RECRUITING

Penile Lengthening Pre-Penile Prosthesis Implantation

Description

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.

Study Overview

Study Details

Study overview

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.

Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction

Penile Lengthening Pre-Penile Prosthesis Implantation

Condition
Erectile Dysfunction
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Mercy Hospital, Urology, Pittsburgh, Pennsylvania, United States, 15219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

J. Peter Rubin, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2027-02