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

非侵入性脉冲电磁场​​ (PEMF) 治疗女性间质性膀胱炎/膀胱疼痛综合征 (IC/BPS) 患者的研究

• 批准号: 10446499
• 负责人: STEPHEN WALKER
• 金额: $ 31万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10446499
• 关键词: Adult; Analgesics; Anesthetics; Area; Bladder; Brief Pain Inventory; Characteristics; Clinic; Clinical Trials; Cognitive; Controlled Clinical Trials; Cystectomy; Data; Databases; Degenerative polyarthritis; Devices; Diagnosis; Disease; Double-Blind Method; Electrocoagulation; Electromagnetic Fields; Enrollment; Exclusion Criteria; Exhibits; Female; Fibromyalgia; Flare; Frequencies; Goals; Home; Inflammatory; Injections; Interstitial Cystitis; Intervention; Investigation; Lesion; Life; Maintenance; Microcirculation; Mission; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Numeric Rating Scale; Opioid Analgesics; Outcome Measure; Pain; Pain management; Patient Recruitments; Patients; Pelvic Pain; Pelvis; Phenotype; Physiologic pulse; Placebo Control; Process; Publishing; Quality of life; Questionnaires; Randomized; Regenerative capacity; Regimen; Registries; Research Design; Rheumatoid Arthritis; Risk; Safety; Site; Symptoms; Syndrome; Testing; Therapeutic; Training; Treatment Protocols; Urologist; Work; base; chronic painful condition; chronic pelvic pain; cohort; comparison group; diaries; experience; follow-up; pain perception; pain reduction; pain score; patient subsets; placebo controlled study; placebo group; primary outcome; recruit; regenerative tissue; response; safety testing; secondary outcome; treatment duration; treatment group

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.

项目概要 该试点和可行性临床试验的目标是获取有关安全性和有效性的初步数据 非侵入性脉冲电磁场​​ (PEMF) 疗法用于间质性疼痛管理 我们提供的初步数据表明，膀胱炎/膀胱疼痛综合征 (IC/BPS) 患者存在 IC/BPS。 包含至少两个不同的表型亚群；其中一个亚群的特征是膀胱中心疾病 过程和另一个特征是非膀胱中心的系统性疼痛，我们建议利用。 我们庞大的患者数据库招募患者参加这项临床试验，我们将测试其安全性和有效性 PEMF 疗法将采用单中心、随机、双盲、假安慰剂对照研究。 为了实现本临床试验的目标，我们提出以下三个具体目标。 具体目标 1：确定 PEMF 治疗对 IC/BPS 患者疼痛减轻的影响。 登记了 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 名麻醉剂 BC≤400 麻醉剂的患者（即膀胱中心表型），以及 (2) 30 名麻醉 BC>400 cc 的患者（即具有非膀胱中心（全身）表型的患者）； 两个表型组中当前数字评定量表 (NRS) 疼痛评分≥6 的患者。 将被随机分配（1:1 比例）到 PEMF 治疗组或假手术组，并在诊所接受使用培训 的 PEMF 装置，然后每天两次在家进行 PEMF 治疗（或假治疗）疗程，为期四个星期。 假手术装置在各方面都与治疗装置相同，只是它不提供脉冲 患者将在入组时、4 周治疗期后的随访时进行评估， 然后在接下来的 3 个月中每月进行一次，主要结果指标将是骨盆的显着变化。 疼痛评分（即下降 ≥ 2）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）、简短疼痛量表 (BPI) 简表、盆腔疼痛和 紧急程度/频率 (PUF) 患者症状量表和总体反应评估 (GRA)。 具体目标 2：确定有或没有维持的 PEMF 治疗的获益持续时间 将招募另外 15 名患有非膀胱中心 IC/BPS 的成年女性患者。 并接受标准的 4 周治疗方案，然后每月进行一周、每日两次的 PEMF 治疗 额外 3 个月的主要和次要结果将每月评估一次，持续 4 个月， 如目标 1 中所述。结果将与仅治疗 4 周的非膀胱中心患者进行比较 目标 1。如果目标 1 的结果表明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的益处多于非以膀胱为中心的患者，那么患者 目标 2 的组成将相应调整（即每组 8 名患者 (N=16)，或者所有 15 名患者均为膀胱癌） 分别为中心），并且比较组将进行相应调整。