Penile Lengthening Pre-Penile Prosthesis Implantation

Recruiting now · Not applicable

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT07053826

Run by

University of Pittsburgh

People needed

48

Starts

2025-08-26

Expected to finish

2027-02-01

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Mercy Hospital, Urology — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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