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Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

NCT06013449 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Interstitial Cystitis
  • Chronic Interstitial Cystitis
  • Bladder Pain Syndrome

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stephen J Walker, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013449 on ClinicalTrials.gov