- Recruiting
- Treatment
- Interventional
- Randomized
- Device & Drug
- PHASE3
- Regina Elena Cancer Institute
- 18 - 75 Years
Study Purpose
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.
Intervention
Device : Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
Drug : PDE5 inhibitor (tadalafil)
Eligibility Requirements
Patients aged ≤75 yrs;
PSA \<10 ng/mL
Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
undergoing nerve sparing RARP;
preoperative IIEF-5 score ≥ 17;
First PSA (45d after surgery) \<0.1
Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology
≥ 18 yrs old;
compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
patients able to provide a written informed consent for the trial.
Minimum age: 18
anaesthesiologic contraindications to robotic surgery
patients submitted to pelvic radiotherapy or androgen deprivation
patients reporting major postoperative complications (CD≥3)
cardiovascular contraindications to PDE5i medical treatment
Recruiting status
Recruiting
Estimated enrollment
158
Study start date
Aug 31, 2024
Study end date
Aug 31, 2026
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Device & Drug
Study phase
PHASE3
Allocation
Randomized
Sponsor:
Regina Elena Cancer Institute
Collaborator:
N/A
Investigator:
N/A
Publications
Websites
N/A
NCT06717711
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