RecruitingPhase 3NCT06717711

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


Sponsor

Regina Elena Cancer Institute

Enrollment

158 participants

Start Date

Aug 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-intensity shockwave therapy — a non-invasive treatment using sound waves — can help restore erectile function in men who have had nerve-sparing robotic prostate cancer surgery. Erectile dysfunction is a common side effect of prostate surgery, and this study explores a possible rehabilitation approach. **You may be eligible if...** - You are 75 years old or younger - You had low-to-intermediate risk prostate cancer (PSA under 10, Gleason grade ≤2, clinical stage ≤T2) treated with nerve-sparing robotic surgery - Your erectile function was good before surgery (IIEF-5 score ≥17) - Your PSA after surgery is below 0.1 (indicating no cancer recurrence) - You have no cancer found beyond the prostate in the surgical specimen **You may NOT be eligible if...** - You have health conditions preventing surgery or anesthesia - You received pelvic radiotherapy or hormone therapy (androgen deprivation) - You had major complications from surgery - You have cardiovascular conditions that prevent using PDE5 inhibitors (like sildenafil) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow-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.

DRUGPDE5 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

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NCT06717711


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