Investigation of PEMF Therapy for Female Patients With IC/BPS

NCT05149573 | Recruiting FDA Device

• 2 other identifiers: IRB000790061R01DK128233-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis; Chronic Interstitial Cystitis; Bladder Pain Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

  The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Baseline

• Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

  The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 4

• Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

  The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 8

• Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

  The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 12

• Change from baseline pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form

  The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

  Week 16

Secondary Outcomes (4)

• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by O'Leary Sant Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI)

  Baseline, Week 4, Week 8, Week 12, and Week 16

• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale

  Baseline, Week 4, Week 8, Week 12, and Week 16

• Change in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms, as measured by the Global Response Assessment (GRA)

  Baseline, Week 4, Week 8, Week 12, and Week 16

• Change in Urinary symptoms, as measured by 3-day voiding diaries

  Baseline, Week 4, Week 8, Week 12, and Week 16

Study Arms (3)

4-Week Treatment with no Maintenance Period

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.

Device: Pulsed Electromagnetic Field (PEMF) Device

4-Week Sham Treatment with no Maintenance Period

SHAM COMPARATOR

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.

Device: Sham Pulsed Electromagnetic Field (PEMF) Device

4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months

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.

Device: Pulsed Electromagnetic Field (PEMF) Device

Interventions

Pulsed Electromagnetic Field (PEMF) Device 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.

Also known as: BEMER PEMF, BEMER B. Body, BEMER B. Pad, BEMER Control Unit

4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months; 4-Week Treatment with no Maintenance Period

Sham Pulsed Electromagnetic Field (PEMF) Device 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.

4-Week Sham Treatment with no Maintenance Period

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Subject must be biologically Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (5)

• van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.

  PMID: 17900797 BACKGROUND

• Vasudevan V, Moldwin R. Addressing quality of life in the patient with interstitial cystitis/bladder pain syndrome. Asian J Urol. 2017 Jan;4(1):50-54. doi: 10.1016/j.ajur.2016.08.014. Epub 2016 Dec 2.

  PMID: 29264207 BACKGROUND

• Keay SK, Birder LA, Chai TC. Evidence for bladder urothelial pathophysiology in functional bladder disorders. Biomed Res Int. 2014;2014:865463. doi: 10.1155/2014/865463. Epub 2014 May 8.

  PMID: 24900993 BACKGROUND

• Parsons CL. The role of a leaky epithelium and potassium in the generation of bladder symptoms in interstitial cystitis/overactive bladder, urethral syndrome, prostatitis and gynaecological chronic pelvic pain. BJU Int. 2011 Feb;107(3):370-5. doi: 10.1111/j.1464-410X.2010.09843.x. Epub 2010 Dec 22.

  PMID: 21176078 BACKGROUND

• Christmas TJ, Rode J, Chapple CR, Milroy EJ, Turner-Warwick RT. Nerve fibre proliferation in interstitial cystitis. Virchows Arch A Pathol Anat Histopathol. 1990;416(5):447-51. doi: 10.1007/BF01605152.

  PMID: 2107633 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stephen J Walker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen J Walker, PhD

CONTACT

336-713-7272; swalker@wakehealth.edu

Kaylee A Ferrara, BS

CONTACT

336-713-1693; kferrara@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and study investigator will not know whether the study participant has received PEMF (treatment) or Sham (control) therapy. Only the study coordinator, who will distribute the devices to study participants, will be unmasked to the therapies.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a double-blind, sham-controlled clinical trial separated into two Aims. Aim 1 will include 60 female adults with IC/BPS, divided into two groups: 1) 30 participants with an anesthetic bladder capacity (BC) ≤ 400cc and 2) 30 participants with BC \> 400cc. Patients within each of the two groups will be randomly assigned in a 1:1 ratio to either the PEMF (treatment) or Sham (control) group. The Sham device is identical to the treatment device but does not deliver PEMF. All participants will be instructed to use their device every day, morning and evening, for 8-minute sessions over a 4-week period. Aim 2 will include an additional cohort of 15 female adults with IC/BPS. These participants will undergo the standard 4-week regimen of PEMF therapy, followed by a one-week-per-month maintenance period of twice daily PEMF therapy for an additional 3 months post-enrollment (the fourth week in months 2, 3, and 4).

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: August 29, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)