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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-75
SponsorRegina Elena Cancer Institute

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)

Treatment groups

158 Participants
are divided into 2 treatment groups

Sponsors and collaborators