NCT03843086

Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.

Detailed description

Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle. Low intensity shockwaves do not inflict pain and anesthesia or sedation is not required. This current study is a prospective, pilot, randomized, uncontrolled clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 1:1 ratio into active treatment groups. Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.

Conditions

• Vasculogenic Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction	This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2019-02-15
• Last updated: 2022-05-25