NCT03174470已完成不适用
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Ability to follow study instructions and complete study assessment tools
排除标准
- •History of cardiovascular disorders
- •Any type of implanted pacemaker/defibrillator
- •Hypertension
- •Diabetes Mellitus
- •Local dermatological disease
- •Local skin irritation/lesions
- •Any neurological disorder
- •Any psychiatric disease and/or psychiatric medications
研究组 & 干预措施
TENS stimulator
Experimental
Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)
干预措施: TENS Stimulator (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Baseline
Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations
次要结局
- Incidence of post-treatment Adverse Events(72 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)Aortic Valve StenosisNCT03483051University of Pennsylvania5
已完成
1 期
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCISpinal Cord InjuriesSpine DiseaseStrokeNCT05589402University of Texas Rio Grande Valley52
尚未招募
不适用
New Rehabilitation Protocol for Patients With PPPDRehabilitationBalanceVestibular DisorderDizzinessNCT05831618I.R.C.C.S. Fondazione Santa Lucia40
撤回
2 期
A Study of the Effects of Minocycline on Cognitive Function After Carotid EndarterectomyCarotid StenosisNCT00401921Brigham and Women's Hospital
已完成
4 期
A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation ApproachPersistent Atrial FibrillationNCT02654353Johannes Gutenberg University Mainz100