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: 10593955
• 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/10593955
• 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; 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; antinociception; 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.

项目总结