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

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Device: Low-intensity acoustic shockwave therapy

• Registration Number: NCT05756803
• Lead Sponsor: Northwell Health

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-19
• Study Start: 2022-01-15
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Men aged 18-64
4. Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.

Exclusion Criteria

1. Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy
2. Presence of a penile implant.
3. Presence of cardiac pacemaker or defibrillator
4. Patients who are using devices which are sensitive to electromagnetic radiation.
5. Screening ultrasound positive for testicular cancer
6. Presence of untreated prostate cancer
7. Patients with severe coagulation disorders
8. Patient that in the opinion of the Principal Investigator would be non-compliant with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Intensity Acoustic Shockwave Therapy	Low-intensity acoustic shockwave therapy	The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent. The low-intensity shockwave therapy device will be used with the purpose of improving penile blood flow and restoring sexual function in men with impaired erectile function.

Primary Outcome Measures

Name	Time	Method
Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)	12 Weeks	Change in corporal firmness (KPa) with Low-Intensity Acoustic Shockwave Therapy (LiST)

Trial Locations

Locations (2)

Private Office; 🇺🇸 Great Neck, New York, United States

The Smith Institute for Urology; 🇺🇸 Lake Success, New York, United States