Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Stephen J Walker, PhD
swalker@wakehealth.edu
336-713-7272
Backup
Kaylee A Ferrara, BS
kferrara@wakehealth.edu
336-713-1693
Time Frame
Start Date: 2022-08-29
Estimated Completion Date: 2026-04
Participants
Target number of participants: 75
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

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