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RestoreX for Erectile Dysfunction After Prostatectomy

This study is looking at how well the RestoreX penile traction device works to help men keep their erectile function after having a robotic-assisted prostatectomy (surgery to remove the prostate). Researchers want to see if using the RestoreX device can help improve erectile function. You might be able to join if you are over 18, having a bilateral nerve-sparing prostatectomy, and have a regular sexual partner. The main goal is to see how erectile function changes at 6 months after surgery. The study is currently unclear on its status and plans to enroll 200 participants.

Study design
This is an interventional study with a randomized phase for the first 1-6 months, followed by an open-label phase for all participants from 6-9 months. It plans to enroll 200 male participants.
What's involved
Participants in the RestoreX group will use the device for 30-60 minutes, 5-7 days a week, starting 1 month after surgery and continuing until 6 months. All participants will be allowed to use the therapy from 6-9 months.
Compensation
Not stated in the trial record.
Follow-up
Erectile function will be measured at 6 months, and questionnaire outcomes will be assessed at 3, 6, and 9 months.

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NCT05244486

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

Recruiting
NAAges 18+InterventionalPrevention
Charitable Union for the Research and Education of Peyronie's Disease
~200 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:RestoreX 1-6 months (randomized phase)RestoreX 6-9 months (open label phase)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Erectile Function Post-Prostatectomy
Measured over 6 months

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Explore related trials

Erectile Dysfunction

Where it's being run

4 sites across 4 states
Arizona1
Illinois1
New Jersey1
Utah1

Who to contact

Landon Trost, MD
[email protected]
801-655-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Erectile Function Post-Prostatectomy6 months

    Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function.