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

RecruitingPhase 3Ages 18 Years - 75 YearsMaleRegina Elena Cancer Institute
NCT06717711 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
  • PDE5 inhibitor (tadalafil)
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Where

2 sites
IRCCS "Regina Elena" National Cancer Institute
Rome, Italy
IRCCS "Fondazione G. Pascale" National Cancer Institute
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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