Penile Lengthening Pre-Penile Prosthesis Implantation
Phase: NA
Conditions: Erectile Dysfunction
Sponsor: Mayo Clinic

 
 
Penile Lengthening Pre-Penile 
Prosthesis Implantation  
 
NCT# 03500406 
 
October 10, 2018 

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PENILE LENGTHENING PRE-PENILE PROSTHESIS 
IMPLANTATION 
 
 
 
Principal Investigator 
 
[Co-Investigator(s)] 
Landon Trost, MD 
 
Arnold Bullock, MD 
Tobias Kohler, MD 
Josh Savage, PA-C 
Elise Tentis, PA-C 
Steve Carlson, APRN, CNP 
 
Funding Sponsor: 
 
Mayo Clinic 
Study Product: 
RestoreX® 
Protocol Number: (IRBe) 
17-011052 
 
 
 
 
 
Initial version: January 5, 2018 Version (1.0)  
Revised: 
March 15, 2018 Version (2.0) 
Revised: 
April 6, 2018 (3.0) 
Revised: 
May 15, 2018 (4.0) 
Revised: 
October 10, 2018 (5.0) 
 
 

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Table of Contents 
STUDY SUMMARY ................................................................................................................................5 
1 
INTRODUCTION ...........................................................................................................................6 
1.1 
BACKGROUND ............................................................................................................................................. 6 
1.2 
INVESTIGATIONAL DEVICE .......................................................................................................................... 7 
1.3 
PRELIMINARY DATA ................................................................................................................................... 7 
1.4 
STUDY RATIONALE AND RISK ANALYSIS (RISKS TO BENEFITS RATIO) ....................................................... 8 
1.4.1 
Study Rationale ....................................................................................................................8 
1.4.2 
Potential Benefits .................................................................................................................8 
1.5 
ANTICIPATED DURATION OF THE CLINICAL INVESTIGATION ....................................................................... 8 
2 
STUDY OBJECTIVES ....................................................................................................................8 
2.1 
PRIMARY OBJECTIVE .................................................................................................................................. 8 
2.2 
SECONDARY OBJECTIVE ............................................................................................................................. 9 
3 
STUDY DESIGN .............................................................................................................................9 
3.1 
SUBJECT SELECTION ................................................................................................................................... 9 
3.1.1 
Inclusion Criteria .................................................................................................................9 
3.1.2 
Exclusion Criteria ................................................................................................................9 
3.2 
SETTING ...................................................................................................................................................... 9 
3.3 
RECRUITMENT............................................................................................................................................. 9 
3.4 
CONSENT AND ACCRUAL .......................................................................................................................... 10 
3.5 
STUDY SCHEMA ........................................................................................................................................ 10 
3.6 
RANDOMIZATION PROTOCOL .............................................................. ERROR! BOOKMARK NOT DEFINED. 
4 
STUDY PROCEDURES............................................................................................................... 11 
4.1 
VISIT 1 - INITIAL STUDY ASSESSMENTS .................................................................................................... 11 
4.2 
FOLLOW-UP VISIT – TREATMENT PATIENT ............................................................................................... 11 
• 
QUESTIONNAIRE AFTER PENILE TRACTION, BUT BEFORE IPP SURGERY ..................................................... 11 
4.3 
INTRA-OP VARIABLES AND FOLLOW-UP VISITS ........................................................................................ 11 
4.4 
FOLLOW-UP SURVEYS – PERFORMED VIA REDCAP SURVEY OR TELEPHONE FOLLOW-UP ......................... 12 
4.5 
ASSESSMENT OF LENGTH .......................................................................................................................... 12 
4.6 
SCHEDULE OF EVENTS .............................................................................................................................. 12 
5 
STATISTICAL PLAN .................................................................................................................. 13 
5.1 
DATA HANDLING ...................................................................................................................................... 13 
5.2 
STATISTICAL ANALYSIS ............................................................................................................................ 13 
6 
SAFETY AND ADVERSE EVENTS ............................................................................................ 14 
6.1 
ADVERSE EVENT REPORTING PERIOD ....................................................................................................... 14 
6.2 
PREEXISTING CONDITION .......................................................................................................................... 15 
6.3 
POST-STUDY ADVERSE EVENT .................................................................................................................. 15 
6.4 
HOSPITALIZATION, PROLONGED HOSPITALIZATION OR SURGERY............................................................. 15 
6.5 
RECORDING OF ADVERSE EVENTS ............................................................................................................ 15 
6.6 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS .......................................... 16 
6.6.1 
Sponsor-investigator Reporting: Notifying the Mayo IRB ..................................................... 16 
6.6.2 
Stopping Rules .................................................................................................................. 16 
6.6.3 
Medical Monitoring .......................................................................................................... 17 
7 
DATA HANDLING AND RECORD KEEPING ........................................................................... 17 
7.1 
CONFIDENTIALITY..................................................................................................................................... 17 
7.2 
SOURCE DOCUMENTS................................................................................................................................ 17 
7.3 
RECORDS RETENTION ............................................................................................................................... 17 

