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Recruiting Phase 3

Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

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About this study

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.

Condition
Prostate Carcinoma, Erectile Function, Genito Urinary Cancer
Tested
Low-intensity Extracorporeal Shock Wave Therapy (LiESWT), PDE5 inhibitor (tadalafil)
Sponsor
Regina Elena Cancer Institute

Who can join

Age
18 to 75 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Eligible sex: Male
  • Study condition: Prostate Carcinoma, Erectile Function, Genito Urinary Cancer
  • 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 4

  • 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

2 sites, 2 recruiting

IRCCS "Fondazione G. Pascale" National Cancer Institute

Naples, Italy

Recruiting

IRCCS "Regina Elena" National Cancer Institute

Rome, RM, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.