NCT07053826 Penile Lengthening Pre-Penile Prosthesis Implantation
| NCT ID | NCT07053826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-08-26 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
J. Peter Rubin, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07053826 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07053826 currently recruiting?
Yes, NCT07053826 is actively recruiting participants. Contact the research team at urologyresearch@upmc.edu for enrollment information.
Where is the NCT07053826 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07053826 clinical trial?
NCT07053826 is sponsored by University of Pittsburgh. The principal investigator is J. Peter Rubin, MD at University of Pittsburgh. The trial plans to enroll 48 participants.