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

Launched by REGINA ELENA CANCER INSTITUTE · Nov 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment method called Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for men who have difficulty achieving erections after surgery for prostate cancer. The goal is to see if combining this therapy with a common medication for erectile dysfunction (called PDE5 inhibitors) helps men recover their ability to have erections more effectively than just using the medication alone. The researchers believe that starting this combined treatment soon after surgery may lead to better and faster recovery of erectile function.

To participate in the trial, men aged 18 to 75 who have prostate cancer and meet certain health criteria may be eligible. Key requirements include having a specific prostate cancer grade and a certain level of erectile function before surgery. Participants will receive either the combination treatment or just the medication and will be asked to complete surveys about their erectile function and quality of life. This study is currently looking for volunteers, and it aims to provide important information on how to improve recovery for men facing erectile dysfunction after prostate cancer surgery.

Gender

MALE

Eligibility criteria

• 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