Penile lengthening with RestoreX before inflatable penile prosthesis surgery
Official title: Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
Run by University of Pittsburgh · NCT07053826 · Data updated 2026-11-12
This test tries whether using the RestoreX penile traction device for several weeks before inflatable penile prosthesis surgery helps men with erectile dysfunction get a longer implant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 48 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | August 26, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07053826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with erectile dysfunction who are scheduled for a standard inflatable penile prosthesis and who meet the trial's eligibility criteria (for example, no prior penile prosthesis or disqualifying penile/pelvic history).
✕Probably not a fit
Men with prior ischemic priapism, prior penile prosthesis, prior use of any penile traction device, prior penile surgeries other than circumcision, prior pelvic radiation, current or prior androgen deprivation therapy, active genital infection, or history of neophallus creation are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men with erectile dysfunction who are scheduled for standard inflatable penile prosthesis implantation will use a commercially available penile traction device (RestoreX) prior to their planned surgery, followed by the usual implant procedure. The study will compare implant length and patient-reported penile length and satisfaction after surgery to expected outcomes without preoperative traction. Participants must meet inclusion and exclusion criteria such as no prior penile prosthesis, no prior penile surgeries beyond circumcision, and no prior pelvic radiation.
Why it matters
Potential benefit: If successful, this approach could increase the length of the implanted prosthesis and improve patients' perceived penile length and satisfaction after surgery.
How similar studies have gone: Small pilot work using other traction devices (such as Andropenis) showed modest increases in stretched and post‑implant length and RestoreX has been used successfully for lengthening in diabetic and post‑prostate surgery patients, but controlled evidence for pre‑prosthesis use is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UPMC Mercy Hospital, Urology
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: J. Peter Rubin, MD — University of Pittsburgh
- Study coordinator: Roger D Klein, MD, PhD
- Email: urologyresearch@upmc.edu
- Phone: 800-533-8762
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.