Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
UPMC Mercy Hospital, Urology
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
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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