NCT04136288

Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

Detailed description

ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option. The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy). LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	MoreNova	Shockwave therapy delivered to the genital area with low dose shocks

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2019-10-23
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study