagnetic Feild (PEMF) Device

The sham PEMF device appears identical to the BEMER PEMF device, with all of the same components and accessories, but does not emit a pulsed electromagnetic field.

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States