No. 1a | Results of RestoreX™ penile traction therapy in men with Peyronie's disease: open access and follow-up phases

Study : No. 1has Author(s): J.Joseph & al Title : Outcomes of RestoreX™ Penile Traction Therapy in Men with Peyronie's Disease: Results from Open Label and Follow-up Phases Publication: The Journal of Sexual Medicine – 2020; 17:2462-2471

Clinical evaluation of penile traction therapy with RestoreX for the treatment of Peyronie's disease: Results of the open-label and follow-up phases

By Jason Joseph, Matthew J Ziegelmann, Manaf Alom, Joshua Savage, Tobias S Köhler, Landon Trost

Study summary

Background: A randomized, controlled clinical trial evaluating the efficacy of penile traction therapy with RestoreX for treating Peyronie's disease (PD) was conducted, and the 3-month results were previously reported. This study presents the results of the open-access and follow-up phases of the initial trial.

Method :

A randomized, controlled clinical trial was conducted from 2017 to 2019 involving 110 men with Peyronie's disease. Participants were randomly assigned in a 3:1 ratio to the RestoreX (PTT) group and the no-treatment (control) group for 3 months, followed by open-access phases and a 3-month follow-up. Outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and non-standardized assessments of Peyronie's disease.

Results :

Evaluation criteria included safety, penile length, penile curvature, Peyronie's disease questionnaire, International Index of Erectile Function, and satisfaction. Outcomes were reported at 6 months (n = 64) and 9 months (n = 63), with a mean duration of penile traction therapy (PTT) use of 31.1 minutes. No significant adverse events were reported, with temporary redness and discomfort being the most common symptoms, resolving within minutes. In the intention-to-treat analysis, men from the control group to the PTT group experienced significant improvements in both length (1.7–2.0 cm) and curvature (18–20%). Men from the PTT group to the PTT group also achieved an additional length gain (0.6–0.8 cm) without further improvement in curvature. An analysis based on the use of PTT for ≥15 minutes per day showed length gains of 2.0 to 2.3 cm (the largest to date) and an improvement in curvature of 18 to 21%. All domains of sexual function in the International Index of Erectile Function and the Peyronie's Disease Questionnaire were significantly improved (except for the orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0 to 2.2 cm), and 61% experienced improvements in curvature (16.8–21.4° [32.8–35.8%]).RestoreX was preferred 3-4 times more often than all other treatments for Peyronie's disease, and 100% of men preferred it to other PTT devices.

Clinical implications: Daily use of RestoreX for 30 minutes results in significant improvements in length and curvature in men with Peyronie's disease, without significant adverse events.