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

RecruitingNAAges 18 Years - anyMaleCharitable Union for the Research and Education o…
NCT05244486 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

4 sites
Mayo Clinic Arizona
Phoenix, United States
Northwestern University
Chicago, United States
University Hospital
Newark, United States
The Male Fertility and Peyronie's Clinic
Orem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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