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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.

摘要