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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial sites expanded: 1 → 4 locationsv5
  2. Notable Primary completion date: Sep 14, 2024 to Sep 14, 2028
    • Study completion date: Sep 14, 2025 to Sep 14, 2030
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Start date changed from estimate of Feb 10, 2022 to Mar 12, 2022
    • Secondary endpoints revised (8)
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05244486
Lead Sponsor Charitable Union for the Research and Education of Peyronie's Disease
Conditions
(from sponsor)
Erectile Dysfunction Following Radical Prostatectomy
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov