Overview
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.
Description
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
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.