Sacral neuromodulation for the management of chronic pelvic pain

骶神经调节治疗慢性盆腔疼痛

基本信息

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
项目类别：
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

项目摘要

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.

抽象的盆腔疼痛综合症是当今最普遍和最具挑战性的疾病之一。女性发病率高于男性，估计影响全球 6.4-25.4% 的成年女性。慢性盆腔疼痛（CPP）被定义为在盆腔结构或器官中感知到的非恶性持续性疼痛。骨盆持续至少 6 个月，并且可能有多种病因，CPP 会对质量产生削弱作用。与透析患者的生活水平相当，并且与包括抑郁症在内的心理共病有关，确定骨盆疼痛的根源通常是选择治疗方法的第一步。然而，确定病因可能具有挑战性，部分原因是疼痛与疼痛相关。 CPP被认为会随着时间的推移而变得集中，一个器官系统的功能障碍常常导致其他器官的病变。鉴于定义大多数 CPP 患者表型的复杂共病状况，任何治疗这可能会改善一些下游盆腔器官和/或症状，因此，我们是可取的。建议使用骶神经调节 (SNM) 作为 CPP 的治疗方法，SNM 是一种安全、有效且最低限度的治疗方法。用于治疗尿失禁、大便失禁、尿频、尿急和尿潴留的侵入性手术。许多回顾性研究表明，骨盆疼痛的减轻是次要结果然而，迄今为止，尚未进行前瞻性安慰剂对照试验来评估。 SNM 对盆腔疼痛的有效性，部分原因是 SNM 目前尚未获得 FDA 批准因此，我们发现骶神经调节可以有效减轻 CPP 的疼痛。我们进一步追求单阶段 SNM。与传统的植入相比，植入更具成本效益，并且为骨盆疼痛患者提供更高的益处。标准护理两阶段方法。我们的假设将通过两个具体目标进行检验： 1. 评估 SNM 在治疗慢性病方面的有效性女性盆腔疼痛综合征；2. 评估单阶段治疗与标准治疗的成本效益 2 阶段 SNM 因其在神经调节方面的专业知识和广泛的研究而受到国际认可。每年有大量患有 CPP 的女性到我们的女性泌尿科中心寻求治疗，因此，我们的团队非常适合。成功地完成这些目标。这项研究的结果将产生深远的影响，因为它有可能显着改善护理对于 CPP 并同时解决神经调节领域的许多未知问题，例如确定因此，本 RFA 的使命是促进新的和改进的研究。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，即泌尿科慢性盆腔疼痛综合征。