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

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Device & Drug
  • PHASE3
  • Regina Elena Cancer Institute
  • 18 - 75 Years


Study Purpose

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.

Intervention

Device : Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)

Drug : PDE5 inhibitor (tadalafil)


Eligibility Requirements

info icon Patients aged ≤75 yrs;

info icon PSA \<10 ng/mL

info icon Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy

info icon undergoing nerve sparing RARP;

info icon preoperative IIEF-5 score ≥ 17;

info icon First PSA (45d after surgery) \<0.1

info icon Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology

info icon ≥ 18 yrs old;

info icon compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;

info icon patients able to provide a written informed consent for the trial.

info icon Minimum age: 18

info icon anaesthesiologic contraindications to robotic surgery

info icon patients submitted to pelvic radiotherapy or androgen deprivation

info icon patients reporting major postoperative complications (CD≥3)

info icon cardiovascular contraindications to PDE5i medical treatment

Recruiting status

Recruiting

Estimated enrollment

158

 
Study start date

Aug 31, 2024

Study end date

Aug 31, 2026

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Device & Drug

Study phase

PHASE3

Allocation

Randomized

 

Sponsor:

Regina Elena Cancer Institute

Collaborator:

N/A

Investigator:

N/A

NCT06717711

Clinic Location Investigator Distance RECRUITING STATUS Contact