RecruitingNot ApplicableNCT05149573

Investigation of PEMF Therapy for Female Patients With IC/BPS

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

Sponsor

Wake Forest University Health Sciences

Enrollment

75 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Interstitial Cystitis Bladder Pain Syndrome Chronic Interstitial Cystitis

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria10

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

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Interventions

DEVICEPulsed 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.

DEVICESham 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.