RBR-4ngnx3b尚未招募Unknown
Safety and Tolerability of a novel implantable Nerve Stimulator to ameliorate Erectile Function: a first study in men living with Spinal Cord Injury
E Pizolato Preparacao de Documentos e Servicos Especializados de Apoio Administrativo0 个研究点开始时间: 2023年5月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 55Y（—）
- 性别
- Male
入选标准
- •Men; 18 to 55 years old; traumatic spinal cord injury; injury less than 1 year ago; treat erectile dysfunction; responsive to PDE5 inhibitors; IIEF-15 score is equal to or less than 25 points.
排除标准
- •Spinal injury at T6 or above; history of autonomic dysreflexia; known allergies to any device material (Platinum/Iridium, Silicone, Pellethane, Titanium, Polysulfone, Polyurethane); contraindicated for surgery under general anesthesia; PSA greater than 4.0ng/mL; priapism or Peyronie's disease; hypertension; previous pelvic surgery; irradiation therapy; current use of an implantable penile device; diagnosed with a progressive degenerative neurological disease that can negatively impair erectile function; diabetes mellitus suffering from peripheral neuropathy or other complications associated with diabetes; not interested in sexual activity; currently participate in other clinical investigations; depression or abnormal behavior; IIEF-15 score equal to or greater than 26 points; high risk of prostate cancer, as determined by a positive PSA test.
研究者
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