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Penile Lengthening Before Penile Prosthesis Implantation

This study is looking at whether using a device called RestoreX before getting an inflatable penile prosthesis (IPP) can help increase penile length. Men with erectile dysfunction (ED) who are already scheduled for an IPP implantation can join. Half of the participants will use the RestoreX device for 30 minutes, three times a day, for three months, while the other half will not use the device. Researchers will measure penile length and the size of the prosthesis used during surgery, and also assess sexual satisfaction to see if the RestoreX device makes a difference. The study aims to enroll 48 participants, but its current recruitment status is unclear.

Study design
This is an interventional study that plans to enroll 48 men. Participants will be randomly assigned to either use a penile traction device or receive no treatment before surgery.
What's involved
You would either use a penile traction device for 30 minutes, three times a day, for three months, or be in a control group with no treatment. You will have measurements taken at screening, at the time of surgery (0-4 months after enrollment), and three months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for three months after their penile prosthesis implantation surgery.

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NCT07053826

Penile Lengthening Pre-Penile Prosthesis Implantation

Recruiting
NAAges 18+InterventionalTreatment
University of Pittsburgh
~48 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:Penile Traction DeviceInflatable Penile Prosthesis Implantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Penile Length
Measured over At screening to approximately three months after enrollment at the time of penile prosthesis implantation
+3 more outcomes measured

Conditions

Erectile Dysfunction

Explore related trials

Erectile Dysfunction

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

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

Who to contact

Roger D Klein, MD, PhD
[email protected]
800-533-8762
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Penile LengthAt 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 size0-4 months after enrollment at the time of penile prosthesis implantation

    Size of inflatable penile prosthesis cylinders placed

  • Sexual SatisfactionAt 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 Length3-8 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.