About this trial
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.
Eligibility criteria
Qualifiers
Patients aged ≤75 yrs;
PSA <10 ng/mL
Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
undergoing nerve sparing RARP;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
- PDE5 inhibitor (tadalafil)