Erectile DysfunctionNCT04136288
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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Broderick, Mayo Clinic
- Investigators
- Gregory Broderick, MD, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04136288
- Acronym / sponsor ID
- 18-001246
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males with erectile dysfunction (ED) | Experimental | Device: MoreNovaMales diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoreNovaShockwave therapy delivered to the genital area with low dose shocks | Device | Males with erectile dysfunction (ED) |
Primary outcome
Change in Right Resistive Index
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Change in Right Peak Systolic Velocity
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Change in Right Diastolic Velocity
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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
Erection Hardness Score (EHS)
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
International Index of Erectile Function (IIEF - EF) Questionnaire
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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
Sexual Encounter Profile (SEP) Questionnaire
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Global Assessment Questionnaire
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Change in Left Peak Systolic Velocity
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Change in Left Diastolic Velocity
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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
Left Resistive Index
Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Broderick, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoreNova in people with Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Right Resistive Index (time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.