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8 
STUDY FINANCES ..................................................................................................................... 18 
8.1 
FUNDING SOURCE ..................................................................................................................................... 18 
8.2 
CONFLICT OF INTEREST ............................................................................................................................. 18 
8.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................................ 18 
8.4 
REGULATORY INFORMATION .................................................................................................................... 18 
9 
REFERENCES ............................................................................................................................ 18 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
AE 
Adverse Event/Adverse Experience 
ED 
Erectile Dysfunction  
HIPAA 
Health Insurance Portability and Accountability Act 
IPP 
PHI 
PP 
Inflatable penile prosthesis 
Protected health information 
Penile Prosthesis 
PTT 
Penile traction therapy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Summary 
Title 
Penile Lengthening Pre-Penile Prosthesis Implantation  
IRB Protocol 
Number 
17-011052 
Methodology 
 Open enrollment 
Overall Study 
Duration 
3 years 
Subject Participation 
Duration 
3 months 
Objectives 
Compare length of penile prosthesis inserted after traction therapy 
Number of Subjects 
 80 
Diagnosis and Main 
Inclusion Criteria 
Men undergoing placement of a penile prosthesis  
Study Device 
RestoreX®, penile traction therapy 
Duration of 
Exposure 
Subjects will use device for 30 minutes, 3 times a day 
Reference therapy 
Use of the device will be compared against a control group using no 
traction therapy 
Statistical 
Methodology 
Statistical comparisons will be made comparing total length of 
prosthesis inserted between those using and not using traction, 
stratified by baseline penile length.   
 
 
 
 
 

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1 Introduction 
 
This document is a protocol for a human research device study. This study will be carried out 
in accordance with the procedures described in this protocol, applicable United States 
government regulations and Mayo Clinic policies and procedures.  
1.1 
Background 
 
Men with erectile dysfunction (ED) refractory to conservative therapies are often 
recommended to undergo placement of an inflatable penile prosthesis (IPP).  However, one 
of the most common complaints after surgery is that the men feel that their penis is shorter 
than what it was previously.  This is likely due to one of several factors including the 
underlying disease process which resulted in loss of penile length, effects of aging on penile 
length (loss of elasticity; increased fibrosis), changes in abdominal physiology (development 
of pre-pubic fat pad that obscures the penis), and recall bias (incorrect assumptions on prior 
penile length).   
 
