Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients

Launched by HOSPITAL PENGAJAR UNIVERSITI PUTRA MALAYSIA · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called low-intensity extracorporeal shockwave therapy (LiESWT) to help men who are experiencing erectile dysfunction (ED) after having a radical prostatectomy, which is surgery to remove the prostate due to cancer. The goal is to see if this therapy, combined with early use of a common ED medication, can improve sexual function in men who have had nerve-sparing surgery. This study is particularly aimed at men who had low to intermediate-risk prostate cancer and were sexually active before surgery.

To participate in this trial, men need to have undergone nerve-sparing radical prostatectomy and have a certain level of erectile function, even if they require some assistance. Some men may not be eligible if they have certain medical conditions, previous surgeries, or complications that could affect their safety or the therapy's effectiveness. Participants will receive the LiESWT treatment and can expect regular follow-ups to monitor their progress. This study is currently recruiting, and it offers a potential new option for improving quality of life after prostate surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients who underwent radical prostatectomy (open, laparoscopic or robotic-assisted) with nerve-sparing (unilateral or bilateral).
• • Low / intermediate-risk prostate cancer
• • PSA \< 20 ng/ml
• • Gleason score \< 8
• • Prostate cancer pathological stage \</= T2b
• • Sexually active with IIEF-5 score 3 18, with or without use of erectogenic aid / PDE5i.
• Exclusion Criteria:
• • Tumour upstaging beyond T2b
• • Neurovascular bundle tissues bilaterally in the histopathological report.
• • Scheduled treatment with pelvic radiotherapy and / or androgen deprivation therapy post-RP.
• • Men with ED of neuropathological, endocrine or psychogenic origin.
• • Previous pelvic surgery or radiation therapy.
• • Patients with uncontrolled psychiatric conditions.
• • Patients with major post-operative complications that could impact safety or effectiveness of ESWT.
• • Patients with heart disease - unable to take PDE5i or prohibited from sexual activity.
• • Patients on anticoagulation / antiplatelets except aspirin up to 100mg daily.
• • Inflammation in the shockwave area or having penile pathology such as Peyronie's disease.