Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

Summary

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

Inclusion Criteria:

* 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.

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

Conditions4

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