An interventional study of Pulsed Electromagnetic Field (PEMF) Therapy in Interstitial Cystitis, Chronic Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
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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.
Also known as: BEMER B. Body, BEMER B. Pad, BEMER Control Unit
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").
Time frame: 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").
Time frame: 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").
Time frame: Week 12
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.
Time frame: 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)
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
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.
Time frame: Baseline before beginning treatment, Week 4, and Week 12
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.
Time frame: Baseline before beginning treatment and Week 4
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.
Time frame: Baseline before beginning treatment and Week 4
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.
Time frame: Baseline before beginning treatment and Week 4
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.
| Milestone | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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").
| score on a scale | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Pelvic Pain, as Measured by the Numeric Rating Scale (NRS) | 6.70 ± 0.675 |
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").
| score on a scale | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS) | 4.18 ± 1.462 |
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").
| score on a scale | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Change From Baseline Pelvic Pain, as Measured by the Numeric Rating Scale (NRS) | 5.34 ± 1.845 |
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.
| scores on a scale | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Baseline | 13 ± 1.927 |
| Week 4 | 9.125 ± 4.581 |
| Week 12 | 10.75 ± 3.742 |
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.
| score on a scale | Treatment |
|---|---|
| Baseline | 0 (0 to 0) |
| 4-weeks post-treatment | 2 (1 to 2) |
| 8-weeks post-treatment | 2 (1 to 3) |
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.
| scores on a scale | Treatment |
|---|---|
| Baseline before beginning treatment | 13.875 ± 2.949 |
| Week 4 | 9 ± 4.781 |
| Week 12 | 10 ± 3.741 |
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.
| mL | Treatment |
|---|---|
| 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 |
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.
| voids | Treatment |
|---|---|
| Daily Number of Voids (Baseline) | 13.79 ± 3.33 |
| Daily Number of Voids (Week 4) | 11.52 ± 1.79 |
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.
| Score on a scale | Treatment |
|---|---|
| Urgency Score (range from 0-4) (Baseline) | 2.12 ± 0.70 |
| Urgency Score (range from 0-4) (Week 4) | 1.91 ± 0.586 |
Collected over 36 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulsed Electromagnetic Field Therapy (PEMF) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Median | 52 (47.75 to 60.0) |
| Sex: Female, Male(Participants) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Female | 10 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| United States | 10 |
| Numeric Rating Scale (NRS) Score(units on a scale) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Mean | 6.875 ± 0.641 |
| Length of IC/BPS Diagnosis(years) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Mean | 10.7 ± 5.335 |
| Body Mass Index (BMI)(kg/m^2) | Pulsed Electromagnetic Field Therapy (PEMF) |
|---|---|
| Mean | 26.34 ± 6.507 |
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