Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Erectile Function
研究概览
简要总结
This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
详细描述
Background / State of Art ED is a common complication after radical prostatectomy, with a prevalence ranging from 40% to 80% of patients 1,2.
This considerable variability depends on the degree (intrafascial vs interfascial) and laterality (unilateral vs bilateral) of nerve sparing performed, as well as the surgical approach.
There is still paucity of high-level evidences in terms of impact of surgical approach on postoperative outcomes after RP. Considering the same surgical approach, technique, surgeon experience, patient age and preoperative erectile function remain the main predictors of postoperative sexual function.
In this context rehabilitation is still debatable and there is a lack of clear recommendations regarding the use of PDE5i and other forms of therapy. However, a multi-centre double blind RCT (n = 423) in men aged < 68 years, with normal pre-treatment erectile function undergoing either open, conventional or robot-assisted laparoscopic nerve-sparing RP, tadalafil (5 mg) once per day improved participants EPIC (Expanded Prostate Cancer Index Composite) sexual domain-scores (least squares mean difference +9.6, 95% CI: 3.1-16.0) when compared to 20 mg 'on demand' or placebo at 9 months of follow-up 3. As a result, there has been a trend toward early use of PDE5i after RP as demonstrated in some studies 4.
Hypothesis and specific aims Hypothesis and Significance The use of nerve-sparing techniques during robotic surgery has been shown to improve recovery of erectile function. However, some patients still experience ED after undergoing bilateral nerve-sparing RARP. Possible causes can be the mechanical stretching or thermal damage to cavernous nerves, ischemic injuries or local inflammation caused by surgery itself 5. Moreover, after surgery this condition could be exacerbated by an increased fibrosis and decreased elasticity of the erectile tissue in the corpora cavernosa.
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
- Single (Outcomes Assessor)
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;
- •PSA <10 ng/mL
- •Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- •undergoing nerve sparing RARP;
- •preoperative IIEF-5 score ≥ 17;
- •First PSA (45d after surgery) <0.1
- •Prostate Cancer ISUP grade ≤2 pT<3b and at final pathology
- •≥ 18 yrs old;
- •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
PDE5i + LiESWT
Patients receiving LiESWT plus early introduction of PDE5i
干预措施: Low-intensity Extracorporeal Shock Wave Therapy (LiESWT) (Device)
PDE5i + LiESWT
Patients receiving LiESWT plus early introduction of PDE5i
干预措施: PDE5 inhibitor (tadalafil) (Drug)
PDE5i alone
Control group, patients receiving PDE5i alone
干预措施: PDE5 inhibitor (tadalafil) (Drug)
结局指标
主要结局
Erectile Function
时间窗: From enrollment to 1 year after treatment
To investigate the impact of LiESWT in combination with early PDE5i administration versus early PDE5i alone on the penile rehabilitation of erectile dysfunction (ED) after RARP
次要结局
- Urinary Continence(From enrollment to 1 year after treatment)
- Adverse effects(From enrollment to 1 year after treatment)
- Health Related Quality of Life(From enrollment to 1 year after treatment)
研究者
Giuseppe SImone
MD
Regina Elena Cancer Institute