Investigation of PEMF Therapy for Female Patients With IC/BPS

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05149573
Status
Recruiting
Apply to this trial

Conditions

  • Bladder Pain Syndrome
  • Chronic Interstitial Cystitis
  • Interstitial Cystitis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 29, 2022
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 4-Week Treatment with no Maintenance Period
    Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.
  • Sham Comparator: 4-Week Sham Treatment with no Maintenance Period
    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 surface and lay on the mat with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the sham device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.
  • Active Comparator: 4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months
    Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will keep the device and use it for 1 week (7 days) during the last week of the month for the following 3 months. Each participant in this group will be asked to complete a set of electronic questionnaires immediately following their week-long maintenance treatment during the last 3 months of the study.

Primary Outcome Measure

Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Stephen J Walker, PhD
[email protected]
336-713-7272
Kaylee A Ferrarra, BS
[email protected]
336-713-1693

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