Several attempts have been made by investigators to optimize penile length prior to 
placement of the penile prosthesis, including adjunctive surgical maneuvers (excision of 
suprapubic fat pad, release of suspensory ligament, direct penile extension), use of injectable 
materials, and pre-operative use of penile traction therapy (PTT).  In a small pilot study of 10 
men undergoing IPP, Levine and colleagues recommended the use of the Andropenis PTT ≥2 
hours daily for 2-4 months.1  At 15 months follow-up, patients achieved a +1.6 cm increase 
compared to pre-traction stretched length, and +0.9 cm increase following penile prosthesis 
(PP).  Results from a non-validated satisfaction questionnaire demonstrated that no patients 
reported loss of length following surgery.  Unfortunately, the study did not include a control 
group, thus limiting the conclusions which may be drawn.   
 
Compared to other options, PTT offers several potential advantages in that it is minimally-
invasive, does not increase the morbidity of surgery, and has not been shown to result in any 
long-term side effects.   
 
Recently, Mayo Clinic licensed a new PTT concept to PathRight Medical, who subsequently 
developed the RestroreX PTT device.  This is classified as a Class I device, not requiring 
clinical human trials.  The purported benefits with the RestoreX device over other PTT 
systems include ability to generate constant traction, user-feedback on appropriate use, 
improved comfort, and ability to track improvements.  The device is currently utilized in 30-
minute intervals, with up to 3 sessions performed per day.   
 
Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for 
PTT, and limited amount of data available, we sought to perform a clinical trial evaluating 
the effect of PTT on increasing the total length of prosthesis which can be inserted.  We 
additionally sought to determine if PTT resulted in improved post-operative satisfaction on 
total penile length achieved.    
 

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1.2 
Investigational Device 
 
RestoreX is a PTT device developed by PathRight Medical using technology licensed from 
the Mayo Clinic.  The device is classified as class I (orthotic) and does not require clinical 
trials to prove safety or efficacy.  Mayo Clinic is currently conducting a randomized clinical 
trial to evaluate several clinically relevant factors including safety, comfort, and preference 
and to provide preliminary data on dosing and efficacy (IRB 17-001283).   
 
The device has two functional aspects.  The first is the ability to provide direct traction on the 
penis.  The second is the ability to provide counter-bending forces, to treat conditions such as 
Peyronie’s disease (bent penis).  In the current study, only the direct traction aspects of the 
device will be investigated.   
 
Men will enter into either the control arm (no treatment) or  the treatment arm and will be 
recommended to utilize the device for 30 minutes, 3 times daily for 3 months prior to 
placement of an IPP.   
 
1.3 
Preliminary Data 
 
Currently, there is a small amount of preliminary data available on the RestoreX® 
instrument.  During the developmental phase of the device, a quality improvement project 
was performed to evaluate the clamping portion.  It was determined that the clamp 
represented the most critical aspect of the device, as this was where the majority of 
discomfort occurred with other devices.  Additionally, the clamp needed to provide sufficient 
friction to allow adequate traction without having the glans of the penis dislodge from the 
device.   
 
A total of 15 patients participated in the quality improvement project and had the clamps 
applied under direct supervision for 30 minutes. After the 30 minutes, all patients reported 
0/10 pain, and only minimal transient erythema was documented by the physician.  The 
clamp was again applied, and traction forces were administered to determine if the clamp 
was able to remain intact despite stretching forces applied.  This also resulted in a successful 
outcome, with all patients able to successfully achieve a minimum required tension of 1 kg, 
with a 36% safety factor achieved before any discomfort was reported among any patient.  
During the testing, patients reported improved comfort with the use of a wrap such as gauze 
or Coban, which permitted additional traction in all patients.   
 
Very limited data are available on the efficacy of PTT in men undergoing placement of an 
IPP.  As previously noted in the introduction, a small pilot study of 10 men undergoing IPP 
demonstrated a +1.6 cm increase in penile length compared to pre-traction stretched length 
and 0% of men reporting loss of length following surgery.1  The study has several notable 
limitations including a lack of control group and use of more relevant clinical measure such 
as length of device inserted.     

