Recruiting

PEMF Therapy

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05149573

Conditions

Interstitial Cystitis

Chronic Interstitial Cystitis

Bladder Pain Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulsed Electromagnetic Field (PEMF) Device

Sham Pulsed Electromagnetic Field (PEMF) Device

Study Details

Brief summary:

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.

Conditions

Interstitial Cystitis

Chronic Interstitial Cystitis

Bladder Pain Syndrome

Study ID

NCT05149573

Start date

Aug 29, 2022

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Pulsed Electromagnetic Field (PEMF) 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

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.

Primary outcome measure

  • Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Baseline ]
  • Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Week 4 ]
  • Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Week 8 ]
  • Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Week 12 ]
  • Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Stephen J Walker, PhD

336-713-7272Stephen.J.Walker@advocatehealth.org

Kaylee A Ferrara, BS

336-713-1693Kaylee.Ferrara@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Stephen J Walker, PhD

336-713-7272Stephen.J.Walker@advocatehealth.org

Kaylee A Ferrarra, BS

336-713-1693Kaylee.Ferrara@Advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • interstitial cystitis
  • bladder pain syndrome
  • painful bladder syndrome
  • painful bladder
  • bladder pain
  • urinary urgency
  • urinary frequency
  • pulsed electromagnetic field

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-07.