Clinical and Physiological Assessment of Noninvasive Penile Afferent Vibratory Stimulation of Both Surfaces of the Penis Using the Viberect® Device in Men With Mild to Moderate ED
Phase: NA
Conditions: Organic Erectile Dysfunction
Sponsor: Johns Hopkins University

COVER PAGE 
NCT number: 01715571 
Official Title: Assessment of Penile Vibratory Stimulation 
Using the Viberect in Men with Mild-Moderate ED 
Document date: 06/12/2018 
Principal Investigator: Arthur L. Burnett 
Participating Site: Johns Hopkins University, Baltimore, 
MD, USA 
*The protocol header contains a typo and incorrectly lists the approval number as IRB00130001 instead
of the correct IRB00130002. There is no study with the approval number IRB00130001. The study has 
been closed out with the IRB and the study team is unable to submit a change in research to correct the 
typo. The study team is not permitted to make changes to an IRB-approved document so this title page 
serves to provide clarification and inform the reader that the correct IRB approval number is 
IRB00130002. The ClinicalTrials.gov record and the posted Informed Consent Form contain the correct 
IRB approval number of IRB00130002. 

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Johns Hopkins Medicine - eIRB Protocol (eForm 
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1. 
Abstract 
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Erectile dysfunction (ED) is· the inability to achieve and maintain an erection 
adequate for satisfactory sexual intercourse. ED is highly prevalent and associated with a 
significant teducti9n in both patient an1 partner quality of life. It is estimated that more than 
30-65% of men in the general popul~tion aged 40 to 80 years suffer from ED. Current 
medical treatment options for ED have ~consistent safety and efficacy prQfiles, and the total 
financial expenditure for pro-erectile m~dications is over 5 billion dollars per year. A cheap, 
easy-to-use, and effective therapy for ED would offer a significant benefit and alleviate the 
burden in men suffering from this disease process. 
Penile vibratory stimulation mirhics rapid and repetitive manual stimulation of the penis. 
Vibratory stimulation of the genitalia i
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~ considered safe by the medical community and offers 
potential benefits, such as treatment of orgasmic dysfunction, and improvement in ejaculatory 
and erectile function. Penile erection i~ controlled by spinal autonomic centers, the activity of 
which is dependent on input from s~praspinal centers and genitalia. Penile erection is a 
culmination of successful nerve reflexes that initiate a penile vascular event. By activating the 
pudendo-cavemosal reflex, vibratory stimulation of the penis at high frequency can lead to a 
reflexogenic increase in penile blood fl.ow. In addition, penile stimulation initiates a rhythmic 
contraction of the perineal muscles via the bulbocavemosus reflex, which subsequently produces 
erection rigidity. 
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The purpose of this study is tq assess the ease of us'e, safety, and patient satisfaction 
of on-demand use of the Vibere~t® device by men with mild to ·moderate erectile 
dysfunction. Thi~ research endeavor ~ill be a phase I prospective trial exploring the use of a 
hand-held vibratory device for men witµ mild-to-moderate ED. The Viberet® device is Food and 
Drug Administration (FDA) approve& for the use in men with ED, but limited studies have 
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rigorously investigated the safety and ~atient effects of this device. 
2. Study Procedures 
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This .will be a single-center, prospective, phase I clinical trial. Subjects at JHMI will be 
recruited .from the population of men ~ho visit the urology outpatient.clinics. Subjects who meet 
all. study inclusions, and do not meet !any study exclusions will be offered study participation. 
Patients will be referred to the study ba~ed on their initial clinic visit for ED consultation. We will 
not have any chart pre-screening and all the information gathered from a patient will be within the 
standard of care for their clinic consult~tion. Study eligibility will be determined from history and 
physical exam, response to validated ~rectile function questionnaires, and discussion on use of 
phosphodiesterase-5 (PDE-5) inhibitorland other medication use (dose, type, and need to obtain 
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t e patient w1s to part1c1pate, t e m1orme consent process 
' will occur in a private c!inic room and the patient will be given as much time as necessary to read 
and reflect upon the informed consent ahd all questions will be answered. No study procedures will 
be done prior to obtaining informed cobsent. 
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Those who wish to participate Lill sign an informed consent and will become familiar 
with the scope and protocol of the stud)i. They will fill out the erectile function component of the 
international index of erectile functi~n (IIEF-5), Erection Hardness Scale (EHS), Erectile 
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Dysfunction Inventory of Treatment Satisfaction (EDITS), and Treatment Satisfactions .Scale 
(TSS) questionnaires as a baseline. Patibnts will then be provided with a new Viberect stimulator 
and the manual, and will subsequently Tue instructed on the proper use of the device. Patients will 
demonstrate device use to ensure clarity with the explanation and instructions. 
