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
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator