Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
UPMC Mercy Hospital, Urology
RECRUITING
Pittsburgh
Contact Information
Primary
Roger D Klein, MD, PhD
urologyresearch@upmc.edu
800-533-8762
Backup
Michelle Lucas, MS
mcmeansmm2@upmc.edu
412-624-4708
Time Frame
Start Date:2025-08-26
Estimated Completion Date:2027-02
Participants
Target number of participants:48
Treatments
Active_comparator: Penile Prosthesis Implantation
Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the no intervention arm will proceed directly to implantation of a standard-of-care inflatable penile prosthesis at the next available surgical appointment. They will not use the RestoreX penile traction device. They will complete standardized assessments of sexual function and satisfaction before and after placement.
Experimental: RestoreX and Penile Prosthesis Implantation
Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the intervention arm will be provided with a RestoreX penile traction device, which they will utilize for three months prior to implantation of a standard-of-care inflatable penile prosthesis. They will complete standardized assessments of sexual function and satisfaction before and after placement, as well as a device use diary.