NCT03308409

Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Boston Medical Group · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The patients with primary erectile dysfunction (IIEF-EF \<26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	Low-intensity extracorporeal shock wave therapy (Li-ESWT)	Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds. They generate a pressure pulse and transport energy as they propagate through a medium. Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity. Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue. This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.

Timeline

• Start date: 2017-10-18
• Primary completion: 2023-10-15
• Completion: 2023-10-15
• First posted: 2017-10-12
• Last updated: 2023-11-01

Locations

2 sites across 2 countries: Colombia, Mexico