Actively Recruiting
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Led by Regina Elena Cancer Institute · Updated on 2024-06-04
158
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.
CONDITIONS
Official Title
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 75 years or younger
- Diagnosed with low-risk prostate cancer (PSA <10 ng/mL, Gleason Score <7, ISUP grade 1, cT1-2a) undergoing nerve-sparing robot-assisted radical prostatectomy
- Preoperative IIEF-5 score of 17 or higher
- First PSA measurement 45 days after surgery less than 0.2
- Able and willing to comply with study procedures and complete IIEF-5 and quality of life questionnaires
- Able to provide written informed consent for the trial
You will not qualify if you...
- Contraindications to robotic surgery related to anesthesia
- Previous pelvic radiotherapy or androgen deprivation therapy
- Major postoperative complications classified as Clavien-Dindo grade 3 or higher
- Cardiovascular contraindications to PDE5 inhibitor treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
G
Giuseppe Simone, Doctor
CONTACT
R
Riccardo Mastroianni, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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