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Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Sponsor: Regina Elena Cancer Institute
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.
Key Details
Gender
MALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2024-08-31
Completion Date
2026-08-31
Last Updated
2024-12-05
Healthy Volunteers
No
Interventions
Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ/mm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.
PDE5 inhibitor (tadalafil)
Phosphodiesterase-5 (PDE5) inhibitors
Locations (2)
IRCCS "Regina Elena" National Cancer Institute
Rome, RM, Italy
IRCCS "Fondazione G. Pascale" National Cancer Institute
Naples, Italy