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RECRUITING Not applicable ClinicalTrials.gov

Investigation of PEMF Therapy for Female Patients With IC/BPS

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT05149573

Registry updated: 2026-09-28
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Description

The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC/BPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline/enrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.

Interventions

  • Pulsed Electromagnetic Field (PEMF) Device (Device)
    BEMER PEMF device consists of a B. Body (full body mat), B. Pad (targeted pelvic pad), and Control Unit which powers the device. Both B. Body and B. Pad must be plugged in simultaneously into the Control Unit and activated individually. B. Body must be placed on a flat surface (e.g. floor, bed, reclining chair, etc) for best results.
  • Sham Pulsed Electromagnetic Field (PEMF) Device (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.

Eligibility criteria

Inclusion Criteria: * Previously established clinical diagnosis of IC/PS * Current numeric rating scale (NRS) score of ≥ 6 * History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia * No cognitive deficits Exclusion Criteria: * History of bladder, ovarian, vaginal cancer * History of urethral diverticulum * History of radiation cystitis * History of spinal cord injury or spina bifida * History of Parkinson's disease, multiple sclerosis, or stroke * Current placement of a pacemaker or metal prosthesis * Active urinary tract infection * BMI \> 40 * Residual urine of \> 100cc * Current pregnant

Conditions

Interstitial Cystitis Chronic Interstitial Cystitis Bladder Pain Syndrome

Locations

  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record