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

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 patie

Trial Details

NCT ID
NCT06717711
Phase
PHASE3
Sponsor
Regina Elena Cancer Institute
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
  • PDE5 inhibitor (tadalafil)
Locations (sample)
  • Rome, RM, Italy|41.89193,12.51133
  • Naples, Italy|40.85216,14.26811

Key Eligibility Criteria

  • Patients aged ≤75 yrs;
  • PSA \<10 ng/mL
  • Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
  • undergoing nerve sparing RARP;

For full eligibility, visit ClinicalTrials.gov.

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