search
Back to results

PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome

Primary Purpose

Interstitial Cystitis, Chronic Interstitial Cystitis, Bladder Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed Electromagnetic Field (PEMF) Therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Bladder Pain Syndrome, Painful Bladder Syndrome, IC, BPS, Painful Bladder, Urinary urgency, Urinary frequency, Nocturia, Urinary incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Wake Forest Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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").
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").
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").

Secondary Outcome Measures

Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)
The ICPI (score range: 0-16 points) contain four questions related to urinary and pain symptoms. For the problem index, all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem. Higher scores indicate more severe symptoms and greater disease progression, while lower scores indicate less severe symptoms and less disease progression.
Change in IC/BPS Symptoms, as Measured by Wake Forest Baptist Health IC/BPS Global Response Assessment (GRA)
The GRA asks participants to list any in-office treatments, home treatments, medications, or procedures they have had in the past year for IC/BPS. Then, they are asked to score those treatments based on a seven point scale (-3 to +3) with -3 indicating their symptoms became markedly worse and +3 indicating their symptoms were markedly improved after treatment.
Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
The ICSI (score range: 0-19 points) contains four questions related to urinary and pain symptoms. For the symptoms index, 3 of the 4 questions utilize a range of 0-5 with 0 indicated the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is almost always experienced. Higher scores indicate more severe symptoms and greater acuity of disease progression, while lower scores indicate less severe symptoms and lower acuity of disease progression.
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Void and Intake Measurements
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period. Data analysis will be measured based on urgency score, total urine volume (TUV) (mL), maximum voided volume (MVV) (mL), mean voided volume (mL), and fluid intake (mL). For TUV, MVV, and mean voided volume, higher voided volume (in mL) indicates more efficient bladder-emptying and less severe symptoms, while a lower voided volume (in mL) indicates less efficient bladder-emptying and more severe symptoms.
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Number of Voids
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes if applicable. Data analysis will be measured based on daily number of voids (voids). For number of voids specifically, a greater number of voids in a 24-hour period indicates increased urinary frequency and more severe symptoms, while a fewer number of voids in a 24-hour period indicates decreased urinary frequency and less severe symptoms.
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Urgency Score
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes if applicable. Data analysis will be measured based on urgency score (scale: 0-3, with 0 indicating no urgency and 3 indicating maximum urgency). For the urgency score specifically, lower scores indicate less severe urinary symptoms/urgency while higher scores indicate more severe urinary symptoms/urgency.