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Prospective data will be collectJd from study subjects who will use the Viberect device. 
Men will be asked to perform vibratory stimulation of the penis while focused on sexual/erotic 
thoughts for approximately 7-10 minutes (depending on erectile response) for at least 3 times 
each week, at least 24 hours apart, throughout a four-week period. Men can perform the 
stimulation once daily, as long as each [session is more than 24 hours apart. Men will record the 
frequency of device use,· erectile res~onse with stimulation, and whether they were able to 
achieve sexual satisfaction, which may I include self-stimulation or penetrative intercourse. 
Participants willifill out the IIEf-5, EHS, EDITS, and TSS questionnaires on week 4. 
The answers to these validated questionnaires will be compared to baseline to evaluate patient 
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effect when using the device. The diaries will be evaluated to explore both the safety, as well 
as the patient effect when using the Vi1erect device. · 
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If study subjects decide to use PDE-5 inhibitors during the 4-week study period (not 
provided by investigators), we ask that[they record frequency of use, time, drug type, dosage, 
and commentary of sexual response as ~result separately. 
b. Study duration and number of studl visits required of research participants. 
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The total duration of subject participatipn in this study is 4 weeks. A total of 2 clinic visits will be 
included in this study. The first clinic viisit will be the baseline evaluation and explanation of the 
stUdy, and then a follow-up visit appro~dmately 4 weeks after initiation 9f study period. This 4 
week visit is standard of care visif; bas~d on physician's discretion after. starting a new 
therapeutic treatment of ED. 
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Initial visit: Perform the history and p~ysical exam. and to discuss the clinical study. Informed 
consent will be obtained at this visit if~articipant willing to proceed and meet inclusion criteria. 
Study subjects will fill out the IIEF-5, EHS, EDITS, and TSS for baseline documentation. 
Participants will receive their Vibered device, including the user manual (~ttached) and will 
receive instructions on the use of their device. Patients will do a brief demonstration of how to 
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use the device in order to ensure patient understanding and proper utilization. 
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Follow 1up visit at four weeks: This isl the standard follow-up appoint~ent to discuss efficacy and 
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safety of the stirllulator. The Viberect device is the patient's to keep, however if they are not 
interested in continuing use, then can bring the device back and it will be returned to Reflexonic 
by the team. The patient will fill out tfue IIEF-5, EHS, EDITS, and TSS forms again and will be 
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collected from the patient by nursing staff or the investigators. Patients will have a penile 
examination to document any sores, lesions, or irritation. 
Patients in this study will not be blinded, as we would not be able to blind patients to using a 
vibratory device or not, and there is ollly one treatment groupPatients in this study will not be 
compared to a non-treatment group. This is a phase I trial exploring safety of the device, and we 
therefore want all participants to use the device and provide their individual reports and feedback. 
The standard of care for men p~esenting with mild-to-mo,derate ED and requesting 
treatment are PDE5-inhibitors (Viagra,'.Levitra, Cialis). While on study, patients will be 
able to use on-demand PDE5-inhibitod as per usual. Future studies may compare Viberect 
to PDE5-inhibitors, but the present study is· exploring safety of the devic~. 
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Patients would be considered a treatment failure if they are unable to use theViberect 
device as recommended for the trial dud to either mechanical issues or inability to tolerate the 
penile sensation when using the device: : 
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Once given the Viberect device\ it will be the participants to keep. Should the patient not 
want to possess the device, the will be instructed to the device back at their follow-up 
appointment and it will be returned to the manufacturing company. Patients are able to continue 
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using the Viberect device for personal \!Se after the study is complete. Patients are still required 
to follow the instructions in regards to duration of use and technique of application. 
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Inclusion/Exclusion Criteria! 
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Inclusion criteria: 
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Men ages between 30-70 interested in treatment for erectile dysfunction 
IIEF-5 score equal to or greater
1than 13 but less than 25. 
Exclusion criteria: 
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Men with neurological disease, !including a history of spinal cord injury or trauma 
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IIEF-5 score less than 13 
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History of priapism 
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Men with a history of radical pt,ostatectomy within the past 2 years. 
Pre-existing penile skin lesionsfiulcers 
Allergy to latex 
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Inability to understand and dempnstrate device use instructions. 
Patients with insulin-dependentidiabetes who suffer peripheral neuropathy or other 
diabetes associated complicatioiis 
Patient unwilling to engage in s~xual activity 
Patient is currently participating in another clinical investigation that would serve as a 
contraindication to applying a stimulatory device to augment erectile function 
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DRUGS/SUBSTANCES/DEVICES 
The Viberect penile vibratory istimulation system is a medical device cleared by the 
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Food and Drug Administration (510J Clearance Letter attached). The FDA statement reads: 
"The Viberect is a medical device indicated to provoke erection in men who experience erectile 
dysfunction and to provoke ejaculati~n in spinal cord injured men." It is currently cleared for 
sale with, and without a doctor's presbription. 
