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RECRUITING Not applicable ClinicalTrials.gov

Penile Lengthening Pre-Penile Prosthesis Implantation

Sponsor: J. Peter Rubin, MD • ClinicalTrials.gov ID: NCT07053826

Registry updated: 2026-09-03
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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.

Interventions

  • Penile Traction Device (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 (Procedure)
    Implantation of a three-component inflatable penile prosthesis.

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

Conditions

Erectile Dysfunction

Locations

  • UPMC Mercy Hospital, Urology — Pittsburgh, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record