Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07053826

Penile Lengthening Pre-Penile Prosthesis Implantation

Led by University of Pittsburgh · Updated on 2025-09-05

48

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

P

Pathright Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.

CONDITIONS

Official Title

Penile Lengthening Pre-Penile Prosthesis Implantation

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a documented diagnosis of erectile dysfunction
  • Can provide informed consent
  • Are willing and able to comply with study procedures and visit schedules
  • Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis
Not Eligible

You will not qualify if you...

  • Prior ischemic priapism
  • Prior implantation of a penile prosthesis
  • Prior use of any penile traction device
  • Any prior penile surgeries other than circumcision
  • Prior pelvic radiation
  • Current or prior androgen deprivation therapy
  • Active genital infection
  • History of neophallus creation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UPMC Mercy Hospital, Urology

Pittsburgh, Pennsylvania, United States, 15219

Actively Recruiting

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Research Team

R

Roger D Klein, MD, PhD

CONTACT

M

Michelle Lucas, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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