Intra-operative Neuromodulation of the Pelvic Plexus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Penile circumference increase in millimeters.
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).
详细描述
Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.
The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.
The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled for open radical prostatectomy procedure under total anesthesia.
- •Age 40 to 75 years old.
- •Able to read and understand patient information materials and willing to sign a written informed consent.
排除标准
- •Have been diagnosed with severe vasculogenic erectile dysfunction.
- •Have a prior history of pelvic surgery, trauma or irradiation therapy.
- •Have a penile prosthesis.
- •Have been diagnosed with neurologic diseases that may negatively impact erectile functions.
- •Currently having an active implantable device (such as a pacemaker).
- •Posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study.
- •Inability to provide a fully informed consent.
研究组 & 干预措施
Nerve Stimulation
Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.
干预措施: Nerve Stimulation (Device)
结局指标
主要结局
Penile circumference increase in millimeters.
时间窗: 5 minutes
Change in penile circumference \[mm\] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
次要结局
- Anatomic location of stimulation site(5 to 15 minutes)
- Stimulation threshold in volts(5 to 15 minutes)
研究者
Dr. Ioannis Adamakis
MD, Principal investigator
Laikο General Hospital, Athens