PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome

NCT04540887 | Completed Results FDA Device

• 1 other identifier: IRB00068066
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information from the investigation of a non-pharmacological (non-drug) treatment known as low frequency pulsed electromagnetic field (PEMF). The study team will be distributing the PEMF therapy to female subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) to measure its ability to decrease pelvic pain. The results, from multiple questionnaires and voiding diaries, will be compared when participants are enrolled for treatment, at 4 weeks after using PEMF therapy, and 12 weeks post-enrollment.

Conditions

Interstitial Cystitis; Chronic Interstitial Cystitis; Bladder Pain Syndrome

Keywords

Interstitial Cystitis; Bladder Pain Syndrome; Painful Bladder Syndrome; IC; BPS; Painful Bladder; Urinary urgency; Urinary frequency; Nocturia; Urinary incontinence

Outcome Measures

Primary Outcomes (3)

• Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

  The NRS evaluates average pain intensity. It appears as a horizontal line with an eleven-point range. The NRS is labeled from 0 to 10, with 0 indicating no pain and 10 indicating severe pain ("worst pain imaginable").

  Baseline before beginning treatment

• Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

  The NRS evaluates average pain intensity. It appears as a horizontal line with an eleven-point range. The NRS is labeled from 0 to 10, with 0 indicating no pain and 10 indicating severe pain ("worst pain imaginable").

  Week 4

• Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)

  The NRS evaluates average pain intensity. It appears as a horizontal line with an eleven-point range. The NRS is labeled from 0 to 10, with 0 indicating no pain and 10 indicating severe pain ("worst pain imaginable").

  Week 12

Secondary Outcomes (6)

• Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)

  Baseline before beginning treatment, Week 4, and Week 12

• Change in IC/BPS Symptoms, as Measured by Wake Forest Baptist Health IC/BPS Global Response Assessment (GRA)

  Baseline, 4-weeks post-treatment, and 8-weeks post-treatment

• Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)

  Baseline before beginning treatment, Week 4, and Week 12

• Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Void and Intake Measurements

  Baseline before beginning treatment and Week 4

• Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Number of Voids

  Baseline before beginning treatment and Week 4

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (whole body mat), B. Pad (targeted pelvic mat), and Control Unit. The participant will lay the B. Body mat on any flat surface (i.e. floor, bed, reclining chair, etc.) and lie down on the mat with the smaller B. Pad placed directly over their pelvic area. Then, the participant will turn the PEMF device on using the attached control unit, which 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 four-week period. As this is a single-group assignment, all participants will be given the PEMF device.

Device: Pulsed Electromagnetic Field (PEMF) Therapy

Interventions

Pulsed Electromagnetic Field (PEMF) Therapy DEVICE

PEMF therapy will be self-administered by all trial participants using the B. Body, B. Pad, and Control Unit. Participants will administer this therapy twice a day (morning and evening) for 8-minute sessions over a four week period.

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

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients between 18 and 80 years old
• Participants must have already been diagnosed with interstitial cystitis/bladder pain syndrome
• Subjects must have a bladder capacity greater than 400 cc
• Participants must have scored at least a 6 or higher on Numeric Rating Scale questionnaire
• Participants must not have any cognitive disabilities
• Participants must not have taken any narcotic medication for at least three months before being enrolled in this clinical trial

You may not qualify if:

• Participants must not have any history of bladder, uterine, ovarian, or vaginal cancer, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, radiation cystitis, cyclophosphamide treatment, or genital herpes
• Patients cannot have an implanted pace-maker or metal prosthesis
• Participants cannot have a urinary tract infection at the time of enrollment or be currently pregnant
• Patients must not have a body mass index greater than 40

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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; Nocturia; Urinary Incontinence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Limitations and Caveats

The primary limitation of this pilot clinical trial was the small sample size and absence of a control group. We recognize the potential for a significant placebo effect among this patient population. Furthermore, our results are non-generalizable as we evaluated only females, and only those that were considered to have a non-bladder centric IC/BPS phenotype. To mitigate these shortcomings, the next iteration of this trial will employ a randomized, double-blind, sham-controlled study design.

Results Point of Contact

• Title: Dr. Stephen Walker
• Organization: Wake Forest Institute for Regenerative Medicine

swalker@wakehealth.edu

33-713-7272

Study Officials

• Stephen Walker, PhD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center clinical series evaluating symptom relief following a 4-week trial of PEMF therapy. From our registry of IC/BPS patients at Wake Forest Baptist Health Urology we will recruit women, ages 18-80, who have met all inclusion and exclusion criteria. Upon enrollment, each participant will be taught how to administer home treatment with the Bio Electro Magnetic Energy Regulation (BEMER) PEMF devices which consist of a total body mat (B.Body) plus a targeted pelvic mat (B.Pad) and control unit. Following the brief in-clinic training, participants will be sent home with the PEMF devices (preset to deliver the same level of energy every time) and self-administer therapy sessions, twice daily (once in the morning, once in the evening) for 8 minutes at a time. Participants will complete questionnaires as well as keep a 3-day voiding diary to record any changes in IC/BPS symptoms/pain at enrollment, 4 weeks after using PEMF therapy, and 12 weeks post-enrollment.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: February 24, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 5, 2022
• Results First Posted: July 20, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)