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Regarding background data on the RestoreX device, currently, Mayo Clinic is conducting a 
randomized clinical trial evaluating its role in men with PD (IRB 17-001283).  Initial data are 
expected by the end of 2018.   
1.4 
Study Rationale and Risk Analysis (Risks to Benefits Ratio) 
1.4.1 Study Rationale 
 
PTT has been shown to improve penile length in several clinical scenarios, including 
following penile surgery, as a primary lengthening therapy, and in men with conditions 
which shorten the penis such as Peyronie’s disease.2  Very preliminary data suggest a 
possible role for PTT prior to placement of an IPP to optimize outcomes and address a 
common complaint of reduced penile length.1  The current study is designed to address this 
gap in the literature.   
1.4.2 Potential Benefits 
 
There are several potential benefits to using PTT prior to IPP placement.  The most notable is 
the ability to place a larger device.  As reduced penile length is a very common complaint 
post-operatively, any therapy which addresses this issue offers the potential benefit of 
enhancing overall patient satisfaction.  Perhaps more importantly though, currently there are 
several adjunctive surgical techniques which are used to increase penile length.  These often 
are very morbid procedures and may result in significant consequences including necrosis of 
the glans penis, need for additional surgeries, infections, and early device failures, among 
others.  Given the minimally-invasive nature of PTT, any data demonstrating efficacy of this 
therapy offers potential benefits over the more invasive alternatives.   
1.5 
Anticipated Duration of the Clinical Investigation 
 
The overall study will be scheduled for 3 years, to permit adequate time for enrollment and 
follow-up.  The intervention phase will include 3 months of treatment (for the treatment arm) 
and up to 1 year follow-up.   
 
2 Study Objectives 
 
2.1 
Primary Objective 
 
1. The primary objective is to assess the length of the penile prosthesis inserted into subjects 
following completion of RestoreX® traction therapy compared to control groups (no 
treatment).  
 

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2.2 
Secondary Objective 
 
1. Compare patient compliance with traction device. 
2. Compare patient reported satisfaction with use of traction device. 
3. Evaluate any adverse events (AEs) with use of RestoreX® for penile lengthening.  
4. Compare intra- and/or post-operative complication rates.  
5. Compare pre- and post-operative stretched penile lengths. 
6. Compare patient satisfaction scores including satisfaction with overall penile length. 
 
 
3 Study Design 
 
3.1 
Subject Selection 
3.1.1 Inclusion Criteria 
 
• Men undergoing placement of a penile prosthesis 
• >18 years old 
• Must be the first time a penile prosthesis is implanted 
• Undergoing implantation of a 3-piece inflatable penile prosthesis  
3.1.2 Exclusion Criteria 
 
• Prior ischemic priapism 
• Any prior penile prosthesis surgeries 
• Any prior penile surgeries other than circumcision 
• Undergoing malleable penile prosthesis or Ambicor device 
 
3.2 
Setting 
 
The current study will be conducted at both the Mayo Clinic in Rochester, MN (Department 
of Urology) and Washington University in Saint Louis, Division of Urologic Surgery.  All 
patients will be recruited from Drs. Tobias Kohler’s (Mayo Clinic) and Arnold Bullock’s 
(Washington University) clinical practices.  
 
3.3 
Recruitment  
Drs. Kohler and Bullock will identify potential participants for recruitment in the study from 
their own practice and based on the inclusion and exclusion criteria. Patients will be notified 
of the study at the time of their planned clinic visit and those who would be interested in 
proceeding with the trial will be invited to meet with a study coordinator, at which time 
details of the study itself will be reviewed. No financial incentives will be provided to 
participate in the trial; however, participants would be given a RestoreX® device at no 

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charge if assigned to the treatment group. Patients will not be charged for any visits related to 
the study, and no labs or other testing will be obtained which require payment.   
 
3.4 
Consent and Accrual 
 
During the patient’s consultation appointment, they will receive a description of the study 
and if the patient expresses interest in participating, a formal consent will be reviewed (see 
Attachment – Consent Form).  
 
