Penile Lengthening Pre-Penile Prosthesis Implantation

Launched by UNIVERSITY OF PITTSBURGH · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether using a device called RestoreX before surgery can help increase the size of a penile implant in men with erectile dysfunction. RestoreX is a device that gently stretches the penis and has been used safely in other groups of patients to help lengthen the penis. The study wants to see if using RestoreX before getting an inflatable penile implant can allow doctors to use a longer implant during the surgery.

Men between the ages of 65 and 74 who have been diagnosed with erectile dysfunction and are planning to have a penile implant surgery may be eligible to join. Participants must be able to understand the study and follow the instructions and appointments. Those who have had certain penile surgeries, previous implants, infections, or other specific health treatments are not eligible. If accepted, participants will use the RestoreX device before their planned implant surgery and attend follow-up visits as part of the study. Importantly, the device has not been shown to cause any harm to sexual health or overall well-being. This study is currently not yet recruiting participants.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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