Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostate… (NCT06076850) | Clinical Trial Compass
UnknownNot Applicable
Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
Malaysia70 participantsStarted 2023-07-01
Plain-language summary
Radical prostatectomy (RP) is one of the curative treatment modalities for localized or locally advanced prostate cancer. Urinary incontinence and erectile dysfunction (ED) are two most common complications after RP. Despite the advancement of prostate cancer treatment, ED post-RP remains a significant morbidity especially for patients who are sexually active pre-operatively. To improve the sexual function post-surgery, numerous strategies have been described including preservation of neurovascular bundles intra-operatively, post-operative physiotherapy, on-demand phosphodiesterase 5-inhibitors (PDE5i), regular PDE5i, intra-carvenosal injection or vacuum suction device.
Low-intensity extracorporeal shockwave therapy (LiESWT) is an emerging treatment modality of ED with promising result, and it is a well-established treatment of ED in patients with diabetes mellitus or vasculopathy. Most of the pre-clinical studies were done on post-RP ED rat models with bilateral cavernous nerve crush injury. LiESWT was observed to improve nerve-impaired ED significantly compared to sham procedures. There are currently one pilot study and one randomized controlled trial (RCT) published in the literature on this field. However, the published RCT was an open label study with no sham-controlled arm which could contribute to reporting bias and the treatment intensity might not be adequate. In our proposed study, we make a hypothesis that LiESWT and very early PDE5i can improve erectile function in patients after nerve-sparing radical prostatectomy.
Who can participate
Age range
40 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sexual Function
Timeframe: 12 months
Trial details
NCT IDNCT06076850
SponsorHospital Pengajar Universiti Putra Malaysia