If the patient successfully completes the consenting process, they will undergo initial study 
penile length assessments (described later in the protocol). Those wishing additional time to 
consider  participation may be rescheduled to a later date if desired.   
 
At  the time of consent, all participants will be assigned a study identifier, with a master list 
maintained in a password protected database (Mayo server) linking the patient to the 
identifier. A total of 40 patients will be  accrued into each arm of the study, for a total of 80 
patients  accrued overall.  It is estimated that 80 patients will need to be accrued in order to 
achieve a minimum of 20 subjects in each arm that will complete the study from start to 
finish.  
 
No limitations will be applied to either clinical site for enrollments, such that it is possible 
that one clinical site may enroll 100% of the patients.   
3.5 
Study Schema 
 
During the initial scheduled clinic appointment, the patient will receive a description of the 
study, and informed consent. Potential subjects will be notified about the two groups for the 
study: Treatment (PTT for 30 min 3x/day for 3 months) or No Treatment (control).  
Subjects planning to have their IPP procedure immediately and do not want to utilize traction 
therapy will be considered for the control group. Subjects who wish to wait for placement of 
IPP and are interested in utilizing traction will enter into the treatment group. Those 
consenting will receive initial study assessments and subjects who take part in the treatment 
group will be educated on how to use the device properly.  
 
Patients will then be given a baseline questionnaire to complete and, if assigned to the 
treatment group, begin using the device. Patients in the treatment arm will record a daily 
journal of their usage of the device.   
 
After 3 months (+1.5 months permitted), patients in the treatment arm will return for their 
scheduled procedure (control arm patients will undergo surgery without a 3-month delay). 
Only those who utilized the device for 3 months will be asked to complete a follow-up 
questionnaire at this time.  Patients will also be encouraged to self-report any additional 
adverse events (AE’s) that they encountered over the 3 months of using the therapy. 
 

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During surgery, data will be recorded by the surgeon to indicate type, length and approach 
taken for penile prosthesis implanted as well as any complications of penile prosthesis 
implantation. These complications may include urethral perforation, corporal perforation, 
device malfunction, bowel injury or vascular injury; all of which are standard potential 
complications of the surgery.  
 
Following surgery, patients will be seen in the clinic based on the standard routine clinical 
practice.  During these follow-up appointments, penile length measurements will be 
performed and recorded.   
 
Patients will also be sent questionnaires by email or by mail (if email not available) at 3, 6, 
and 12 months post-operatively. If a patient has not returned their questionnaire within 2 
weeks, a follow up phone call to the patient will be placed as a reminder. Alternatively, 
patients may answer the questions over the phone if that method is preferable.  
 
The subject’s clinical records will also be reviewed up to 12 months post-operation to check 
for any complications relating to the surgery including a need for revision surgery, infection 
or hospitalizations.  
 
 
4 Study Procedures 
 
4.1 
Initial Study Assessments 
 
• Objective assessments  
o Penile length – measured from pubic symphysis to glanular corona 
• Subjective questionnaires (attached) 
o IIEF-15 
o Patient Disease History 
o Device usage diary provided for treatment group 
4.2 
Follow-up Visit – Treatment Group 
 
• Questionnaire after penile traction, but before IPP surgery 
 
4.3 
Intra-op Variables and Follow-up Visits 
 
• Objective assessments (intra-operative surgery) 
o Size of penile prosthesis implanted at time of surgery 
o Approach for implantation of penile prosthesis  
o Type of penile prosthesis implanted 

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o Any intra-operative complications of penile prosthesis surgery to be recorded 
by surgeon 
• Follow-up visits - conducted per surgeon’s individual protocols.  May include one or 
more visits performed for up to 12 months after surgery.    
o Stretched penile length assessed 
o Notation of any interval complications or AEs 
 
