Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Baseline

The BPI Short Form is a validated questionnaire used 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 a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 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 significant change in pain. The form also includes 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 3

The BPI Short Form is a validated questionnaire used 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 a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 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 significant change in pain. The form also includes 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.

Pelvic pain scores as measured by the Brief Pain Inventory (BPI) Short Form - Week 6

The BPI Short Form is a validated questionnaire used 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 a composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured by 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 significant change in pain. The form also includes 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) scores, as measured by the 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) contain 4 questions related to urinary and pain symptoms. For the ICSI, 3 of the 4 questions use a 0-5 range with 0 indicating that the symptom is never experienced and 5 indicating the symptom is always experienced. The fourth question uses a range of 0-4 with 0 indicating the symptom is never experienced, and 4 indicating that the symptom is almost always experienced. For the ICPI, all four questions use 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) scores, as measured by the 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 the Bother Score, to produce one composite score. The symptom score is comprised of seven 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 times. A composite score between 10 and 14 indicates a strong diagnosis of IC/BPS with higher scores reflecting a greater degree of symptom severity and disease progression as well as an impact on overall quality of life.

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

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

Change in Urinary Symptom scores, as measured by 3-day voiding diaries - Number of Urine Voids

The voiding diary is a complete 3-day assessment of urinary symptoms (as they specifically pertain to IC/BPS) where the patient fills out quantitative and/or qualitive information in five categories at the time of each void: time of void, volume of voided urine (in mL), the severity of pain prior to void (on a 1-10 NRS scale), the severity of urgency prior and post void (on a scale of 0-10 with 0 indicating no urgency and 10 indicating severe urgency), and the time the participant at night and woke in the morning. Following the completion of the voiding diary, the following 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, mean pre-voiding urgency, mean in post-voiding NRS pain score and mean post-void urgency score.