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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease • ClinicalTrials.gov ID: NCT05244486

Registry updated: 2026-08-26
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Description

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.

Interventions

  • RestoreX 1-6 months (randomized phase) (Device)
    Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months.
  • RestoreX 6-9 months (open label phase) (Device)
    Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending).

Eligibility 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

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Locations

  • Mayo Clinic Arizona — Phoenix, Arizona, United States
  • Northwestern University — Chicago, Illinois, United States
  • University Hospital — Newark, New Jersey, United States
  • The Male Fertility and Peyronie's Clinic — Orem, Utah, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record