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NCT06717711
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Conditions: Prostate Carcinoma, Erectile Function, Genito Urinary Cancer
Sex: Male
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 158
Sponsor: Regina Elena Cancer Institute
Location: IRCCS "Regina Elena" National Cancer Institute Rome RM
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 Criteria
Inclusion Criteria:
* Patients aged ≤75 yrs;
* PSA \
Source: ClinicalTrials.gov (NCT06717711). StuddyBuddy aggregates publicly available trial information.