Using RestoreX device to help maintain erectile function after prostate surgery
Official title: Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Run by Charitable Union for the Research and Education of Peyronie's Disease · NCT05244486 · Data updated 2026-11-12
This study is testing whether the RestoreX device can help men keep their erectile function after prostate surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Charitable Union for the Research and Education of Peyronie's Disease Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Status | Recruiting |
| Started | March 12, 2022 |
| Main results expected | September 14, 2028 |
| Study ends | September 14, 2030 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT05244486 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men over 18 years old undergoing bilateral nerve-sparing prostatectomy with preserved baseline erectile function.
✕Probably not a fit
Patients with severe erectile dysfunction at baseline or those requiring additional treatments like radiation therapy post-surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the RestoreX penile traction device in preserving erectile function in men who are undergoing robotic-assisted prostatectomy with bilateral nerve preservation. Participants will be men with moderate erectile dysfunction or better, and the primary outcome will be measured through changes in the IIEF-EFD scores at 6 months. Secondary outcomes will include various questionnaire results at 3, 6, and 9 months to assess overall sexual function and satisfaction.
Why it matters
Potential benefit: If successful, this approach could significantly improve erectile function preservation in men post-prostatectomy.
How similar studies have gone: Previous studies have shown promising results with similar penile traction therapy approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Mayo Clinic Arizona
Phoenix, Arizona, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
University Hospital
Newark, New Jersey, United States Recruiting -
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States Recruiting
Study contacts
- Study coordinator: Landon Trost, MD
- Email: landontrost@gmail.com
- Phone: 801-655-0015
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Platelet-Rich Plasma for Erectile Dysfunction After Prostate Surgery
This trial tests whether injecting a patient’s own platelet-rich plasma can improve erectile function in men who have persistent ED more than a year after nerve-sparing radical prostatectomy.
-
Tractography-Guided Nerve-Sparing in Prostate Cancer
A nerve-sparing approach during prostate cancer surgery uses 3D nerve maps created from diffusion tensor imaging to guide the surgeon and see if preservation of nerves improves function.
-
Impact of an accessory pudendal artery on erection recovery after nerve-sparing prostate surgery
This study checks if preserving an extra artery (the accessory pudendal artery) during robotic prostate removal helps men regain erections after nerve-sparing surgery.
-
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Prostate Surgery
This trial tests a virtual, self-directed program before and after robot-assisted prostate surgery to help men regain erectile function and urinary continence.
-
Mobile perioperative education with video pelvic floor training after radical prostatectomy
This test checks whether a smartphone app that provides perioperative education, reminders, and video-guided pelvic floor exercises helps men undergoing radical prostatectomy have less urinary leakage and better erectile function.
-
New nerve surgery to help men regain erections after prostate cancer surgery
This study will try a new nerve graft surgery using the ilioinguinal nerve to help men who lost erections after prostate removal regain erectile function within a year.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.