Abstract
A randomized, controlled trial is ongoing to evaluate the efficacy of a novel penile traction therapy (PTT) device, RestoreX, on outcomes of men with PD. Prior PTT devices have demonstrated notable shortcomings, including a need for 5 hours or more daily to achieve outcomes. Additionally, this study represents the first randomized, controlled trial evaluating the efficacy of PTT in men with PD. To report preliminary 6-month outcomes of PTT with RestoreX in men with PD. A randomized, controlled trial (NCT03389854) is being conducted to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and ≥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy.
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