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.
Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Tadalafil at a dose of 5mg/day
"Regina Elena" National Cancer Institute
Rome, Italy
RECRUITINGImpact of LiESWT
To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot
Time frame: 3 years
Assess how many patients reach orgasm
Compare the rate of patients achieving orgasm. The International Index of Erectile Function short form (IIEF-5) questionnaire is the recognized tool for assessing erectile function both before surgery and during follow-up.
Time frame: 3 years
Questionnaires of Quality of life
Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.
Time frame: 3 years
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