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Investigation of PEMF Therapy for Female Patients With IC/BPS

RecruitingNAAges 18 Years - 80 YearsFemaleWake Forest University Health Sciences
NCT05149573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Wake Forest University Health Sciences
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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