Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency
Phase: NA
Conditions: Erectile Dysfunction
Sponsor: Mayo Clinic

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Principal Investigator:   Gregory Broderick, MD 
 
Study 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 
 
Protocol version number and date: 
September 10, 2019 V 2.2 
 
 
The objective of this study is to evaluate the efficacy of low intensity shockwave therapy (LiSWT) via 
MoreNova in the treatment of erectile dysfunction (ED). 
 
Aim 1: To assess the efficacy of the use of MoreNova shockwave therapy in individuals diagnosed with ED by 
a change in evidence based imagining via Color Duplex Doppler Ultrasound (CDDU) 
 
Aim 2: To evaluate the efficacy of the use of MoreNova shockwave therapy based on patient reports erectile 
charges through the IIEF-EF, EHS, SEP 2+3, and GAQ questionnaires (1, 3). 
 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.): 
 
ED is broadly defined as the inability to achieve or maintain an erection sufficient for penetration (NIH 
Consensus Statement 1992). 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, 
empirically offering therapy beginning with the least invasive treatment option. Our approach at Mayo Clinic 
Florida has been to investigate the complaint of ED in men who fail the first step in ED management which is 
a trial of oral phosphodiesterase type-5 inhibitors (PDE5I). Using evidence-based technology we rule out 
psychologic ED and characterize vascular erectile function. Color Duplex Doppler Ultrasound (CDDU) in 
combination with an age specific dosage of intracavernous vasoactive medication (alprostadil, PGE1) 
stimulates erection for office testing.  We have been able to categorize the severity of ED and identify the 
etiology of ED as arteriogenic ED, veno-occlusive ED or psychogenic ED. CDDU has become the standard of 
care in the evaluation of vascular erectile dysfunction (2). Penile injection therapy is often taught to men who 
have failed oral PDE-Type 5 Inhibitors (sildenafil, vardenafil, tadalafil). These therapies do not cure ED; they 
manage ED with escalating dosages of vasoactive drugs. 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. 
 
The present study proposal uses a device called MoreNova, in which shockwaves are focused onto linear 
IRB Minimal Risk Protocol Template 
General Study Information 
Research Question and Aims 

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segments for improved organ coverage. Shockwaves produced by MoreNova are aimed at the penile shaft 
targeting the left and right corpora cavernosa and the crura. Our study is designed to identify immediate 
effects and short term durability of

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LISWT as a non-pharmacologic, non-surgical means of treating erectile dysfunction secondary to mild ED. 
 
 
Methods: Describe, in detail, the research activities that will be conducted under this protocol: 
APPROACH 
This is prospective, pilot clinical study of 10 men aimed to evaluate the efficacy of MoreNova Shockwave therapy 
for men diagnosed with ED. We will restrict our target population to include men only between and including the 
ages of 40 and 55 who have been diagnosed with ED for over a year, but less than 5 years. 
 
Efficacy is to be assessed by CDDU imaging during and from treatment up to follow-ups. 
 
Efficacy is to be assessed by patient reported questionnaires data via IIEF-EF, SEP 2+3, GAQ and EHS that 
catalog the frequency of successful erections and side effects during treatment. 
 
RECRUITMENT 
 
Review of clinic patient records within the MCF Department of Urology to identify potential research participants 
(patients with ED who have already presented to MCF and had initial evaluation and CDDU diagnosis). 
Participants will first be identified through the treating physician and the PI on this proposal, Dr. Gregory 
Broderick. The study coordinator will then be notified of the potentially eligible patient who will further screen 
for eligibility. Once the patient has been determined eligible, the study coordinator will contact the potential study 
participant to schedule a research appointment to discuss the study in detail. The study coordinator will meet with 
the patient, describe the goals of the study, and ask if they would like to participate. If the patient agrees to 
participate at this time, a signed Patient Informed Consent is obtained before the patient leaves. The patient can 
decide at a later date to sign Informed Consent. If so, the study coordinator will schedule an appointment at a time 
when the patient will return for an appointment with a consultant. Recruitment will take place in quiet room where 
the study will be explained fully and the patient will have adequate time to decide. If a patient declines consent, 
the study coordinator will express that this in no way affects their current or future medical care. 
 
Given the paperless initiative put forth by the clinical studies units, this study will utilize the Research Participant 
Tracking (PTrax) digital signature capture feature. 
 
PARTICIPATION 
 
Once consented, the participants’ medical history will be reported and a physical examination will be performed 
as part of standard of care. Participants will be asked to stop all PDE-5 inhibitors or injectable vascular stimulants 
for 1 week prior to first treatment (washout period) and throughout the treatments. The participant will then be 
scheduled to receive their first shock wave therapy via the MoreNova device. Participants will receive a total of 
6 treatments lasting approximately 20 minutes each, two treatments weekly for 3 weeks.  A CDDU diagnostic 
will
Study Design and Methods 

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be reviewed in clinical records (within 12 months prior to study enrollment). CDDU will be repeated as part of the 
study at the final treatment and at the 3-4-month follow-up. Below is test schedule for study participants. 
 