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The Viberect is a class II medical device that is easy-to-use and when properly applied, 
stimulates the nerves of the penis, ak a form of sexual aid. In addition, the vibratory 
mechanism stimulates the spinal ner~e reflexes that are 'responsible for the initiation of penile 
erection and rigidity. The device is pbwered by a rechargeable battery. This device has two 
gentle vibrating motors that allows fJr sin{ultaneous vibratory stimulation of both surfaces of 
the penis. The dorsal and ventral sidd of the male penis is supplied by the dorsal nerve and 
perineal nerve, respectively. Simultarteous stimulation of both nerves should increase the sexual 
re~oo~. 
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b. 
Justification\and safety ,information if FDA approved drugs will be administered 
for non-FDA approved indicatiqns or if doses or routes of administration or participant 
populations are changed. NA 
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c. Justification and safety infof;mation if non-FDA approved drugs without an IND# 
will be administered NA 
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d For IND/IDE studies, a s~Jmary of preclinical and early human studies. NA 
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July 7, 2011 
Power button 
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Vibrating soft pads 
for skin contact and 
Hand Grip 
charging 
connector 
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device open 
device closed 
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5. 
STUDY STATISTICS 
a. Primary outcome variable. 
The primary outcome parameter 
safety, patient tolerability, and patient satisfaction with the 
hand-held penile vibratory systeni. 
b. Secondary outcome variables. 
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The secondary outcome paramet¢r is erectile response (erection, rigidity, orgasm) and 
subjective patient and/or partner ~exual satisfaction, when applicable: 
c. Statistical plan including sample size justification and interim data analysis. 
This is a prospective study. Descriptive statistics will be performed based on pre-treatment 
and post-treatment responses to Validated sexual function questionnaires. This data will be 
utilized to perform power analys~s to generate future studies. We will recruit a total of 20 
patients for this study. 
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d Early stopping rules. 
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Patients who stop the use ofthe
1 Viberect early, will be recorded and their reasoning will be 
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. documented. Since this is a phase I trial, patient safety and satisfaction is the primary 
outcome and therefore it will bJ essential to understand why a patient stops use 
prematurely. 
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6. 
RISKS 
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a. Medical
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risks, listing all procedures,;their major and minor risks and expected frequency. 
Definition of adverse events: Adverse events related to the use of the Viberect device include any 
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user discomfort during or after use of the device, including pain, fatigue, numbness, rash, or device 
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malfunction. 
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Potential (anticipated) adverse events 
-Pain, numbness of the peni~ or the hand holding the device 
Adverse event reporting 
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Description of adverse ~vents (see risk analysis) 
11. Serious adverse events 
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-potential serious adyerse events include device malfunction, vibrating 
pad dislodgment and vibrating tip damaging the penis . 
. iii. Unanticipated adverse d~vice effects 
- Device overheats and burns. The device will not be used while connected to 
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the electric outlet, t}ierefore.minimizing potential risk of burns or overheat 
iv. Adverse event severity/strength: To be reported immediately to senior 
investigator and principal investigator. 
v. 
Serious adverse event narratives: reports and narratives will be included 
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b. Time periods for adverse events repor~ing: 
Weekly reporting to senior and p~ncipal investigator. 
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·. 
\ Af~k. 
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Inability to correctly use the 
Viberect device according to 
User's Guide. 
Any user discomfort during or 
after use of the device, including 
pain, fatigue, numbness, rash, 
device malfunction or hand pain 
from holding the device. 
User does not respond to 
device. 
Skin irritation, tear, or 
infection 
Serious Medical Conditions 
Such as Priapism. 
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Mild 
Moderate 
Serious 
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:Mitigiti~n ·. 
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Detailed and Simplistic (with figures) instructions are 
included in the in the User's Guide. Also the manufacturer 
recommends in the User's Manual that the user perform the 
Viberect method for at least two occasions in a clinical 
setting before using at home. 
Viberect Device must not be used more than I 0 minutes per 
day with strict accordance to the User's manual. Also, manual 
includes A WARNING that states: "Vibratory stimulation 
may cause a superficial trauma to the skin resulting in 
bruising, bleeding or superficial ulceration. If any such 
condition occurs, refrain from vibrating and consult your 
physician. This device should not be used over swollen or 
inflamed areas or skin eruptions. · 
User's Guide provides direction that the Viberect may have to 
be used multiple times before it is effective. 
Not all men will responds to this treatment. 
