NCT04720755

Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center · Federal
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Low-intensity extracorporeal shock wave therapy (Li-ESWT) has shown promise as a novel treatment for erectile dysfunction (ED), though the the mechanism of action and optimal protocol for administration has not been well-established. The aim of this study is to assess for subjective and objective improvements in erectile function following treatment with Li-ESWT.

Detailed description

Eligible patients will be enrolled as outlined below. Prior to initiation of Li-ESWT treatments, patients will complete validated questionnaires to assess erectile function. In addition, patients will undergo induction of artificial erection in clinic with assessment of penile blood flow using penile Doppler. Intracavernosal pressure measurements will be obtained. A corporal aspirate will be drawn and examined for levels of neuronal nitric oxide synthase, endothelial nitric oxide synthase, brain-derived neurotropic factor and vascular endothelial growth factor. Patients will then receive twice-weekly Li-ESWT treatments of 0.2mJ/mm\^2 over 3 treatment sites along the dorsal penile shaft, 1500 shocks per treatment (500 shocks per treatment site), for a total of 3000 shocks per week, for 6 weeks of treatment (totally 18,000 shocks). Following Li-ESWT treatments, patients will complete the same validated questionnaires, penile Doppler studies, corporal aspirates and measurement of intracavernosal pressures immediately following the final Li-ESWT treatment, 4-6 weeks following completion of treatment, and again at 3 and 6 months following completion of treatment.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Low-Intensity Extracorporeal Shock Wave Therapy	Twice-weekly treatments for 6 weeks, of 0.2mL/mm\^2 administered for 500 shocks per treatment site, for a total of 3000 shocks per week.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2021-01-22
• Last updated: 2024-10-26

Locations

1 site across 1 country: United States