NCT03006536

Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Li-ESWT	Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions

Timeline

• Start date: 2017-10-01
• Primary completion: 2022-03-13
• Completion: 2022-03-13
• First posted: 2016-12-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Denmark