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

NCT06717711 · Regina Elena Cancer Institute · Updated 14 Aug 2026

What is being tested
Low-intensity Extracorporeal Shock Wave Therapy (LiESWT); PDE5 inhibitor (tadalafil)
For
Prostate Carcinoma; Erectile Function; Genito Urinary Cancer
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years to 75 years. About 158 people. The full rules are on the registry page.
Where
Italy (2 sites)
When
Starts or started 15 Sept 2023, ends 28 Feb 2028. Registered 5 Dec 2024.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06717711

Sites

  • IRCCS "Regina Elena" National Cancer InstituteRome, RM, Italy
  • IRCCS "Fondazione G. Pascale" National Cancer InstituteNaples, Italy