Investigation of PEMF Therapy for Female Patients With IC/BPS

Description

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.

Conditions

Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome

Study Overview

Study Details

Study overview

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.

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

Investigation of PEMF Therapy for Female Patients With IC/BPS

Condition
Interstitial Cystitis
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Stephen J Walker, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-04