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Recruiting
NCT07053826
Penile Lengthening Pre-Penile Prosthesis Implantation
Conditions: Erectile Dysfunction
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: J. Peter Rubin, MD
Location: UPMC Mercy Hospital, Urology Pittsburgh Pennsylvania
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
Source: ClinicalTrials.gov (NCT07053826). StuddyBuddy aggregates publicly available trial information.