Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Impact of LiESWT
研究概览
简要总结
The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.
详细描述
Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≤75 yrs;
- •Low-risk PCa (PSA <10 ng/mL and GS <7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
- •preoperative IIEF-5 score ≥ 17;
- •First PSA (45d after surgery) <0.2
- •compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
- •patients able to provide a written informed consent for the trial.
排除标准
- •anaesthesiologic contraindications to robotic surgery;
- •patients submitted to pelvic radiotherapy or androgen deprivation;
- •patients reporting major postoperative complications (CD≥3);
- •cardiovascular contraindications to PDE5i medical treatment.
研究组 & 干预措施
GROUP 1: LiESWT in association with PDE5i
Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i
干预措施: Tadalafil (PDE5i) (Procedure)
GROUP 2: PDE5i alone
Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice
干预措施: Tadalafil (PDE5i) (Procedure)
结局指标
主要结局
Impact of LiESWT
时间窗: 3 years
To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot
次要结局
- Assess how many patients reach orgasm(3 years)
- Questionnaires of Quality of life(3 years)