Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
Erectile Dysfunction Following Radical Prostatectomy
About this trial
This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria: Patients who underwent radical prostatectomy (open, laparoscopic or robotic-assisted) with nerve-sparing (unilateral or bilateral). Low / intermediate-risk prostate cancer PSA < 20 ng/ml Gleason score < 8 Prostate cancer pathological stage </= T2b Sexually active with IIEF-5 score 3 18, with or without use of erectogenic aid / PDE5i. Exclusion Criteria: Tumour upstaging beyond T2b Neurovascular bundle tissues bilaterally in the histopathological report. Scheduled treatment with pelvic radiotherapy and / or androgen deprivation therapy post-RP. Men with ED of neuropathological, endocrine or psychogenic origin. Previous pelvic surgery or radiation therapy. Patients with uncontrolled psychiatric conditions. Patients with major post-operative complications that could impact safety or effectiveness of ESWT. Patients with heart disease - unable to take PDE5i or prohibited from sexual activity. Patients on anticoagulation / antiplatelets except aspirin up to 100mg daily. Inflammation in the shockwave area or having penile pathology such as Peyronie's disease.
Sites / Locations
- Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Standard Care + Active LiESWT
Standard Care + Sham LiESWT
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study. With or without Vacuum Pump Active LiESWT
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study. With or without Vacuum Pump Sham LiESWT