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

NCT06076850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-11

No results posted yet for this study

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

Interventions

DEVICE

Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active

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

DEVICE

Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham

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

Sponsors & Collaborators

  • Hospital Pengajar Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Vincent Khor, ChM(Urol) · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076850 on ClinicalTrials.gov