NCT07053826 · University of Pittsburgh
Penile Lengthening Pre-Penile Prosthesis Implantation
What this study is about
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.
View original scientific 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
DEVICE
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.
PROCEDURE
Inflatable Penile Prosthesis Implantation
Implantation of a three-component inflatable penile prosthesis.
Primary outcome measures
Penile Length
Time frame: At screening to approximately three months after enrollment at the time of penile prosthesis implantation
Change in stretched penile length measured at time of enrollment and intraoperatively at the time of IPP implantation, measured in cm.
Prosthesis size
Time frame: 0-4 months after enrollment at the time of penile prosthesis implantation
Size of inflatable penile prosthesis cylinders placed
Sexual Satisfaction
Time frame: At enrollment and at three-month postoperative follow up.
Change in patient-reported satisfaction with their sexual function from enrollment to final postoperative follow up using the validated IIEF-15 (International Index of Erectile function - 15 item) questionnaire, which has a minimum score of 6 and maximum score of 75 with a larger number indicating improved sexual satisfaction. The change seen in participants assigned to the RestoreX device arm will be compared to the change seen in patients assigned to the control arm.
Incidence of Satisfaction with Penile Length
Time frame: 3-8 months postoperatively
A comparison of the incidence of participants reporting satisfaction with their penile length, expressed as a percentage or all participants within each group, based on participant reporting to an investigator during their surgical follow up.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
Collaborators
Pathright Medical
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations