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Penile Lengthening Pre-Penile Prosthesis Implantation
Sponsor: University of Pittsburgh
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.
Official title: Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-08-26
Completion Date
2027-02
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Interventions
Penile Traction Device
Patients will be randomized into one of two groups: penile traction therapy 30 min 3x/day x 3 months, or control (no treatment). Preoperative erectile function surveys will be recorded in the EMR per standard of care. Following randomization, patients allocated to the treatment arm will be instructed how to use the device properly. Patients in the treatment arm will record a daily journal of use of the device (Appendix 1). After a minimum of 3 months, patients in the treatment arm will return for their scheduled procedure. Control arm patients will be scheduled directly for an OR date.
Inflatable Penile Prosthesis Implantation
Implantation of a three-component inflatable penile prosthesis.
Locations (1)
UPMC Mercy Hospital, Urology
Pittsburgh, Pennsylvania, United States