Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Regina Elena Cancer Institute
158 participants
Aug 31, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria4
- 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
Interventions
Phosphodiesterase-5 (PDE5) inhibitors
LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ/mm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06717711