Clinical Trial

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

Study acronym: RCT_LiESWT

Recruiting Phase 3

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.

Protocol Amendment History 2 changes

notable Primary completion pushed: 2025-08-31 -> 2027-02-28 2026-08-15

minor Completion pushed: 2026-08-31 -> 2028-02-28 2026-08-15

Trial Details

NCT Number	NCT06717711
Lead Sponsor	Regina Elena Cancer Institute
Conditions	Prostate Carcinoma, Erectile Function, Genito Urinary Cancer
Enrollment	158 participants
Start Date	2023-09-15
Primary Completion	2027-02-28 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-14