Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Giuseppe Simone, Doctor
giuseppe.simone@ifo.it
06-5266.5005
Backup
Riccardo Mastroianni, Doctor
riccardo.mastroianni@ifo.it
06-5266.5005
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 158
Treatments
Experimental: GROUP 1: LiESWT in association with PDE5i
Therapeutic association between low intensity extracorporeal shock waves LiESWT and the early introduction of the phosphodiesterase 5 inhibitor PDE5i
Active_comparator: GROUP 2: PDE5i alone
Control group, administration of the phosphodiesterase 5 inhibitor PDE5i, as per clinical practice
Related Therapeutic Areas
Sponsors
Leads: Regina Elena Cancer Institute