Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency

Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: MoreNova

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Males with erectile dysfunction (ED); Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device	Device: MoreNova; Shockwave therapy delivered to the genital area with low dose shocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Right Resistive Index	Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Change in Right Peak Systolic Velocity	Peak systolic velocity (PSV): The maximum velocity of blood flow during erection. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Change in Right Diastolic Velocity	Diastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Erection Hardness Score (EHS)	Measured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum). 0- Penis does not enlarge, 1- Penis is larger but not hard, 2- Penis is hard but not hard enough for penetration, 3- Penis is hard enough for penetration but not completely hard, or 4-Penis is completely hard and fully rigid. A lower score indicates a worse outcome. A higher score indicates a better outcome.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
International Index of Erectile Function (IIEF - EF) Questionnaire	Measured using a self-reported International Index of Erectile Function questionnaire (IIEF - EF) consisting of 6 questions regarding the participants erectile function for the past 4 weeks. The questionnaire utilizes a scale of 0 (minimum) to 5 (maximum). A lower score indicates a worse outcome. A higher score indicates a better outcome. Questions 1-2 scale: 0=No sexual activity, 1= Almost never/never, 2= A few times (much less than half the time),3= Sometimes (about half the time), 4= Most times (much more than half the time),5= Almost always/always Questions 3-4 scale: 0=Did not attempt, 1=Almost never/never, 2= A few times (much less than half the time), 3= Sometimes (about half the time), 4= Most times (much more than half the time), 5= Almost always/always Question 5 scale:0=Did not attempt intercourse,1= Extremely difficult, 2=Very Difficult, 3=Difficult, 4= Slightly Difficult, 5= No Difficult Question 6 scale: 1= Very low, 2=Low, 3=Moderate, 4=High, 5= Very high	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Sexual Encounter Profile (SEP) Questionnaire	Measured using a self-reported Sexual Encounter Profile (SEP) Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Global Assessment Questionnaire	Measured using a self-reported Global Assessment Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Change in Left Peak Systolic Velocity	Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A Peak Systolic Velocity of 25-35 cm/s or higher is considered normal. This reflects the maximum velocity of blood flow during erection.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Change in Left Diastolic Velocity	Diastolic Velocity (DV) represents the velocity of left-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Left Resistive Index	Resistive Index (RI) is a measure of resistance to blood flow within the left penile arteries. Measured Left Resistive Index using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with poorer prognosis. Lower values are associated with a better prognosis.	Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gregory Broderick, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: 18-001246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes