Shockwave Therapy for Erectile Dysfunction

(REVIVE Trial)

DP
Overseen ByDr. Premal Patel, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will investigate whether low-intensity extracorporeal shockwave therapy (LiESWT) can help men recover erectile function after nerve-sparing prostate cancer surgery. Erectile dysfunction is common after this surgery, and current rehabilitation treatments mainly help manage symptoms rather than directly promoting recovery of the affected penile tissues. LiESWT is a non-invasive treatment that uses low-intensity shockwaves and may help improve blood flow and tissue recovery.

The study will include 80 men undergoing nerve-sparing radical prostatectomy. Participants will be randomly assigned to receive either standard penile rehabilitation alone or standard rehabilitation plus eight LiESWT treatments. Erectile function, urinary function, pain, and potential side effects will be assessed throughout the 36-week study period. The main goal is to determine whether adding LiESWT increases the number of men who recover normal erectile function 24 weeks after surgery. The findings may help improve penile rehabilitation and sexual health outcomes for men recovering from prostate cancer surgery.

Are You a Good Fit for This Trial?

This trial is for men who have had nerve-sparing prostate cancer surgery and are experiencing erectile dysfunction. Participants should be able to take part in standard penile rehabilitation after their surgery.

Inclusion Criteria

I am between 18 and 70 years old.
Baseline urinary function of ICIQ ≤5
I am scheduled for a nerve-sparing radical prostatectomy.
See 4 more

Exclusion Criteria

Any medical, psychological, or social condition that, in the investigators' opinion, would interfere with study participation or adherence to the protocol
My diabetes is not well controlled, with high blood sugar levels before surgery.
I have low testosterone or untreated hypogonadism.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Intensity Extracorporeal Shockwave Therapy

Trial Overview

The study compares standard penile rehabilitation alone versus the same rehab plus eight sessions of low-intensity shockwave therapy (LiESWT). Men are randomly assigned to one group or the other, and results are tracked over 36 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LiESWT + Standard of CareExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Motorcycle Ride for Dad

Collaborator

Trials
1
Recruited
2,800+