Sacral neuromodulation for the management of chronic pelvic pain

摘要 盆腔疼痛综合征是当今临床医生最常见和最具挑战性的疾病之一。他们有 女性的发病率高于男性，估计全世界6.4-25.4%的成年女性会受到影响。 慢性盆腔疼痛(CPP)是指慢性盆腔结构或器官的非恶性持续性疼痛 骨盆至少6个月，病因多种多样。CPP对质量有削弱作用 相当于那些接受透析的人，并与包括抑郁在内的心理共病有关， 焦虑和睡眠障碍。确定盆腔疼痛的起因通常是选择 治疗策略。然而，确定病因可能具有挑战性，部分原因是疼痛与 CPP被认为随着时间的推移而集中，一个器官系统的功能障碍经常导致 其他器官的病理学。 鉴于复杂的合并症定义了大多数CPP患者的表型，任何治疗 这可能会潜在地改善几个下游的盆腔器官和/或症状是可取的。因此，我们 建议采用神经调节疗法(SNM)治疗慢性前列腺炎。SNM是一种安全、有效和最低限度的 用于治疗尿失禁和大便失禁的侵入性手术，包括尿失禁的频率、紧迫度和尿液滞留。 大量的回顾性研究表明，盆腔疼痛的减轻是次要的结果。 使用SNM进行测量。然而，到目前为止，还没有进行前瞻性的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目前不是FDA批准的 CPP的治疗。因此，我们假设，骶骨神经调节在减轻疼痛方面是有效的。 患有慢性盆腔疼痛综合征的患者。我们进一步假设单级SNM 植入物的成本效益更高，对盆腔疼痛患者的益处也更大。 标准护理两阶段方法。 我们的假设将通过两个特定的目标来检验：1.评估SNM在治疗慢性疾病方面的有效性 女性盆腔疼痛综合征；2.评价单期护理与标准护理的成本-效果 2级SNM。博蒙特泌尿科因其在神经调节方面的专业知识而在国际上得到公认，并为 每年有许多患有CPP的妇女到我们的妇女泌尿外科中心寻求治疗。因此，我们的团队非常适合 为了成功地完成这些目标。 这项研究的结果将产生深远的影响，因为它有可能显著改善医疗保健 并同时解决神经调节领域的许多未知数，例如确定 安慰剂和结转效应。因此，这项研究属于本RFA的使命，即促进新的和改进的 针对患者的治疗和疼痛管理策略以及针对特定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.