Baseline 
Treatment 
1-5 
Treatment 6 
Follow-Up 
1 month 
Follow-up 
3-4 month 
Level 4 Evaluation/Consult 
H&E 
Xa 
Return Physical 
(Level 2 Return) 
X 
X 
Washout period 
Xb 
X 
X 
MoreNova Therapy 
X 
X 
Color Duplex Doppler 
Ultrasound (CDDU) Exam 
Xa 
X 
 
 
X 
Questionnairesc 
Xa 
Xa 
Xa 
Xa 
Adverse Events 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
astandard of care 
bBegin one-week prior to treatment 1 
cIIEF-EF,  EHS, SEP 2+3, and GAQ 
 
DATA COLLECTION 
 
Clinical data will be collected begin at time of consent from the patients’ medical record as well as the 
administered questionnaires. All data obtained for this investigation will be entered and maintained into electronic 
case report forms via REDCap database. Clinical data collection will include subject demographics (age, gender, 
race/ethnicity), current medications, and medical history relevant to cancer risk such as smoking history, body 
mass index, and family history of cancer. In addition, we will collect clinically variables resulting from the CDDU 
exam (see primary endpoint). The participant questionnaire responses will also be entered. Follow-up data 
collection for outcomes on all participants will be performed at 3-4 months after the last treatment was given. 
 
All data will be entered by approved study staff. Continuous data queries will be performed to ensure data integrity 
and completion. 
 
Resources: Describe the available resources to conduct the research (personnel, time, facilities, mentor 
commitment, etc.): This proposal will require collaborative efforts between the Department of Urology and 
Clinical Studies Unit. For this proposal we will utilize the existing research infrastructure nestled within the 
Department of Urology. A clinical research coordinator will assist in screening, consenting, and enrollment and 
follow-up data and AE collection for all participating patients. Our Urology Senior Program Coordinator  
will

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provide oversight and management to ensure timely and on budget study completion. Staff from the Urology 
Department will administer MoreNova shockwave therapy. 
 
FUNDING 
For this proposal we are requesting funding through the Florida Comprehensive Focus Research Team for a   
total of $36,969.60. Below is a breakdown of the approximated expected costs. 
 
- 
Color Duplex  Doppler Ultrasound  (CDDU):  ~$728.48  per exam  x  2 research  exams per participant= 
$1,456.92 per participant x 10 total enrolled= $14,569.60 
- 
Return Level 3 Office Visit: ~$250 per visit x 6 visits= $750.00 per participant x 10 total enrollment= 
$7,500 
- 
Clinical Research Coordinator (CCRC) .10 FTE for 1.5 years= ~ $10,016 
- 
Clinical Research Assistant .10 FTE for 1.5 years= ~$4,884 
 
To note, these are estimated costs and may not be reflective of true coordinator and data entry support. 
 
 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources. 
 
Target accrual: 10 
 
Subject population (children, adults, groups): Participants will be men only requiring treatment for ED and 
following the inclusion/exclusion criteria below. 
 
Inclusion Criteria: 
1. The patient must have given his informed and signed written consent 
2. The patient is a male 
3. Between 40 to and including 55 years of age 
4. The patient has ED for longer than 1 year but less than 5 years. 
5. The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect 
of the maximal dosage of PDE5i 
6.  IIEF-EF Domain score of 17-20 
7. Evidence Based Criteria: Doppler Clinical Exam  
 
Exclusion Criteria: 
1. The patient is participating in another study that may interfere with the results or conclusions of this 
study 
2. History of radical prostatectomy or extensive pelvic surgery 
3. Past radiation therapy of the pelvic region within 12 months prior to enrollment 
4. Recovering from cancer within 12 months prior to enrollment 
5. Neurological disease which effects erectile function 
6. Psychiatric disease which effects erectile function 
Subject Information 

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Minimal Risk Protocol Template [IRB 10429.009] 
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7. The patient is taking blood thinners 
8. History of Diabetes Mellitus 
9. History of Coronary Artery Disease 
10. Evidence Based Criteria: Doppler Clinical Exam  
11. Severe erectile dysfunction with IIEF-EF domain score < 16 
 
 
 
Check all that apply and complete the appropriate sections as instructed. 
 
1.   
  Drug & Device: Drugs for which an investigational new drug application is not required. Device for 
which (i) an investigational device exemption application is not required; or the medical device is 
cleared/approved for marketing and being used in accordance with its cleared/approved labeling. (Specify in 
the Methods section) 
 
2.        Blood:  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. 
 
3.        Biological specimens other than blood: Prospective collection of human biological specimens by 
noninvasive means that may include: urine, sweat, saliva, buccal scraping, oral/anal/vaginal swab, sputum, 
hair and nail clippings, etc. 
 
4.   
  Tests & Procedures: Collection of data through noninvasive tests and procedures routinely employed 
in clinical practice that may include: MRI, surface EEG, echo, ultrasound, moderate exercise, muscular 
strength & flexibility testing, biometrics, cognition testing, eye exam, etc.  (Specify in the Methods section) 
 
5.   
  Data (medical record, images, or specimens): Research involving use of existing and/or prospectively 
collected data. 
 
