PEMF Therapy to Treat Interstitial Cystitis/Bladder Pain Syndrome
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pelvic Pain, as Measured by the Numeric Rating Scale (NRS) [Baseline before beginning treatment]
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) [Week 4]
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) [Week 12]
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) [Baseline before beginning treatment, Week 4, and Week 12]
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) [Baseline, 4-weeks post-treatment, and 8-weeks post-treatment]
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) [Baseline before beginning treatment, Week 4, and Week 12]
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 [Baseline before beginning treatment and Week 4]
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 [Baseline before beginning treatment and Week 4]
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 [Baseline before beginning treatment and Week 4]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Stephen Walker, PhD, Wake Forest Health Sciences
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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. Review.
- 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. Review.
- 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. Epub 2007 Sep 20. Review.
- 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. Review.
- IRB00068066
Study Results
Participant Flow
| Recruitment Details | Participants were recruited based on physician referral from the existing database of patients with interstitial cystitis seen at Wake Forest Baptist Health Urology between February 2021 and November 2021. One participant was identified and enrolled via direct communication with investigators based on information found on clinicaltrials.gov. |
|---|---|
| Pre-assignment Detail | Of 10 enrolled participants, 10 were successfully screened and met all inclusion criteria. However, 2 of the 10 participants experienced exigent personal circumstances and voluntarily withdrew from the study before their 4-week follow-up visit. These participants were subsequently excluded from data analysis. |
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 8 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Overall Participants | 10 |
| Age (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
52
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
10
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
10
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
10
100%
|
| Numeric Rating Scale (NRS) Score (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
6.875
(0.641)
|
| Length of IC/BPS Diagnosis (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
10.7
(5.335)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
26.34
(6.507)
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Measure Participants | 10 |
| Mean (Standard Deviation) [score on a scale] |
6.70
(0.675)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Measure Participants | 8 |
| Mean (Standard Deviation) [score on a scale] |
4.18
(1.462)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Measure Participants | 8 |
| Mean (Standard Deviation) [score on a scale] |
5.34
(1.845)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants initially enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. These participants were included in the baseline data analysis but were excluded from the 4- and 8-week post-enrollment data analysis. |
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. |
| Measure Participants | 10 |
| Baseline |
13
(1.927)
|
| Week 4 |
9.125
(4.581)
|
| Week 12 |
10.75
(3.742)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants initially enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. These participants were included in the baseline data analysis but were excluded from the 4- and 8-week post-enrollment data analysis. Additionally, 1 patient at the 4-week post-treatment evaluation and 3 patients in the 8-week post-treatment evaluation did not specifically list PEMF therapy in the GRA, and therefore their data were excluded from analysis. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group 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. Pulsed Electromagnetic Field (PEMF) Therapy: 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. |
| Measure Participants | 10 |
| Baseline |
0
|
| 4-weeks post-treatment |
2
|
| 8-weeks post-treatment |
2
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants initially enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. These participants were included in the baseline data analysis but were excluded from Week 4 and Week 12 data analysis. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group 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. Pulsed Electromagnetic Field (PEMF) Therapy: 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. |
| Measure Participants | 10 |
| Baseline before beginning treatment |
13.875
(2.949)
|
| Week 4 |
9
(4.781)
|
| Week 12 |
10
(3.741)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. Their data was excluded from data analysis. Additionally, of the remaining 8 participants, 2 failed to complete their voiding diaries in its entirety and one additional participant did not complete her fluid intake. Thus, 6 women had evaluable voiding information and 5 had data for fluid intake to evaluate. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group 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. Pulsed Electromagnetic Field (PEMF) Therapy: 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. |
| Measure Participants | 10 |
| Total Urine Volume (TUV in mL) (Baseline) |
2808.68
(1498.93)
|
| Total Urine Volume (TUV in mL) (Week 4) |
2511.67
(1514.67)
|
| Maximum Voided Volume (MVV in mL) (Baseline) |
406.71
(234.13)
|
| Maximum Voided Volume (MVV in mL) (Week 4) |
454.29
(307.60)
|
| Mean Voided Volume (mL) (Baseline) |
215.45
(116.38)
|
| Mean Voided Volume (mL) (Week 4) |
229.67
(140.63)
|
| Fluid Intake (Baseline) |
1701.52
(600.00)
|
| Fluid Intake (Week 4) |
1594.69
(668.17)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. Their data was excluded from data analysis. Additionally, of the remaining 8 participants, 2 failed to complete their voiding diaries in its entirety. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group 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. Pulsed Electromagnetic Field (PEMF) Therapy: 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. |
| Measure Participants | 10 |
| Daily Number of Voids (Baseline) |
13.79
(3.33)
|
| Daily Number of Voids (Week 4) |
11.52
(1.79)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 10 participants enrolled, 2 experienced exigent personal circumstances and voluntarily withdrew from the study. Their data was excluded from data analysis. Additionally, of the remaining 8 participants, 2 failed to complete their voiding diaries in its entirety. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group 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. Pulsed Electromagnetic Field (PEMF) Therapy: 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. |
| Measure Participants | 10 |
| Urgency Score (range from 0-4) (Baseline) |
2.12
(0.70)
|
| Urgency Score (range from 0-4) (Week 4) |
1.91
(0.586)
|
Adverse Events
| Time Frame | 36 Weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pulsed Electromagnetic Field Therapy (PEMF) | |
| Arm/Group 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, fully reclined chair, etc.) and lie down on the mat with their spine straight and the smaller B. Pad straddled between their legs with the coils placed directly over the pelvic area. The participant will then turn the PEMF device on using the attached control unit, which has been pre-programmed to deliver the same amount and intensity 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. | |
All Cause Mortality |
||
| Pulsed Electromagnetic Field Therapy (PEMF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Serious Adverse Events |
||
| Pulsed Electromagnetic Field Therapy (PEMF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Pulsed Electromagnetic Field Therapy (PEMF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Stephen Walker |
|---|---|
| Organization | Wake Forest Institute for Regenerative Medicine |
| Phone | 33-713-7272 |
| swalker@wakehealth.edu |
- IRB00068066