4.4 
Follow-up Surveys – Performed via Redcap Survey, Mailer or Telephone Follow-
up 
• Performed at 3, 6, 12 months 
• Subjective questionnaires for all patients (treatment and controls) 
o IIEF-15 
o Follow-up questionnaire  
• Patients records to be reviewed 12 months post-operation to check for interval 
complications  
o Revision surgery, infection or hospitalizations 
 
4.5 
Assessment of Length 
Penile length measurements will be obtained by a member of the clinical team using a 
measurement from the pubic symphysis to the corona of the glans penis.  Measurements will 
be obtained pre-operatively and at all clinical visits post-operatively up to 12 months.   
 
Size, type and approach of penile prosthesis implanted will be recorded by surgeon on 
operative note.  
 
See Attachments – Device Usage Diary, Disease Specific History, IIEF-15, 
Questionnaire After Penile Traction but before IPP Surgery, Follow Up Questionnaire 
 
4.6 
Schedule of Events 
 
Table 1: Schedule of Events for Treatment Group 
 
Study Activity 
Baseline 
3 Month 
 
6 Month 
(3 months 
post-op) 
9 Month 
(6 months 
post-op) 
15 Month 
(12 months 
post-op) 
 
 
 
 
 
 
Consent 
X 
 
 
 
 
Baseline Questionnaire 
X 
 
 
 
 
Length Assessment 
X 
 
 
 
 
Patient Diary Provided  
X 
 
 
 
 
PTT Experience Questionnaire 
 
X 
 
 
 

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Penile Prosthesis Implanted 
 
X 
 
 
 
Penile Prosthesis Length Recorded 
 
X 
 
 
 
PP Follow-Up Questionnaire 
 
 
X 
X 
X 
Chart Review of Post-Op 
Complications 
 
 
 
 
X 
 
 
Table 2: Schedule of Events for Control Group 
 
Study Activity 
Baseline 
3 Month 
  
6 Month 
12 Month 
 
 
 
 
 
Consent 
X 
 
 
 
Baseline Questionnaire 
X 
 
 
 
Length Assessment 
X 
 
 
 
Penile Prosthesis Implanted 
X 
 
 
 
Penile Prosthesis Length Recorded 
X 
 
 
 
PP Follow-Up Questionnaire 
 
X 
X 
X 
Chart Review of Post-Op Complications 
 
 
 
X 
 
 
5 Statistical Plan 
5.1 
Data Handling 
 
All data will be recorded either by the patient themselves or by the provider directly onto 
printed forms (Attachments).  Information will remain de-identified throughout the 
remainder of the study period and will remain on password protected, Mayo servers.   
 
After completion of the study, de-identified information will be shared with individuals 
associated with PathRight Medical, Inc. who may assist with portions of the data analysis 
and/or manuscript drafting.  No identifiable information will be sent.   
 
5.2 
Statistical Analysis 
 
Analyses will be performed using comparisons within patients of same baseline penile stretch 
length and between groupings of varying lengths. Comparison of device length implanted 
will be made for subjects using the traction device compared to those who did not utilize 
traction. Comparisons will also be made on other subjective and objective variables obtained 
including number of adverse events, complications, subjective responses to questionnaires, or 
other information.  Pre- and post-operative penile lengths will also be compared within 
individuals.  All data will be normalized based on pre-operative stretched penile length.   
 

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6 Safety and Adverse Events 
 
Definition of Adverse Event 
 
Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) - any 
unanticipated problem or adverse event that meets the following three criteria:  
 
Serious: Serious problems or events that results in significant harm, (which may be physical, 
psychological, financial, social, economic, or legal) or increased risk for the subject or others 
(including individuals who are not research subjects). These include: (1) death; (2) life 
threatening adverse experience; (3) hospitalization - inpatient, new, or prolonged; (4) 
disability/incapacity - persistent or significant; (5) breach of confidentiality and (6) other 
problems, events, or new information (i.e. publications, interim findings, product labeling 
change) that in the opinion of the local investigator may adversely affect the rights, safety, or 
welfare of the subjects or others, or substantially compromise the research data, AND 
 
