Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of sexual function by increase satisfaction and good vaginal penetration
研究概览
简要总结
The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.
详细描述
60 patients for whom nerve sparing radical cystoprostatectomy will be carrried out, penile rehabilitation by using low intensity extracorporeal shock wave therapy will be applied in 20 patients, another 20 patients will receive oral phosphodiestrase type 5 inhibitorrs and 20 patients will not receive any interventions in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible if he is sexually motivated and potent men with stable relationship of more than 6 months duration who will undergo nerve sparing radical cysto-prostatectomy for organ-confined bladder cancer.
排除标准
- •Men with Peyronie's disease.
- •Inflammation in the shock wave area.
- •Evidence of disease failure after surgery.
- •Patients developing postoperative complications requiring hospital readmission after surgery which interferes with the process of SWL.
- •Unstable medical or psychiatric disorder.
研究组 & 干预措施
LI-ESWT group
Intervention include that patients will undergo penile low-intensity extracorporeal shock wave therapy, 6-12 sessions, 1500 shocks per session, two sesssions per week for 3 weeks then 3 weeks break and then 2 sessions per week for 3 weeks.
干预措施: LI-ESWT group (Device)
PDE-5 inhibitors group
Intervention include that patients will intke oral tablets of PDE-5 inhibitors :
- Oral intake of 50 mg once daily for 6 months.
干预措施: PDE-5 inhibitors group (Drug)
结局指标
主要结局
Improvement of sexual function by increase satisfaction and good vaginal penetration
时间窗: 6 MOTHES
increase in IIEF score by 5 degrees
次要结局
未报告次要终点
研究者
Tamer Zewin
Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University
Mansoura University