NCT06219785

Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.

Detailed description

Participants will be randomized to the active treatment group or the control/placebo group. All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis. Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.

Conditions

• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
DEVICE	Low-Intensity Shockwave therapy (LiSWT)	Participants will receive once-a-week LiSWT treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2024-01-23
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study