Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients: A Randomized, Double-Blinded, Sham-Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Malaysia
Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)
RECRUITING
Serdang
Contact Information
Primary
Vincent Khor, ChM(Urol)
khorweisheng@upm.edu.my
+603-9769 9220
Backup
Omar Fahmy, FRCS(Urol)
omarfahmy.ahmed@upm.edu.my
+603-9769 9220
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 70
Treatments
Active_comparator: Standard Care + Active LiESWT
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study.~With or without Vacuum Pump~Active LiESWT
Sham_comparator: Standard Care + Sham LiESWT
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study.~With or without Vacuum Pump~Sham LiESWT
Sponsors
Leads: Hospital Pengajar Universiti Putra Malaysia

This content was sourced from clinicaltrials.gov

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