Sacral neuromodulation for the management of chronic pelvic pain

摘要 骨盆疼痛综合征是当今临床医生最普遍和最具挑战性的疾病之一。他们有 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）是指盆腔组织或器官的非恶性持续性疼痛， 骨盆至少6个月，可以有各种各样的病因。CPP对质量有削弱作用 与透析患者相当，并与包括抑郁症在内的心理并发症有关， 焦虑和睡眠障碍确定盆腔疼痛的起源通常是选择治疗方案的第一步。 治疗策略然而，确定病因可能具有挑战性，部分原因是与疼痛相关的疼痛。 CPP被认为随着时间的推移变得集中，并且一个器官系统的功能障碍通常导致 其他器官的病变。 考虑到定义大多数CPP患者表型的复杂共病状况，任何治疗 其可能潜在地改善若干下游盆腔器官和/或症状。因此我们 建议使用骶神经调节（SNM）治疗CPP。SNM是一种安全，有效， 用于治疗尿失禁和大便失禁、尿频、尿急和尿潴留的侵入性手术。 大量的回顾性研究表明，盆腔疼痛的减轻是次要结局 用SNM来衡量。然而，迄今为止，还没有进行前瞻性安慰剂对照试验来评估 SNM对骨盆疼痛的有效性，部分原因是SNM目前尚未获得FDA批准 治疗CPP。因此，我们假设骶神经调节在减轻疼痛方面是有效的。 患有慢性骨盆疼痛综合征的患者。我们进一步假设单级SNM 植入更具有成本效益，并为盆腔疼痛患者提供更高的获益， 标准治疗2阶段方法。 我们的假设将通过两个具体目标进行测试：1。评估SNM治疗慢性 女性盆腔疼痛综合征; 2.评价单阶段与标准治疗的成本效益 2-SNM期。博蒙泌尿科因其在神经调节方面的专业知识和 每年都有许多患有CPP的女性在我们的女性泌尿中心寻求护理。因此，我们的团队非常适合 成功实现这些目标。 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 并同时解决神经调节领域的许多未知问题，例如确定 安慰剂和残留效应。因此，研究福尔斯属于RFA的使命，即培养新的和改进的 治疗和疼痛管理策略，并解决特定的NIDDK疾病的关键 重要性，即泌尿系统慢性盆腔疼痛综合征。

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.