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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05756803
• Other study ID #: 21-1144
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: April 15, 2025

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Private Office	Great Neck	New York
United States	The Smith Institute for Urology	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)	Change in corporal firmness (KPa) with Low-Intensity Acoustic Shockwave Therapy (LiST)	12 Weeks