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 trial explores a new treatment option for men experiencing erectile dysfunction after prostate cancer surgery. It tests whether adding low-intensity extracorporeal shockwave therapy (LiESWT), a non-invasive treatment using gentle shockwaves, can improve blood flow and tissue recovery. Participants will receive either standard penile rehabilitation or the standard treatment plus LiESWT. Men who have undergone nerve-sparing prostate cancer surgery and are experiencing erectile dysfunction may be suitable candidates for this trial. The goal is to determine if LiESWT increases the chances of regaining normal erectile function 24 weeks after surgery. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance recovery and improve quality of life.

What prior data suggests that low-intensity extracorporeal shockwave therapy is safe for erectile dysfunction treatment?

Research has shown that Low-Intensity Extracorporeal Shockwave Therapy (LiESWT) is generally safe for treating erectile dysfunction. Studies indicate that patients tolerate this treatment well. For instance, a review found significant improvements in erectile function with no reported side effects. Another study observed lasting benefits in patients up to 18 months after treatment, again with no negative effects. Overall, LiESWT appears to be a safe option, with evidence suggesting it can improve blood flow and aid tissue recovery without causing harm.12345

Why are researchers excited about this trial?

Low-Intensity Extracorporeal Shockwave Therapy (LiESWT) is unique because it uses sound waves to improve blood flow, which is different from most standard treatments for erectile dysfunction like oral medications (such as Viagra or Cialis) that primarily increase blood flow temporarily. Researchers are excited about LiESWT because it targets the root cause of erectile dysfunction by promoting tissue regeneration and improving vascular function over time. This therapy could offer a longer-lasting solution without the need for daily medication. Plus, it involves a non-invasive, quick procedure that could be more convenient for many patients.

What evidence suggests that LiESWT is effective for erectile dysfunction after prostate cancer surgery?

This trial will compare low-intensity extracorporeal shockwave therapy (LiESWT) combined with standard postoperative penile rehabilitation to standard care alone. Studies have shown that LiESWT can improve erectile function, with patients experiencing an average 4-point increase in their erectile function scores. Research indicates that these benefits can last for more than six months. In some studies, up to 79% of patients noticed a significant improvement in erectile function after three months. This therapy likely works by boosting blood flow and aiding tissue recovery, both crucial for erectile function.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard postoperative penile rehabilitation with or without LiESWT. LiESWT is administered in eight sessions during postoperative weeks 3-4 and 10-11.

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for erectile function, urinary function, pain, and adverse events.

36 weeks
Multiple visits (in-person and virtual)

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+

Citations

The recommended treatment protocol for low-intensity ...

low-intensity shockwave therapy (LiST) improves vasculogenic erectile dysfunction (ED) by about 4 points based on the International Index of ...

A systematic review of the long-term efficacy of low-intensity ...

This systematic review identifies that LISWT offers a treatment modality which improves erectile function, with results lasting to over 6 months ...

Effects of Low-Intensity Extracorporeal Shockwave Therapy ...

Conclusion: In this meta-analysis of seven randomized controlled trials, treatment of ED with Li-ESWT resulted in a significant increase in IIEF-EF scores.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41200620/

Low-Intensity Extracorporeal Shock Wave Therapy (LI ...

LI-ESWT was associated with statistically significant improvements in erectile function across most studies, particularly when combined with ...

Low Intensity Shock Wave Treatment for Erectile ...

At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained ...

Effects of Low-Intensity Extracorporeal Shockwave...

In this meta-analysis of randomized controlled trials evaluating the effect of Li-ESWT on ED, the improvement in IIEF-EF scores was statistically significant ...

(PDF) Low-Intensity Extracorporeal Shock Wave Therapy ...

LI-ESWT was associated with statistically significant improvements in erectile function across most studies, particularly when combined with ...

Treatment of Erectile Dysfunction With Low-intensity ...

As a whole these studies suggest that LI-ESWT could significantly improve the IIEF-5 and Erection Hardness Score of mild ED patients. However, no randomized ...

Linear Low-Intensity Extracorporeal Shockwave Therapy ...

LI-LiESWT is a safe treatment option for penile rehabilitation, offering satisfactory results with no side effects.

Low-intensity Extracorporeal Shock Wave Treatment ...

LI-ESWT could significantly improve the IIEF and EHS of ED patients, and the patients with mild-moderate ED had better therapeutic efficacy