Recruiting

RestoreX

Sponsor:

J. Peter Rubin, MD

Code:

NCT07053826

Conditions

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Penile Traction Device

Inflatable Penile Prosthesis Implantation

Study Details

Brief 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.

Conditions

Erectile Dysfunction

Study ID

NCT07053826

Start date

Aug 26, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Penile Length [ Time Frame: At screening to approximately three months after enrollment at the time of penile prosthesis implantation ]
  • Prosthesis size [ Time Frame: 0-4 months after enrollment at the time of penile prosthesis implantation ]
  • Sexual Satisfaction [ Time Frame: At enrollment and at three-month postoperative follow up. ]
  • Incidence of Satisfaction with Penile Length [ Time Frame: 3-8 months postoperatively ]

Central Contacts and Locations

Central contacts

Roger D Klein, MD, PhD

800-533-8762urologyresearch@upmc.edu

Michelle Lucas, MS

412-624-4708mcmeansmm2@upmc.edu

Locations

UPMC Mercy Hospital, Urology

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Michelle Lucas, MS

412-624-4708mcmeansmm2@upmc.edu

Eleanor Shirley, MA, CCRC

shirleye@upmc.edu

More Information

Sponsor

J. Peter Rubin, MD

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Erectile Dysfunction
  • Inflatable Penile Prosthesis
  • Penile Traction Therapy
  • RestoreX
  • Penile Enlargement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by J. Peter Rubin, MD on 2026-09-03.