Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.

Launched by REGINA ELENA CANCER INSTITUTE · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Low Intensity Shock Wave Therapy (LiESWT) to see if it can help men recover from erectile dysfunction (ED) after undergoing robotic surgery for prostate cancer. The researchers believe that using this therapy along with a commonly prescribed medication for ED might help men regain their ability to have erections more quickly and effectively.

To be eligible for the trial, participants must be men aged 65 to 75 who have been diagnosed with low-risk prostate cancer and have undergone a type of surgery that aims to spare the nerves involved in erections. They should have had a good erectile function before surgery and must be willing to follow the study's guidelines, including completing questionnaires about their sexual health and quality of life. Participants can expect to attend follow-up appointments to evaluate their progress and complete assessments over a certain period. It's important to note that men with certain health conditions or complications from surgery are not eligible to join the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients aged ≤75 yrs;
• • Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
• • preoperative IIEF-5 score ≥ 17;
• • First PSA (45d after surgery) \<0.2
• • 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.