NCT06152146

Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Shockwave Therapy	Each therapy session will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base)
OTHER	SHAM shockwave therapy	Each therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base)

Timeline

• Start date: 2024-07-08
• Primary completion: 2025-12-15
• Completion: 2026-06-01
• First posted: 2023-11-30
• Last updated: 2024-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study