Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

A study testing MoreNova in people with Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 40 to 55 years, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: MoreNova
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2019to 1 Jul 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Erectile Dysfunction
Being tested: MoreNova
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MoreNovaDevice
Shockwave therapy delivered to the genital area with low dose shocks

Study groups in NCT04136288
Study group	Role	What they receive
Males with erectile dysfunction (ED)	Experimental	Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device Receives: Device: MoreNova

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20191 Jul 2023

First posted23 Oct 2019
Study start1 Dec 2019
Primary completion1 Jul 2023
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04136288
Sponsor's protocol ID: 18-001246
Status last verified: Oct 2024
First submitted: 21 Oct 2019
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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