As specified in the User's Manual, the Viberect Device should 
not be used if visible penile skin irritation (e.g., swollen or 
inflamed areas or skin eruptions). Also, User's Guide warns 
that "Vibratory stimulation may cause a superficial trauma to 
the skin resulting in bruising, bleeding or superficial 
ulceration. If any such condition occurs, refrain from vibrating 
and consult your physician." 
The device should not be used for more than I 0 
minutes a day. 
If the user develops an erection that lasts for more than four 
hours, he may have developed priapism, which is a 
medical/surgical emergency. Contact your physician 
immediately or go to the emergency room for timely 
treatment. 
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Device malfunction, vibrating 
pad dislodgment and vibrating 
tip damaging the penis. 
Device overheats and burns. 
Use of Device while Charging 
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Deviee 
malfunc\tion 
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As specified in the User's Manual the Viberect device 
should not be used over swollen or inflamed areas or skin 
eruptions. Also, the User's Guide will advise user to: D 
check the surface of the pad over-mold for any signs of 
wear/degradation and replace ifneeded; and 
D check the integrity of the pad-pad over-mold 
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· assembly. 
The circuitry/power source is electrically isolated from the 
patient's skin by thick plastic cover; that is, no circuitry or 
electrical components are exposed to the skin. In addition, no 
conductible metallic components of the device are exposed to 
the outside. 
User Manual specifies not to use the device while 
charging and connected to an electrical outlet. 
·Legal risks such as the risks that would be associated with breach of confidentiality. 
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All data collection and will be sbcured to assure confidentiality and the study database 
will be stored in encrypted database that is only available to senior and principal investigator 
or research coordinator who is responsible for data collection. 
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Financial risks to the participants. 
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There is no financial risk to the patient. The Viberect device will be provided for free to 
each participant. Clinic visits will be bi~led to the participant's insurance company as a 
consultation and a standard-of-care foll,ow-up appointment. If the participant does not have 
insurance coverage for specialist appoi~tments, they will be responsible for paying for their visits 
out-of-pocket. The study does not offerl financial compensation, however the Viberect device will 
be provided for free to the participant. I 
Steps taken to minimize the risks. 
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A comprehensive user manual will be provided to each study subject, and detailed person 
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to person instructions will be given to them prior to enrolling in the study. A demonstration will 
be provided prior to the patient using tTu.e device independently to ensure they have a full 
understanding of how to use the devicl 
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Plan for reporting adverse events unaJticipated problems or study deviations. · 
The occurrence of any serious a~verse effects Will end the patient's participation in the study 
and halt enrollment in the study to d~termine the safety of continuing. Each and every possible 
adverse effect ofViberect will be investigated and treated individually to minimize the participant's 
discomfort. The safety of having the :individual complete the study will also be assessed on an 
individual basis. At any time the parti<,;ipant can decide to terminate his participation in the study 
and no penalty or loss of benefits to wliich they are entitled. 
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7. Confidentiality 
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Paper consent forms, enrollment check sheets, and other source or study documentation will be 
kept in a study binder. This binder willibe stored in a locked office available only to the study team. 
Electronic data will be housed in a s~cure password protected database maintained by the Data 
Informatics Services Core within the J~hns Hopkins Biostatistics Center. Only the study team will 
have access to this secure database. T~ maintain the protected information of patients enrolled in 
this study, only the study Principal Investigator and primary coordinators will have the ability to 
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export data containing identifying information from this master database. For the purposes of 
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analysis, only de-identified data will b~ exported. 
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Benefits 
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i. Individual participant 
The patient's erectile functior and sexual satisfaction may improve as a result of 
participation in this study. However, th~re is no guarantee of this. The information from this research 
study may lead to a better treatment in 1the future for people with erectile dysfunction. The patients 
may not benefit from participation in this study. Their conditions may not get better or but it unlikely 
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to become worse while they are in th}s study. The study does not' offer financial compensation, 
however the Viqerect device will be pr~vided for free to the participant. 
ii. Society 
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Erectile dysfunction is a highly prevalent medical and psychological condition that affects 
millions of men worldwide and is asso9iated with a significant reduction in overall quality of life. 
The results of this study can lead to further investigations that can show the efficacy of this safe 
modality in the management of erectile) dysfunction. 
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9. Payment and Remuneration 
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The study does not offer financial compensation, however the Viberect device will be provided 
for free to the participant. 
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10. Costs 
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The Viberect device will be provided Ito patients free of charge. There are no anticipated costs 
outside of the usual standard of care for1 patients with erectile dysfunction. Participants will be seen 
routinely in clinic as a standard part of~heir care plan. If patients decide to use PDE5 inhibitors 
(such as Viagra. Cialis, or Levitra) in ac;ldition to their use ofViberect, they will be responsible for 
the cost of this drug, as per usual. 
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