Full Information

First Posted
August 31, 2020
Last Updated
December 1, 2022
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04540887
Brief Title
PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome
Official Title
Investigation of Potential Therapeutic Effects of Pulsed Electromagnetic Field for the Treatment of Symptoms Associated With Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a clinical diagnosis based primarily on chronic symptoms of pain perceived by the patient to emanate from the bladder and/or pelvis associated with urinary urgency or frequency in the absence of another identified cause for the symptoms. Although it is not a life-threatening disease, the chronicity and severity of pain, along with urinary symptoms, causes great impairment in a patient's quality of life. IC/BPS poses as a significant clinical challenge for many reasons. For one, the pathophysiology described in the literature is incompletely determined and likely multi-factorial, including factors such as inflammation, neurovascular dysfunction, ion imbalance, and impaired urothelial cell integrity. Consequently, there are many options for IC/BPS therapy, many of which are driven primarily by patient-reported symptoms. In this regard, IC/BPS patients with moderate to severe pain typically require multi-modal therapy, often resulting in incomplete or no resolution of symptoms. Another clinical challenge is the heterogeneity of the symptoms. While pelvic pain is the distinguishing characteristic, patients with IC/BPS also routinely present with additional urological and non-urological medical symptoms and syndromes. This has led to the description of two specific sub-phenotypes in IC/BPS based on anesthetized bladder capacity (BC), in which patients with BC < 400 cc are more likely to experience severe pain, urgency and frequency (bladder centric sub-phenotype), and patients with BC > 400 cc (non-bladder centric sub-phenotype) have a higher prevalence of non-urological associated syndromes (NUAS) such as fibromyalgia, chronic fatigue symptoms, irritable bowel syndrome, endometriosis and sicca syndrome. Pulsed Electromagnetic Field (PEMF) therapy may present a promising alternative therapy for IC/BPS. PEMF is a safe, non-invasive, and effective therapy currently used for wound healing, bone-related diseases (osteoarthritis, RA), and chronic pain states (chronic lower back pain, fibromyalgia), the latter of which is frequently associated with IC/BPS as NUAS. Based on Faraday's law, electromagnetic interactions (e.g. PEMF) with biological processes and conditions (e.g. IC/BPS) will theoretically address many of the proposed pathophysiological causes of the condition. While the mechanism(s) of action are not fully understood, PEMF therapy has been shown in several studies (randomized, double-blinded, placebo-controlled trials) to decrease the output of pro-inflammatory proteins, improve oxygenation of blood and tissue, stabilize transmembrane action potential and ion channels, and stimulate tissue regeneration. Thus, PEMF may provide a safe, non-invasive therapeutic option that would be complementary to, or serve as an alternative for, the treatments that are currently being administered in IC/BPS for pain reduction. Of note, PEMF has demonstrated an excellent safety profile with no associated systemic risks reported to date. Additionally, the application of exogenous PEMF to stimulate the pelvic floor muscle has recently been introduced for treating urge and/or stress urinary incontinence and overactive bladder. Furthermore, if patient safety and efficacy for pain reduction are demonstrated, these feasibility studies will provide the foundation for larger multi-site trials to determine additional parameters regarding the appropriate number of treatments as well as the duration of benefit (pain relief) following treatments.The purpose of this study will be to determine if PEMF therapy in patients with IC/BPS is an effective treatment in reducing pelvic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pulsed Electromagnetic Field (PEMF) Therapy
Other Intervention Name(s)
BEMER B. Body, BEMER B. Pad, BEMER Control Unit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)
Description
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").
Time Frame
Baseline before beginning treatment
Title
Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)
Description
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").
Time Frame
Week 4
Title
Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS)
Description
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").
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)
Description
The ICPI (score range: 0-16 points) contain four questions related to urinary and pain symptoms. For the problem index, all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem. Higher scores indicate more severe symptoms and greater disease progression, while lower scores indicate less severe symptoms and less disease progression.
Time Frame
Baseline before beginning treatment, Week 4, and Week 12
Title
Change in IC/BPS Symptoms, as Measured by Wake Forest Baptist Health IC/BPS Global Response Assessment (GRA)
Description
The GRA asks participants to list any in-office treatments, home treatments, medications, or procedures they have had in the past year for IC/BPS. Then, they are asked to score those treatments based on a seven point scale (-3 to +3) with -3 indicating their symptoms became markedly worse and +3 indicating their symptoms were markedly improved after treatment.
Time Frame
Baseline, 4-weeks post-treatment, and 8-weeks post-treatment
Title
Change in IC/BPS Symptoms, as Measured by O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Description
The ICSI (score range: 0-19 points) contains four questions related to urinary and pain symptoms. For the symptoms index, 3 of the 4 questions utilize a range of 0-5 with 0 indicated the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is almost always experienced. Higher scores indicate more severe symptoms and greater acuity of disease progression, while lower scores indicate less severe symptoms and lower acuity of disease progression.
Time Frame
Baseline before beginning treatment, Week 4, and Week 12
Title
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Void and Intake Measurements
Description
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period. Data analysis will be measured based on urgency score, total urine volume (TUV) (mL), maximum voided volume (MVV) (mL), mean voided volume (mL), and fluid intake (mL). For TUV, MVV, and mean voided volume, higher voided volume (in mL) indicates more efficient bladder-emptying and less severe symptoms, while a lower voided volume (in mL) indicates less efficient bladder-emptying and more severe symptoms.
Time Frame
Baseline before beginning treatment and Week 4
Title
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Number of Voids
Description
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes if applicable. Data analysis will be measured based on daily number of voids (voids). For number of voids specifically, a greater number of voids in a 24-hour period indicates increased urinary frequency and more severe symptoms, while a fewer number of voids in a 24-hour period indicates decreased urinary frequency and less severe symptoms.
Time Frame
Baseline before beginning treatment and Week 4
Title
Change in IC/BPS Symptoms, as Recorded in Patient Voiding Diary - Urgency Score
Description
Participants will be instructed on how to complete 3-day voiding diary prior to initial office visit and following assessments. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes if applicable. Data analysis will be measured based on urgency score (scale: 0-3, with 0 indicating no urgency and 3 indicating maximum urgency). For the urgency score specifically, lower scores indicate less severe urinary symptoms/urgency while higher scores indicate more severe urinary symptoms/urgency.
Time Frame
Baseline before beginning treatment and Week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Walker, PhD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17900797
Citation
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.
Results Reference
background
PubMed Identifier
29264207
Citation
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.
Results Reference
background
PubMed Identifier
24900993
Citation
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.
Results Reference
background
PubMed Identifier
21176078
Citation
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.
Results Reference
background
PubMed Identifier
2107633
Citation
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.
Results Reference
background

Learn more about this trial

PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome

We'll reach out to this number within 24 hrs