Erectile Dysfunction
Conditions
Brief summary
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.
Detailed description
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
Interventions
PROCEDURETadalafil (PDE5i)
Tadalafil at a dose of 5mg/day
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≤75 yrs; * Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP; * preoperative IIEF-5 score ≥ 17; * First PSA (45d after surgery) \<0.2 * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of LiESWT | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess how many patients reach orgasm | 3 years | 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. |
| Questionnaires of Quality of life | 3 years | Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment. |
Countries
Italy
Contacts
Primary ContactGiuseppe Simone, Doctor
Backup ContactRiccardo Mastroianni, Doctor
Outcome results
None listed