NCT05756803

Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.

Detailed description

This study will enroll men between the ages of 18 and 65 with corporal cavernosal firmness on elastography. The participants study duration is 3 months long and includes eight visits at the study center. Study visits consist of physical exam, vital signs, questionnaires, blood draws, and administration of low-intensity shockware therapy (LiST). Low intensity extracorporeal (i.e., outside the body) shockwave therapy (LiST) is a treatment that has been in use since 2010 and has become commonly used Internationally and in the United States since 2015. The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent. The study will evaluate changes in corporal cavernosal firmness and changes in penile vascular blood flow.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Low-intensity acoustic shockwave therapy	The study is being done to find out if low-intensity shockwave therapy can improve penile blood flow and restore sexual function in men with impaired erectile function.

Timeline

• Start date: 2022-01-15
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2023-03-06
• Last updated: 2023-10-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study