Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
研究概览
简要总结
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.
详细描述
Despite SNM being available for more than 25 years, there are many things about this technology that remain elusive. Enhancing our understanding of SNM in the chronic pelvic pain (CPP) population can rapidly improve the care of current patients suffering from pelvic pain, as well as help develop future technologies, stimulation paradigms, and lead to effective counseling of patients. CPP is one of most common and challenging conditions for clinicians to treat today. CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months. As such, CPP can be caused by numerous underlying conditions from gynecological (e.g. endometriosis), gastrointestinal (e.g. celiac disease, irritable bowel syndrome), urological (e.g. interstitial cystitis), musculoskeletal (e.g. fibromyalgia), prostatitis, and neurological/vascular (e.g. spinal cord injury, ilioinguinal nerve entrapment) origin. From a urological perspective, the pain in CPP syndrome can be associated with symptoms suggesting urinary, sexual or bowel dysfunction, and are commonly associated with Overactive Bladder (OAB) symptoms of urinary frequency, urgency, and incontinence. CPP has a debilitating effect on quality of life, leading to other comorbidities such as depression, anxiety, and sleep disorders. CPP is common in both men and women, but occurs more frequently in women. This study will assess the effectiveness of sacral neuromodulation in women.
This is a prospective single arm and single blinded quasi-placebo controlled study. Patients will be blinded to the device settings. For those that qualify, the sacral neuromodulation device will be placed by an experienced physician. After placement in the operating room the device settings will be adjusted. 2 weeks post-operatively participants return and complete study questionnaires. The devices settings will again be adjusted at this visit. The device may turned on/off, or settings modified throughout the study. To maintain study integrity, patients will not be informed how device settings are changed. At each follow up visit, participants will be asked to complete study questionnaires and will have their device settings adjusted. Participants will follow up over a course of 12 months from the time of device implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Device is turned on/off, or settings are modified throughout the study. The protocol specifies the exact timing of when the device is turned on/off and or settings are modified. All patients will be on the same schedule. To maintain study integrity, patients will not be informed how device settings are changed; however, since this is a single-arm study, "open label" has been chosen above. During the informed consent process, patients will be explained that throughout the study, the device settings will be modified and that some of these changes may result in symptoms improving while others may cause symptoms to worsen.
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, aged 22-70
- •Chronic pelvic pain (= pain below umbilicus) score of 4 or greater on 10-point VAS, present for 6 months or greater (screening patient)
- •Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations)
- •No changes to current regimen of medications for their pelvic pain for > 4 weeks prior to screening
- •For females of reproductive potential: use of highly effective contraception (e.g. licensed hormonal or barrier methods), for at least 1 month prior to screening and agreement to use such a method during study participation
- •Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint)
排除标准
- •History of any active pelvic cancer
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
- •Concurrent pain management strategies within the past 3 months that may interfere or mask study intervention (e.g. pelvic floor physical therapy, shockwave therapy, trigger point injections, bladder instillations)
- •Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders that are stable.
- •Current symptomatic urinary tract infection (UTI) or more than 6 UTIs in past year
- •Severe or uncontrolled diabetes (A1C > 7, documented in the last 3 months) or diabetes with peripheral nerve involvement
- •Interstitial cystitis diagnosis with Hunner's lesions as this is a severe inflammatory bladder condition that can only be treated with eradication of the lesions or a cystectomy. SNM would be be expected to help for IC with Hunner's lesions
- •Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial
- •Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone
- •Implantation of spinal cord stimulator and/or drug delivery pumps, whether turned on or off
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- •Current treatment for active malignancy (skin cancers excluded)
- •Patients with spinal pathology that could confound study results. This may include participants with cauda equina syndrome, spinal stenosis, neurogenic claudication, lumbar radiculopathy, patients with primary complaints of leg pain with numbness and or weakness, patients with a primary pain compliant that is vascular in origin, clinical evidence of progressive neurologic pathology, mechanical instability or other spinal pathology that requires surgical intervention, spine or visceral pain secondary to neoplasm, visceral pain in the upper abdomen rather than the pelvis, current diagnosis of fibromyalgia participants with significant cognitive impairment, participants with a condition currently requiring or likely to require use of diathermy or MRI or history of any other condition that in the opinion of the investigator could put the participant at risk or interfere with study results interpretation. (screening patient).
- •Participants involved in ongoing litigation and or injury claims or workers compensation claims.
- •Participation in a current clinical trial or within the preceding 30 days
- •Note- to preserve the scientific integrity of the study some criteria have been omitted from this posting. All eligibility criteria will be listed at the close of the study.
研究组 & 干预措施
SNM for the treatment of CPP
Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7.
干预措施: Sacral neuromodulation (Device)
结局指标
主要结局
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
时间窗: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)
The VAS is a validated tool to determine patient perceived pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 4 (10 weeks post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
次要结局
- The change in central sensitization score over 13 months(Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant))
- Change in pelvic floor pain using a 10-point VAS pain score.(Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant))
- Change in severity of overactive bladder symptoms.(Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant))
- Change in Female Sexual Function(Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant))
- Change in mental health and anxiety.(Visit 2 (2 weeks post-implant), Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant))
- Patient satisfaction with sacral neuromodulation treatment(Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant))
- Treatment durability measured as change in pain scores from baseline (visit 2) to visit 7 (12 months post-implant) as measured by 10-point visual-analog scale.(Visit 2 (2 weeks post-implant) and Visit 7 (12 months post-implant))
- Number of days of carry-over effect after short and long treatment (an average of 13 months post implant)(Visit 8 (an average of 13 months post-implant))
- Safety and tolerability: number of adverse events related to the device implantation.(Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant))
研究者
Kenneth M Peters, MD
Director and Chair of the Department of Urology
Corewell Health East