6.       Digital Record: Collection of electronic data from voice, video, digital, or image recording. (Specify in 
the Methods section) 
 
7.        Survey, Interview, Focus Group: Research on individual or group characteristics or behavior, survey, 
interview, oral history, focus group, program evaluation, etc.  (Specify in the Methods section) 
 
 
NIH has issued a Certificate of Confidentiality (COC). When checked, provide the institution and 
investigator named on the COC and explain why one was requested.   
 
 
 
For review of existing data: provide a date range or an end date for when the data was generated. The end date 
can be the date this application was submitted to the IRB. Example: 01/01/1999 to 12/31/2015 or all records 
through mm/dd/yyyy. 
Research Activity 
Review of medical records, images, specimens – Category 5 

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Date Range: Prospective Pilot Investigation 
 
Protected health information is medical data that can be linked to the subject directly or through a combination 
of indirect identifiers. 
 
Recording identifiers (including a code) during the conduct of the study allows you to return to the medical 
record or data source to delete duplicate subjects, check a missing or questionable entry, add new data points, 
etc. De-identified data is medical information that has been stripped of all HIPAA identifiers so that it cannot be 
linked back to the subject. De-identified data is rarely used in the conduct of a research study involving a chart 
review. 
 
Review the list of subject identifiers below and, if applicable, check the box next to each HIPAA identifier 
being recorded at the time of data collection or abstraction. Identifiers apply to any subject enrolled in the 
study including Mayo Clinic staff, patients and their relatives and household members. 
 
Internal refers to the subject’s identifier that will be recorded at Mayo Clinic by the study staff. 
External refers to the subject’s identifier that will be shared outside of Mayo Clinic. 
 
Check all that apply: 
INTERNAL 
EXTERNAL 
Name 
X 
Mayo Clinic medical record or patient registration number, lab accession, 
specimen or radiologic image number 
X 
Subject ID, subject code or any other person-specific unique identifying 
number, characteristic or code that can link the subject to their medical data 
X 
Dates: All elements of dates [month, day, and year] directly related to an 
individual, their birth date, date of death, date of diagnosis, etc. 
Note: Recording a year only is not a unique identifier. 
X 
Social Security number 
Medical device identifiers and serial numbers 
Biometric identifiers, including finger and voice prints, full face photographic 
images and any comparable images 
Web Universal Resource Locators (URLs), Internet Protocol (IP) address 
numbers, email address 
Street address, city, county, precinct, zip code, and their equivalent geocodes 
Phone or fax numbers 
Account, member, certificate or professional license numbers, health 
beneficiary numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Check ‘None’ when none of the identifiers listed above will be recorded, 
maintained, or shared during the conduct of this study.  (exempt category 4) 
None 
  None 
 
 
HIPAA Identifiers and Protected Health Information (PHI) 
Data Analysis 

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Power analyses and study endpoints are not required for minimal risk research, pilot, nor feasibility studies. 
 
This investigation is a pilot study to determine the efficacy of the shockwave therapy MoreNova for patients 
with ED and as such, no previous formal power calculations were completed. 
 
Primary Endpoint: 
- 
To assess efficacy for patients receiving MoreNova therapy for treatment of ED via CDDU exam. To 
provide and evidence basis for improved of ED, we will closely monitor the 10 patients enrolled in the 
study. By including CDDU imaging done as part of patient’s clinical assessment in PI’s standard clinical 
practice, at time of last protocol treatment, and at 3-4 month follow-up, we will have evidence based data 
for improvement of erectile function. Specifically, we will measure cavernosal artery inflow, peak systolic 
velocity, end diastolic velocity, resistive index and erection hardness (EHS). CDDU is performed in 
privacy with Male Nurse provider recording Doppler data and PI performing ultrasound. Patients receive 
an intracavernous injection of alprostadil (10 mcg, standard of care). CDDU measurements are taken at 
5-10 minutes and again after a period of privacy and visual sexual self-stimulation.  
 
Secondary Endpoint: 
- 
To assess efficacy for patients receiving MoreNova therapy for treatment of ED via IIEF-EF, Total IIEF-
EF, EHS, SEP 2+3, and GAQ questionnaires. To provide clinical and participant self-reported date, we 
will administer questionnaires at baseline, after the last treatment, and at the 1 and 3-4 month follow-up. 
Specifically, these questionnaires target sexual and erectile function as well as quality of life. 
 
 
 
 
 
References: 
 
1. R. Rosen, A. Riley, G. Wagner, I. Osterloh, J. Kirkpatrick, A. Mishra, The International Index of Erectile 
Function (IIEF): A Multidimensional Scale for Assessment of Erectile Dysfunction. Urology 49: 822-830 
(1997)  
2. T. LeRoy, G. Broderick, Doppler Blood Flow Analysis of Erectile Function: Who, When, and How. Urol 
Clin N Am 38 (2011) 147-154 
3. Mullhall JP, Levine LA, Junemann KP, Erection hardness: a unifying factor for defining response in the 
treatment of erectile dysfunction.  Urology 2006 Sep;  vol 68 (issue 3 suppl) : 17-25