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

Study : No. 1 a 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 Release : The Journal of Sexuality Medicine – 2020; 17:2462-2471

Clinical Evaluation of Penile Traction Therapy With RestoreX to Treat Peyronie's Disease: Results of the Open Phase and Follow-up Phase

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

Summary of the study

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

Method :

A randomized, controlled clinical study was conducted from 2017 to 2019 on 110 men suffering from 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 3-month follow-up. Endpoints included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and non-standardized assessments of Peyronie's disease.

Results :

Endpoints included safety, penile length, penile curvature, Peyronie'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 in the PTT group also gained additional length (0.6-0.8 cm) with no further improvement in curvature. An analysis based on PTT use for ≥15 minutes per day showed length gains of 2.0 to 2.3 cm (the largest to date) and curvature improvement of 18 to 21% . All sexual function domains of the International Index of Erectile Function and the Peyronie's Disease Questionnaire were significantly improved (except the orgasmic domain). 95% of men treated for 6 months saw gains in length (average 2.0 to 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 Peyronie's disease treatments, and 100% of men preferred it over 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.

Documents: Click here for the summary in French Click here for the complete study in English