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Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MoreNova
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given his informed and signed written consent
  • The patient is a male
  • Between 40 to and including 55 years of age
  • The patient has ED for longer than 1 year but less than 5 years.
  • The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
  • IIEF-EF Domain score of 17-20
  • Evidence Based Criteria: Doppler Clinical Exam

Exclusion Criteria:

  • The patient is participating in another study that may interfere with the results or conclusions of this study
  • History of radical prostatectomy or extensive pelvic surgery
  • Past radiation therapy of the pelvic region within 12 months prior to enrollment
  • Recovering from cancer within 12 months prior to enrollment
  • Neurological disease which effects erectile function
  • Psychiatric disease which effects erectile function
  • The patient is taking blood thinners
  • History of Diabetes Mellitus
  • History of Coronary Artery Disease
  • Evidence Based Criteria: Doppler Clinical Exam
  • Severe erectile dysfunction with IIEF-EF domain score < 16

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Males with erectile dysfunction (ED)

Arm Description

Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device

Outcomes

Primary Outcome Measures

Change in cavernosal artery inflow
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Change in peak systolic velocity
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Change in diastolic velocity
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Change in erection hardness
Measured using a self-reported erection hardness score (EHS) using a scale of 0 is penis does not change and 4 is penis is completely hard and fully rigid

Secondary Outcome Measures

Full Information

First Posted
October 21, 2019
Last Updated
August 14, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04136288
Brief Title
Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Official Title
Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).
Detailed Description
ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option. The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy). LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.

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
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Males with erectile dysfunction (ED)
Arm Type
Experimental
Arm Description
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
Intervention Type
Device
Intervention Name(s)
MoreNova
Intervention Description
Shockwave therapy delivered to the genital area with low dose shocks
Primary Outcome Measure Information:
Title
Change in cavernosal artery inflow
Description
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Time Frame
Baseline, treatment 6, 3-4 month follow up
Title
Change in peak systolic velocity
Description
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Time Frame
Baseline, treatment 6, 3-4 month follow up
Title
Change in diastolic velocity
Description
Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Time Frame
Baseline, treatment 6, 3-4 month follow up
Title
Change in erection hardness
Description
Measured using a self-reported erection hardness score (EHS) using a scale of 0 is penis does not change and 4 is penis is completely hard and fully rigid
Time Frame
Baseline, treatment 6, 1 month follow up, 3-4 month follow up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given his informed and signed written consent The patient is a male Between 40 to and including 55 years of age The patient has ED for longer than 1 year but less than 5 years. The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i IIEF-EF Domain score of 17-20 Evidence Based Criteria: Doppler Clinical Exam Exclusion Criteria: The patient is participating in another study that may interfere with the results or conclusions of this study History of radical prostatectomy or extensive pelvic surgery Past radiation therapy of the pelvic region within 12 months prior to enrollment Recovering from cancer within 12 months prior to enrollment Neurological disease which effects erectile function Psychiatric disease which effects erectile function The patient is taking blood thinners History of Diabetes Mellitus History of Coronary Artery Disease Evidence Based Criteria: Doppler Clinical Exam Severe erectile dysfunction with IIEF-EF domain score < 16
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Broderick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

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