NCT05256498撤回不适用
Electrophysiological Studies of the Human Pudendal Nerve Using Short-duration Extracorporeal Stimulation
Amber Therapeutics Ltd0 个研究点开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Intraoperative pelvic floor electromyography (EMG)
研究概览
简要总结
AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
- •Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
- •Ability and willingness to give informed consent
- •Willingness to stay overnight in hospital after SNM procedure (as per routine care)
排除标准
- •Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) [this is an exclusion for SNM in any case]
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
- •Any psychiatric or personality disorder at the discretion of the study physician
- •Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
- •Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
- •Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
- •Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
- •Patient is not suitable for the study as determined by their routine care physician for any other reason
- •Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
- •Patient participation in vigorous sporting activities where these cannot be restricted for a period of 24h while the extracorporeal lead is in situ.
- •Specific urological
- •As per routine clinical SNM criteria (see: https://www.nice.org.uk/guidance/ipg6434)
- •Specific technical
- •Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
- •Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
- •Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
结局指标
主要结局
Intraoperative pelvic floor electromyography (EMG)
时间窗: 24 Hours
Intra-operative measurements of amplitude of pelvic floor EMG upon pudendal nerve stimulation
次要结局
- Pelvic floor electromyography (EMG)(24 Hours)
- Technical outcomes(24 Hours)
研究者
相似试验
终止
不适用
Electrophysiologic Mapping of the BladderElectrical Evaluation of Urinary BladderNCT02041442Englewood Hospital and Medical Center8
已完成
不适用
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor FunctionPelvic FloorNCT04482426Cathay General Hospital112
已完成
不适用
Previously Implanted Pudendal Nerve StimulationUrinary RetentionUnderactive BladderNCT04473469University of Michigan5
已完成
不适用
Amplifying Sensation in Underactive BladderUrinary Bladder, UnderactiveNCT04516434Duke University20
已完成
不适用
Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEGConsciousness, Loss ofRefractory EpilepsyNCT06575413Xuanwu Hospital, Beijing8