Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 158
- Locations
- 2
- Primary Endpoint
- Impact of LiESWT
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Outcomes
Primary Outcomes
Impact of LiESWT
Time Frame: 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 Outcomes
- Assess how many patients reach orgasm(3 years)
- Questionnaires of Quality of life(3 years)