Sacral neuromodulation for the management of chronic pelvic pain

骶神经调节治疗慢性盆腔疼痛

• 批准号: 10837385
• 负责人: KENNETH M PETERS
• 金额: $ 56.2万
• 依托单位: WILLIAM BEAUMONT HOSPITAL RESEARCH INST
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10837385
• 关键词: Address; Adult; Affect; Anxiety Disorders; Applications Grants; Area; Chronic Care; Clinical Research; Complex; Cost Analysis; Data; Device Removal; Devices; Dialysis procedure; Disease; Etiology; FDA approved; Fecal Incontinence; Female; Fostering; Frequencies; Functional disorder; Funding; Implant; Incidence; International; Measures; Mental Depression; Mental Health; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Malignant; Organ; Outcome; Outcome Measure; Outcome Study; Pain; Pain management; Participant; Pathology; Patient Care; Patients; Pelvic Pain; Pelvis; Persistent pain; Phase; Phenotype; Placebo Effect; Placebos; Population; Procedures; Quality of life; Questionnaires; Research; Retrospective Studies; Sex Functioning; Sleep Disorders; Standardization; Structure; Symptoms; Syndrome; Testing; Time; Treatment Efficacy; Urinary Incontinence; Urinary Retention; Urology; Woman; body system; care costs; care seeking; central sensitization; chronic pelvic pain; comorbidity; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; effectiveness evaluation; experience; falls; implantation; improved; innovation; men; minimally invasive; neuroregulation; pain patient; pain reduction; placebo controlled trial; prospective; psychologic; response; secondary outcome; standard of care; treatment strategy; urinary; urologic chronic pelvic pain syndrome

ABSTRACT Pelvic pain syndromes are one of the most prevalent and challenging conditions for clinicians today. They have a higher incidence in women than men and are estimated to affect 6.4 – 25.4% of adult women worldwide. Chronic pelvic pain (CPP) is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months and can have a wide variety of etiologies. CPP has a debilitating effect on quality of life, equivalent to those on dialysis, and is associated with psychological comorbidity including depression, anxiety, and sleep disorders. Identifying the origin of the pelvic pain is typically the first step when choosing a treatment strategy. However, identifying the etiology can be challenging in part because pain associated with CPP is thought to become centralized over time and the dysfunction of one organ system often resulting in pathologies in other organs. Given the complex co-morbid conditions that define the phenotype of most patients with CPP, any treatment that may potentially improve several downstream pelvic organs and/or symptoms is desirable. As such, we propose to use sacral neuromodulation (SNM) as a treatment for CPP. SNM is a safe, effective, and minimally invasive procedure used to treat urinary and fecal incontinence, frequency, urgency, and urinary retention. Numerous retrospective studies have demonstrated a reduction in pelvic pain as a secondary outcome measure with SNM. However, to date, no prospective placebo-controlled trial has been performed to assess the effectiveness of SNM for pelvic pain specifically, in part because SNM is currently not an FDA approved treatment for CPP. Thus, we hypothesize that sacral neuromodulation is effective at reducing pain in patients suffering from chronic pelvic pain syndrome. We further hypothesize that single stage SNM implantation is more cost-effective and provides higher benefit to pelvic pain patients than the standard-of-care 2-stage approach. Our hypothesis will be tested through two specific aims: 1. Assess effectiveness of SNM in treating chronic pelvic pain syndrome in women; 2. Evaluate cost-effectiveness of single stage versus standard-of-care 2-stage SNM. Beaumont Urology is internationally recognized for its expertise in neuromodulation and a large number of women with CPP seek care at our Women’s Urology Center annually. Thus, our team is well-suited to successfully complete these aims. The outcomes of this study will have a far-reaching impact as it has the potential to significantly improve care for CPP and simultaneously address many unknowns in the field of neuromodulation, such as determine the placebo and carry-over effects. As such, study falls within the mission of this RFA to foster new and improved treatment and pain management strategies for patients and to address specific NIDDK disorders of key importance, namely Urologic Chronic Pelvic Pain Syndrome.

抽象的 骨盆疼痛综合征是当今临床医生最普遍，最挑战的状况之一。他们有 女性的事件比男性高，估计影响6.4 - 25.4％的成年女性。 慢性骨盆疼痛（CPP）被定义为在结构或器官中感知的非恶性持续疼痛 骨盆至少6个月，并且可以具有多种病因。 CPP对质量有衰弱的影响 生活，等于透析的人，与心理合并症有关，包括抑郁症， 焦虑和睡眠障碍。选择一个时，识别骨盆疼痛的起源通常是第一步 治疗策略。但是，识别病因可以部分挑战，部分原因是 CPP被认为会随着时间的流逝而集中，并且一个器官系统的功能障碍通常导致 其他器官中的病理。 鉴于定义大多数CPP患者的表型的复杂合并状况，任何治疗 希望可以改善几个下游骨盆器官和/或症状。因此，我们 建议使用s骨神经调节（SNM）作为CPP的治疗方法。 SNM是安全，有效且最少的 用于治疗尿液和粪便失禁，频率，紧迫性和尿retention留的侵入性程序。 许多回顾性研究表明，作为次要结果，骨盆疼痛减少了 用SNM测量。但是，迄今为止，尚未进行预期的安慰剂对照试验来评估 SNM对骨盆疼痛的有效性特别是因为SNM目前尚未获得FDA批准 CPP的治疗。这，我们假设s骨神经调节可有效减轻疼痛 患有慢性骨盆疼痛综合征的患者。我们进一步假设单阶段SNM 植入更具成本效益，并为骨盆疼痛患者带来更高的益处 标准的2阶段方法。 我们的假设将通过两个具体目标进行检验：1。评估SNM治疗慢性的有效性 女性骨盆疼痛综合征； 2。评估单阶段与护理标准的成本效益 2阶段SNM。博蒙特泌尿科因其在神经调节方面的专业知识而受到国际认可 CPP的女性每年在我们的妇女泌尿外科中心寻求护理。那，我们的团队非常适合 成功完成这些目标。 这项研究的结果将产生深远的影响，因为它有可能大大改善护理 对于CPP，仅处理神经调节领域的许多未知数，例如确定 安慰剂和背负效果。因此，研究属于此RFA的使命，以促进新的和改进 患者的治疗和疼痛管理策略并解决关键的特定NIDDK疾病 重要性，即泌尿科慢性骨盆疼痛综合征。