Unanticipated: (i.e. unexpected) problems or events are those that are not already described 
as potential risks in the protocol, consent document, not listed in the Investigator’s Brochure, 
or not part of an underlying disease. A problem or event is "unanticipated" when it was 
unforeseeable at the time of its occurrence. A problem or event is "unanticipated" when it 
occurs at an increased frequency or at an increased severity than expected, AND 
 
Related: A problem or event is "related" if it is possibly related to the research procedures. 
 
Adverse Event - an untoward or undesirable experience associated with the use of a medical 
product (i.e. drug, device, biologic) in a patient or research subject. 
 
Serious Adverse Event - adverse events are classified as serious or non-serious.  Serious 
problems/events can be well defined and include: 
 
• 
Death 
• 
Life threatening adverse experience 
• 
Hospitalization 
• 
Inpatient, new, or prolonged; disability/incapacity 
• 
And/or per protocol may be problems/events that in the opinion of the sponsor-
investigator may have adversely affected the rights, safety, or welfare of the subjects or 
others, or substantially compromised the research data. 
 
All AEs that do not meet any of the criteria for serious, should be regarded as non-serious 
AEs.  
 
6.1 
Adverse Event Reporting Period 
 
For the current study, the treatment follow-up period is defined as 3 months following 
implantation of the penile prosthesis.  

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6.2 
Preexisting Condition 
 
A preexisting condition is one that is present at the start of the study.  A preexisting condition 
should be recorded as an adverse event if the frequency, intensity, or the character of the 
condition worsens during the study period. 
 
At screening, any clinically significant abnormality should be recorded as a preexisting 
condition.  At the end of the study, any new clinically significant findings/abnormalities that 
meet the definition of an adverse event must also be recorded and documented as an adverse 
event.  
 
6.3 
Post-study Adverse Event 
 
All unresolved AEs will be followed by the study team until the events are resolved, the 
subject is lost to follow-up, or the AE is otherwise explained.  A review of AEs which the 
subject or subject’s physician believe might reasonably be related to participation in the 
study will be performed up to 12 months following surgery.   
 
6.4 
Hospitalization, Prolonged Hospitalization or Surgery 
 
Any AE related to the study intervention that results in hospitalization or surgery should be 
documented and reported as a serious AE.   
 
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as 
an adverse event in the following circumstances:  
• 
Hospitalization or prolonged hospitalization for diagnostic or elective surgical 
procedures for a preexisting condition.  Surgery should not be reported as an outcome of an 
adverse event if the purpose of the surgery was elective or diagnostic and the outcome was 
uneventful. 
 
6.5 
Recording of Adverse Events 
 
The study team will seek information on adverse events by specific questioning between 
baseline and the 3 month visit.  Information on all adverse events will be recorded 
immediately in the adverse event section of the specific questionnaire as well as in an 
adverse event form (see Attachment – Adverse Event Form). 
 
All adverse events occurring during the study period will be recorded.  The clinical course 
will be followed until resolution, stabilization, or until it has been ultimately determined that 
the study treatment or participation is not the probable cause.  Serious adverse events that are 
still ongoing at the end of the study period will be followed up, to determine the final 

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outcome.  Any serious adverse event that occurs after the study period and is considered to 
be at least possibly related to the study treatment or study participation will be recorded and 
reported immediately. 
 
6.6 
Reporting of Serious Adverse Events and Unanticipated Problems 
 
When an adverse event has been identified, the study team will take appropriated action 
necessary to protect the study participant and then complete the Adverse Event Form.  The 
sponsor-investigator will evaluate the event and determine the necessary follow-up and 
reporting required. 
 
