NCT05646602

Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

Impact of Focused Low-intensity Shockwave Therapy (LiSWT) in Penile Disorders (Peyronie's Disease, Erectile Dysfunction, or Both), With or Without Intralesional Clostridial Collagenase (Xiaflex) Injection, Compared With Radial Shock Wave Therapy or Xiaflex Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).

Conditions

• Peyronie Disease
• Penile Curvature
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Collagenase Clostridium Histolyticum	Intralesional injection
DEVICE	Duolith SD1 T-TOP	Delivers low-intensity shockwave therapy, six sessions (once/week) of 2000 shockwaves per session with a constant energy flux density of 0.29 mJ/mm2 and frequency of 3 Hz

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-12-12
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study