Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

项目总结 这项先导性和可行性临床试验的目标是获得有关安全性和有效性的初步数据。 无创脉冲电磁场治疗间质疼痛的研究进展 膀胱炎/膀胱痛综合征(IC/BPS)患者。我们提供的初步数据表明IC/BPS 由至少两个不同的表型亚群组成；一个亚群的特征是以膀胱为中心的疾病 另一例为非以膀胱为中心的全身性疼痛综合征。我们建议利用 我们的大型患者数据库招募患者参加这项临床试验，我们将测试 电磁场疗法。该试验将采用单点、随机、双盲、假安慰剂对照研究 设计。为了实现本次临床试验的目标，我们提出了以下三个具体目标。 具体目的1：确定PEMF治疗对IC/BPS患者疼痛减轻的影响。从我们的 登记488名IC/BPS患者我们将招募60名符合所有纳入/排除条件的成年女性患者 标准包括：(1)30名使用BC≤400型麻醉剂的患者(即，以膀胱为中心的表型)，以及 (2)30例BC&GT；400毫升麻醉剂患者(即非以膀胱为中心的(全身性)表型)； 目前的数字分级疼痛评分为≥6。两个表型组中每一组的患者 将被随机分配(1：1比例)到PEMF治疗组或假手术组，在诊所接受使用培训 然后在家中接受为期四周的每天两次的PEMF治疗(或假治疗)。 假装置在所有方面都与治疗装置相同，除了它不提供脉冲 电磁场。患者将在登记时进行评估，在4周治疗期后的随访中进行评估， 然后在接下来的3个月里每月一次。主要的结果衡量标准是他们的骨盆发生了显著的变化 疼痛评分(即≥2降低)。次要结果将通过经过验证的IC/BPS问卷进行评估 (O‘Leary-Sant)、排尿特征(排尿日记)、简明疼痛清单(BPI)简表、盆腔疼痛和 紧急程度/频率(PUF)患者症状量表和全球反应评估(GRA)。 具体目标2：确定有无维持的PEMF治疗的受益持续时间 治疗。另外还将招募15名患有非膀胱中心性IC/BPS的成年女性患者 并接受标准的四周疗程，然后每月一周，每天两次的PEMF治疗 再进行3个月的养生。主要和次要结果将按月进行评估，最长可达4个月， 如目标1所述。结果将与仅治疗4周的非以膀胱为中心的患者进行比较 如果来自目标1的结果显示两组之间的阳性反应没有差异， 或者PEMF治疗对以膀胱为中心的患者比非以膀胱为中心的患者更有好处，那么患者 AIM 2的构成将相应调整(即每组8名患者(N=16)，或全部15名患者将是膀胱癌)。 中心)和对照组别(S)将作相应调整。

PROJECT SUMMARY The goal of this pilot and feasibility clinical trial is to acquire preliminary data regarding the safety and efficacy of the non-invasive pulsed electromagnetic field (PEMF) therapy for pain management in interstitial cystitis/bladder pain syndrome (IC/BPS) patients. We present preliminary data suggesting that IC/BPS comprises at least two distinct phenotypic subpopulations; one characterized as a bladder-centric disease process and the other characterized as a non-bladder-centric systemic pain syndrome. We propose to leverage our large patient database to recruit patients into this clinical trial wherein we will test the safety and efficacy of PEMF therapy. The trial will employ a single-site, randomized, double-blind, sham placebo-controlled study design. To accomplish the goals of this clinical trial, we propose the following three Specific Aims. Specific Aim 1: Determine the impact of PEMF therapy on pain reduction in IC/BPS patients. From our registry of 488 IC/BPS patients we will recruit 60 adult female patients who have met all inclusion/exclusion criteria, that includes: (1) 30 patients with an anesthetic BC≤400 anesthetic (i.e., bladder centric phenotype), and (2) 30 patients with an anesthetic BC>400 cc (i.e., those with a non-bladder centric (systemic) phenotype); all having a current numeric rating scale (NRS) pain score of ≥6. Patients within each of the two phenotypic groups will be randomly assigned (1:1 ratio) to either the PEMF treatment or sham group, trained in the clinic on the use of the PEMF device, and then undergo twice daily PEMF therapy (or sham) sessions at home for four weeks. The sham device is identical in every way to the treatment devices except it does not deliver a pulsed electromagnetic field. Patients will be assessed at enrollment, at follow-up after the 4-week treatment period, and then monthly for the next 3 months. The primary outcome measure will be a significant change in their pelvic pain score (i.e., a decrease ≥ 2). Secondary outcomes will be assessed by validated IC/BPS questionnaires (O’Leary-Sant), voiding characteristics (voiding diary), Brief Pain Inventory (BPI) Short Form, Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, and Global Response Assessment (GRA). Specific Aim 2: Determine the duration of benefit from PEMF therapy with and without maintenance treatments. An additional cohort of 15 adult female patients with non-bladder centric IC/BPS will be recruited and undergo the standard 4-week regimen, followed by a one-week-per-month of twice daily PEMF therapy regimen for an additional 3 months. Primary and secondary outcomes will be assessed monthly, out to 4 months, as described in Aim 1. The results will be compared to the non-bladder centric patients treated for 4 weeks only in Aim 1. If results from Aim 1 show that there is no difference in the positive response between the two groups, or that PEMF therapy benefits bladder-centric patients more than non-bladder centric patients, then the patient make-up for Aim 2 will be adjusted accordingly (i.e., 8 patients from each group (N=16), or all 15 will be bladder- centric, respectively) and the comparator group(s) will be adjusted accordingly.