6.6.1 Sponsor-investigator Reporting: Notifying the Mayo IRB 
 
An adverse event form will be completed for any serious adverse event.  This will be 
reported to the Mayo IRB in a de-identified manner.   
 
The study team will report to the Mayo IRB any UPIRTSOs and Non-UPIRTSOs according 
to the Mayo IRB Policy and Procedures. 
 
Information collected on the adverse event form (and entered into the research database)  
• 
Subject’s ID 
• 
Description of adverse event 
• 
The date the adverse event occurred and resolved (if applicable) 
• 
Intensity 
• 
Outcome 
• 
Action taken to address 
• 
Relationship to study 
• 
Impact on study withdrawal 
• 
Classification as serious or not 
 
The sponsor-investigator will review all adverse event reports to determine if specific reports 
need to be made to the IRB.  The sponsor-investigator will sign and date the adverse event 
report when it is reviewed.  For this protocol, only directly related SAEs/UPIRTSOs will be 
reported to the IRB. 
 
6.6.2 Stopping Rules 
 
Any serious adverse event which is determined to reasonably be related to the study device 
by the sponsor-investigator will result in immediate discontinuation of the therapy.  If 5 
patients develop serious adverse events, the study will be halted with re-review required by 
the Mayo IRB prior to consideration of study resumption.   
 

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6.6.3 Medical Monitoring 
 
Medical monitoring of serious adverse events will be performed by the study investigator on 
a monthly-basis if serious adverse events have been reported.   
 
 
7 Data Handling and Record Keeping 
7.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the 
following: 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI. 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (long term 
survival status that the subject is alive) at the end of their scheduled study period. 
7.2 
Source Documents 
 
Source data comprise all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Source data are contained in source documents.  Examples of these original documents, and 
data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after verification 
as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. When applicable, information 
recorded on the CRF shall match the Source Data recorded on the Source Documents. 
 
 
7.3 
Records Retention 
 
The sponsor-investigator will maintain records and essential documents related to the 
conduct of the study.  These will include subject case histories and regulatory documents. 
 
The sponsor-investigator will retain the specified records and reports during the study and for 
the longer of the following; 

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1. As outlined in the Mayo Clinic Research Policy Manual –“Retention of and Access to 
Research Data Policy” http://mayocontent.mayo.edu/research-policy/MSS_669717,  
 
OR 
 
2. A period of 2 years after the latter of the following two dates: The date on which the 
investigation is terminated or completed, or the date that the records are no longer 
required for purposes of supporting a premarket approval application or a notice of 
completion of a product development protocol. 
 
 
 
8 Study Finances 
8.1 
Funding Source 
This study is a Mayo Funded study.  
8.2 
Conflict of Interest 
 
Dr. Landon Trost is the inventor and developer of the RestoreX® device.  His conflict has 
previously been reviewed with the Mayo Clinic Conflict of Interest Review Board, and 
following review, it has been determined that Dr. Trost is able to conduct these studies as a 
Primary Investigator.   
8.3 
Subject Stipends or Payments 
 
Subjects will not receive payment for their participants; however, they will be able to keep 
the study device following completion of the study.  
 
8.4 
Regulatory Information 
 
PathRight Medical has registered the RestoreX® device with the FDA as a Class I device, 
similar to limb orthotics (see Attachment – RCRI Position Paper).  The device is available 
without a prescription and may be purchased by the general public.  As such, clinical studies 
are not required prior to its routine use, and the current studies are being done as an 
investigator-initiated project to determine its potential role in length of penile prosthesis 
inserted.   
 
 
 
9 References 
 

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1. 
Levine, L. A., Rybak, J.: Traction therapy for men with shortened penis prior to 
penile prosthesis implantation: a pilot study. J Sex Med, 8: 2112, 2011 
2. 
Trost, L. W., Munarriz, R., Wang, R. et al.: External Mechanical Devices and 
Vascular Surgery for Erectile Dysfunction. J Sex Med, 13: 1579, 2016