Actively Recruiting
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Led by Regina Elena Cancer Institute · Updated on 2024-12-05
158
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- PSA less than 10 ng/mL
- Prostate Cancer ISUP grade 2 or lower and clinical stage cT2 or lower at prostate biopsy
- Undergoing nerve-sparing Robot-Assisted Radical Prostatectomy (RARP)
- Preoperative International Index of Erectile Function-5 (IIEF-5) score 17 or higher
- First PSA 45 days after surgery less than 0.1
- Prostate Cancer ISUP grade 2 or lower and pathological stage less than 3b at final pathology
- Patients able to comply with the study protocol and complete IIEF-5 and quality of life questionnaires
- Patients able to provide written informed consent for the trial
You will not qualify if you...
- Anesthetic contraindications to robotic surgery
- Patients who have received pelvic radiotherapy or androgen deprivation therapy
- Patients with major postoperative complications classified as Clavien Dindo grade 3 or higher
- Cardiovascular contraindications to PDE5 inhibitor treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
IRCCS "Regina Elena" National Cancer Institute
Rome, RM, Italy, 00144
Actively Recruiting
2
IRCCS "Fondazione G. Pascale" National Cancer Institute
Naples, Italy, 80131
Actively Recruiting
Research Team
G
Giuseppe Simone
CONTACT
R
Riccardo Mastroianni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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