Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Recruiting · NCT06717711 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)PDE5 inhibitor (tadalafil)
What this trial is about
This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
Who can take part
Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients aged ≤75 yrs;
- PSA \<10 ng/mL
- Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- undergoing nerve sparing RARP;
- preoperative IIEF-5 score ≥ 17;
- First PSA (45d after surgery) \<0.1
- Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology
- ≥ 18 yrs old;
- 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
Where it is running
2 locations listed.
- IRCCS "Fondazione G. Pascale" National Cancer Institute - Naples, Italy
- IRCCS "Regina Elena" National Cancer Institute - Rome, RM, Italy