Penile Length Maintenance Post-Prostatectomy NCT# 03500419 July 3, 2019

Penile Length Maintenance Post-Prostatectomy

NCT# 03500419

July 3, 2019

IRB: 18-001013

Version 6.0 Revised 7/3/2019

PENILE LENGTH MAINTENANCE POST-PROSTATECTOMY

Principal Investigator [Co-Investigator(s)]

Funding Sponsor: Study Product:

Matthew Ziegelmann, MD

Landon Trost, MD Tobias Kohler, MD Josh Savage, PA-C Elise Tentis, PA-C Steve Carlson, APRN, CNP

Mayo Clinic

RestoreX?

Protocol Number: (IRBe)

Initial version: January 31, 2018 Version (1.0) Revised version: April 5, 2018 Version (2.0)

May 4, 2018 Version (3.0) November 20, 2018 Version (4.0) April 23, 2019 Version (5.0) July 3, 2019 Version (6.0)

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IRB: 18-001013

Version 6.0 Revised 7/3/2019

Table of Contents

STUDY SUMMARY ................................................................................................................................5

1 INTRODUCTION...........................................................................................................................6

1.1 BACKGROUND............................................................................................................................................. 6

1.2 INVESTIGATIONAL DEVICE.......................................................................................................................... 6

1.3 PRELIMINARY DATA ................................................................................................................................... 7

1.4

STUDY RATIONALE AND RISK ANALYSIS (RISKS TO BENEFITS RATIO)....................................................... 7

1.4.1 Study Rationale....................................................................................................................7

1.4.2 Potential Benefits.................................................................................................................7

1.5

ANTICIPATED DURATION OF THE CLINICAL INVESTIGATION....................................................................... 8

2 STUDY OBJECTIVES....................................................................................................................8

2.1 PRIMARY OBJECTIVE .................................................................................................................................. 8 2.2 SECONDARY OBJECTIVE ............................................................................................................................. 8

3 STUDY DESIGN.............................................................................................................................8

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 ENROLLMENT ...................................................................................................................... 9 3.5 STUDY SCHEMA ........................................................................................................................................ 10 3.6 RANDOMIZATION PROTOCOL .................................................................................................................... 11

4 STUDY PROCEDURES............................................................................................................... 11

4.1 PRE-OPERATIVE ASSESSMENTS ................................................................................................................ 11 4.2 BASELINE ASSESSMENT ............................................................................................................................ 11 4.3 6 MONTH VISIT ......................................................................................................................................... 12 4.4 9 MONTH VISIT ......................................................................................................................................... 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 ....................................................................................................... 15

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

8 STUDY FINANCES ..................................................................................................................... 18

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IRB: 18-001013

Version 6.0 Revised 7/3/2019

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 ............................................................................................................................ 19

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IRB: 18-001013

AE HIPAA PTT PD RCT

Version 6.0 Revised 7/3/2019

LIST OF ABBREVIATIONS

Adverse Event/Adverse Experience Health Insurance Portability and Accountability Act Penile traction therapy Peyronie's Disease Randomized controlled trial

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