RECRUITING

Investigation of PEMF Therapy for Female Patients With IC/BPS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-29
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05149573

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previously established clinical diagnosis of IC/PS
  2. * Current numeric rating scale (NRS) score of ≥ 6
  3. * History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia
  4. * No cognitive deficits
  1. * History of bladder, ovarian, vaginal cancer
  2. * History of urethral diverticulum
  3. * History of radiation cystitis
  4. * History of spinal cord injury or spina bifida
  5. * History of Parkinson's disease, multiple sclerosis, or stroke
  6. * Current placement of a pacemaker or metal prosthesis
  7. * Active urinary tract infection
  8. * BMI \> 40
  9. * Residual urine of \> 100cc
  10. * Current pregnant

Contacts and Locations

Study Contact

Stephen J Walker, PhD
CONTACT
336-713-7272
swalker@wakehealth.edu
Kaylee A Ferrara, BS
CONTACT
336-713-1693
kferrara@wakehealth.edu

Principal Investigator

Stephen J Walker, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-29
Study Completion Date2025-04

Study Record Updates

Study Start Date2022-08-29
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • interstitial cystitis
  • bladder pain syndrome
  • painful bladder syndrome
  • painful bladder
  • bladder pain
  • urinary urgency
  • urinary frequency
  • pulsed electromagnetic field

Additional Relevant MeSH Terms

  • Interstitial Cystitis
  • Chronic Interstitial Cystitis
  • Bladder Pain Syndrome