Recruiting

Pulsed Electromagnetic Field Therapy for Women with Interstitial Cystitis/Bladder Pain Syndrome

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Study Aim

This study aims to evaluate the effectiveness of pulsed electromagnetic field therapy in reducing pelvic pain for women suffering from interstitial cystitis or bladder pain syndrome.

What is being tested

Pulsed Electromagnetic Field (PEMF) Device

+ Sham Pulsed Electromagnetic Field (PEMF) Device

Device
Who is being recruted

Urogenital Diseases+5

+ Urinary Bladder Diseases

+ Cystitis

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Study ContactStephen J Walker, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 29, 2022

Actual date on which the first participant was enrolled.

This study explores the use of Pulsed Electromagnetic Field (PEMF) therapy to help women experiencing Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), a condition causing chronic pelvic pain and urinary issues. IC/BPS is challenging to treat because it involves a mix of symptoms and potential causes, such as inflammation and nerve problems. Current treatments often do not fully relieve symptoms, so finding new solutions is important. PEMF therapy, which has been used safely for conditions like arthritis and chronic pain, may offer a new, non-invasive way to reduce pain for women with IC/BPS, potentially improving their quality of life. In the study, participants receive PEMF therapy and are monitored over a four-month period to see if it reduces their pain and improves their symptoms. Researchers use a questionnaire called the Brief Pain Inventory (BPI) Short Form to measure changes in pain levels and how pain affects daily activities. This questionnaire helps track whether the therapy makes a significant difference in the participants' lives. The study also investigates whether continued PEMF treatments provide lasting benefits. The safety and effectiveness of PEMF therapy are key focus points, with successful results potentially leading to larger studies in the future.

Official TitleInvestigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
NCT05149573
Principal SponsorWake Forest University Health Sciences
Study ContactStephen J Walker, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesCystitisFemale Urogenital Diseases and Pregnancy ComplicationsUrologic DiseasesCystitis, InterstitialFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Group III

Sham
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Wake Forest University Health Sciences

Winston-Salem, United StatesOpen Wake Forest University Health Sciences in Google Maps
Recruiting
One Study Center