Penile Lengthening Pre-Penile Prosthesis Implantation

Study Overview
=================
Brief Summary
-----------------
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.

Detailed Description
-----------------
Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously. Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (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. A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. 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. To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.

Official Title
-----------------
Penile Lengthening Pre-Penile Prosthesis Implantation

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: RestoreX
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men undergoing placement of a penile prosthesis Must be the first time a penile prosthesis is implanted Undergoing implantation of a 3-piece inflatable penile prosthesis Exclusion Criteria Prior ischemic priapism Any prior penile prosthesis surgeries Any prior penile surgeries other than circumcision Undergoing malleable penile prosthesis or Ambicor device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group 1 - Control<br>No treatment will be administered and men will not have to delay their IPP procedure | Other: Control<br>* No treatment<br>|
| Experimental: Group 2 - PTT 3x daily x 3 months<br>Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP | Device: RestoreX<br>* Penile traction therapy in the straight position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length Assessment of Penile Prosthesis Implanted | The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment) | From baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Compliance | Compare Participant compliance with traction device | From baseline to 3 months | 
| Participant Satisfaction With Traction | Compare patient reported satisfaction with use of traction device | From baseline to 3 months | 
| Adverse Events With Use of Traction | Evaluate any adverse events with use of RestoreX® for penile lengthening. | From baseline to 3 months | 
| Operative Complications | Compare intra- and/or post-operative complication rates. | 3, 6, 12 months post-operative | 
| Stretched Penile Length | Compare pre- and post-operative stretched penile lengths | From baseline to 12 months | 
| Participant Satisfaction Penile Length | Compare participant satisfaction scores including satisfaction with overall penile length | Baseline to 12 months post-operative |