Penile Lengthening Pre-Penile Prosthesis Implantation

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07053826
Status
Recruiting
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Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Penile Length [ Time Frame: At screening to approximately three months after enrollment at the time of penile prosthesis implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Mercy Hospital, UrologyPittsburghPennsylvania15219
Michelle Lucas, MS
[email protected]
412-624-4708
Eleanor Shirley, MA, CCRC
[email protected]

Find similar trials in Pittsburgh, PA

By research site
UPMC Mercy Hospital, Urology· Pittsburgh, PA

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