NCT06076850

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

Status unknown NA Last updated 11 October 2023

What this trial tests

NA trial testing Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active in Erectile Dysfunction Following Radical Prostatectomy in 70 participants. Status unknown.

Timeline

1 July 2023

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	Hospital Pengajar Universiti Putra Malaysia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	1 July 2023
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across Malaysia

Drugs / interventions tested

• Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
• Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham

Conditions studied

• Erectile Dysfunction Following Radical Prostatectomy — all drugs for Erectile Dysfunction Following Radical Prostatectomy →

Sponsor

Hospital Pengajar Universiti Putra Malaysia

Who can join

Adults 40 to 75, male only, with Erectile Dysfunction Following Radical Prostatectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.