N°1a | Results of RestoreX™ penile traction therapy in men with Lapeyronie's disease: open access and follow-up phases

Etude : N°1a Author(s): J.Joseph & al Titre : 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 Medecine - 2020; 17:2462-2471

Clinical evaluation of penile traction therapy with RestoreX to treat Lapeyronie's disease: results from open 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 to treat Lapeyronie's disease (PD) was conducted and 3-month results were previously reported. This study presents the results of the open access and follow-up phases of the initial trial.

Méthode :

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

Résultats :

Evaluation criteria included safety, penile length, penile curvature, Lapeyronie's disease questionnaire, International Index of Erectile Function and satisfaction. At 6 months (n = 64) and 9 months (n = 63), results were reported, 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 and resolving within minutes. In the intention-to-treat analysis, men from the control group to the PTT group experienced significant improvements in length (1.7-2.0 cm) and curvature (18-20%). Men from the PTT group to the PTT group also achieved additional length (0.6-0.8 cm) with no further improvement in curvature. An analysis based on the use of PTT for ≥15 minutes per day showed length gains of 2.0-2.3 cm (the largest to date) and curvature improvement of 18-21%. All domains of sexual function on the International Index of Erectile Function and the Lapeyronie Disease Questionnaire were significantly improved (with the exception of the orgasmic domain). 95% of men treated for 6 months saw gains in length (mean 2.0-2.2 cm), and 61% saw improvements in curvature (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4 times more often than all other treatments for Lapeyronie'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 Lapeyronie's disease, without significant adverse events.