Back to resultsChanges in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
Primary Purpose
Erectile Dysfunction
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-intensity acoustic shockwave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Private Office
- The Smith Institute for Urology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Intensity Acoustic Shockwave Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05756803
Brief Title
Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
Official Title
Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Intensity Acoustic Shockwave Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low-intensity acoustic shockwave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)
Description
Change in corporal firmness (KPa) with Low-Intensity Acoustic Shockwave Therapy (LiST)
Time Frame
12 Weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men aged 18-64
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Private Office
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
The Smith Institute for Urology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
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