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Penile Lengthening Pre-Penile Prosthesis Implantation
Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
Who can join
Ages 18 and older · Men
Full 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
About the study
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.
What is being tested
- Penile Traction Device (device)
- Inflatable Penile Prosthesis Implantation (procedure)
Sponsor: J. Peter Rubin, MD · Participants: 48 · Started: Aug 26, 2025
Contact the study team
- Roger D Klein, MD, PhD · Phone: 800-533-8762
- Michelle Lucas, MS · Phone: 412-624-4708
Official record on ClinicalTrials.gov — NCT07053826
Locations in the U.S.
| Pennsylvania | UPMC Mercy Hospital, Urology, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.