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

NCT06076850 | Unknown DMC

• 1 other identifier: JKEUPM-2023-073
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Sexual Function

  Measurement of average change in IIEF-5 score from baseline (pre-RP) to specified time-points at 1,3,6 and 12 months after completion of treatment - 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome

  12 months

Secondary Outcomes (3)

• Stretched Penile Length

  12 months

• Urinary Function

  12 months

• Safety and Adverse Events

  12 months

Study Arms (2)

Standard Care + Active LiESWT

ACTIVE COMPARATOR

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

Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active

Standard Care + Sham LiESWT

SHAM COMPARATOR

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

Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham

Interventions

Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active DEVICE

Treatment protocol: * EFD 0.096 mJ/mm2 * 2 sessions / week; 5000 shocks / session * 6 weeks treatment * total: 12 sessions * Li-ESWT to start after removal of indwelling catheter

Also known as: Dornier Aries 2 (Dornier MedTech, Germany)

Standard Care + Active LiESWT

Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham DEVICE

Treatment protocol: * EFD 0 mJ/mm2 * 2 sessions / week; 5000 shocks / session * 6 weeks treatment * total: 12 sessions * Li-ESWT to start after removal of indwelling catheter

Also known as: Dornier Aries 2 (Dornier MedTech, Germany)

Standard Care + Sham LiESWT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Male patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Pengajar Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)

Serdang, Selangor, 43400, Malaysia

RECRUITING

Study Officials

• Vincent Khor, ChM(Urol)

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Khor, ChM(Urol)

CONTACT

+603-9769 9220; khorweisheng@upm.edu.my

Omar Fahmy, FRCS(Urol)

CONTACT

+603-9769 9220; omarfahmy.ahmed@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: October 11, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)