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

PHASE3RecruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
Prostate CarcinomaErectile FunctionGenito Urinary Cancer
Interventions
DEVICE

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.

DRUG

PDE5 inhibitor (tadalafil)

Phosphodiesterase-5 (PDE5) inhibitors

Trial Locations (2)

80131

RECRUITING

"IRCCS Fondazione G. Pascale National Cancer Institute", Naples

00144

RECRUITING

"IRCCS Regina Elena National Cancer Institute", Rome

All Listed Sponsors
lead

Regina Elena Cancer Institute

OTHER