Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Good general health
- •Clinical history of premature ejaculation
- •Familiar with self- stimulation
- •Ability to follow study instructions and complete study assessment tools
- •Washout period of two weeks
排除标准
- •History of cardio-vascular 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 any psychiatric medications
- •Any neoplastic disease in the past two years
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Procedure day
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Change in ejaculation latency time
时间窗: Procedure day
The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied
次要结局
- Incidence of post-treatment Adverse Events(72 hours)