Investigation of PEMF Therapy for Female Patients With IC/BPS

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

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

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

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

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

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

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

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

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

The ICSI (score range: 0-19 points) and ICPI (score range: 0-16 points) contain 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. 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.

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

The PUF Patient Symptom Scale is a validated instrument used to assess the severity of symptoms associated with IC/BPS and the degree to which these symptoms "bother" a patient. It is separated into two subsections, scored individually as the Symptom Score and Bother Score, to produce one composite score. The symptom score is comprised of 7 items addressing urinary frequency, urgency, nocturia, dyspareunia, and pelvic pain. Each question is scored from 0 (never) to 3 (always) or 1 (mild) to 3 (severe), except for two which quantify daytime frequency and nocturia separately with scores ranging from 0 to 4. A composite score between 10 and 14 indicates a strong diagnosis of IC/BPS with higher scores reflecting a greater degree of severity of symptoms and disease progressions as well as impact on quality of life.

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

The GRA is a single item, validated metric used to evaluate how ultimately effective a treatment method is from the perception of the patient. The GRA is structured on a 7-point scale centered at 0, indicating no change. The scales moves 3 points to the right of zero, indicating slight improvement, moderate improvement, and marked improvement, respectively, and 3 points to the left of zero, indicating slight worsening, moderate worsening, and marked worsening, respectively.

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

The voiding diary is a complete 3-day assessment of urinary symptoms (as they specifically pertain to IC/BPS) where patients themselves fill out quantitative and/or qualitative information in four categories at the time of each void: A) time of void, B) volume of voided urine (in mL) C) the severity of pain prior to void on a 0-10 numeric rating scale (NRS), D) the severity of pain 15 minutes after voiding on a 0-10 NRS, and E) time the participant went to bed at night and woke up in the morning. Following the completion of the 3-day voiding diary, the following four categories are calculated into quantifiable scores: 1) the total number of voids, 2) mean and total volume (in mL) of voided urine, 3) mean pre-voiding NRS pain score, and 4) mean post-voiding NRS score