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Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

Who can join

Ages 18 and older · Men

Inclusion Criteria:

* Undergoing bilateral nerve-sparing prostatectomy
* \>18 years old
* Have a regular sexual partner for at least 6 months prior to study enrollment

Exclusion Criteria:

* Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
* Baseline severe erectile dysfunction as measured by the IIEF-EFD
* Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively

About the study

Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.

What is being tested

• RestoreX 1-6 months (randomized phase) (device)
• RestoreX 6-9 months (open label phase) (device)

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease · Participants: 200 · Started: Mar 12, 2022

Contact the study team

• Landon Trost, MD · Phone: 801-655-0015

Official record on ClinicalTrials.gov — NCT05244486

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.