Investigation of PEMF Therapy for Female Patients With IC/BPS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

History of bladder, ovarian, vaginal cancer

History of urethral diverticulum

History of radiation cystitis

History of spinal cord injury or spina bifida

Trial design

Treatments tested in this trial

  • Pulsed Electromagnetic Field (PEMF) Device
  • Sham Pulsed Electromagnetic Field (PEMF) Device

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator