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

NCT05756803 | Unknown DMC FDA Device

• 1 other identifier: 21-1144
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Low Intensity Acoustic Shockwave Therapy

EXPERIMENTAL

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.

Device: Low-intensity acoustic shockwave therapy

Interventions

Low-intensity acoustic shockwave therapy DEVICE

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.

Low Intensity Acoustic Shockwave Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Men aged 18-64
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Private Office

Great Neck, New York, 11021, United States

Location

The Smith Institute for Urology

Lake Success, New York, 11042, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: March 6, 2023
• Study Start: January 15, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (2)