No. 2a | Randomized study on the results of a new penile traction device in men with Peyronie's disease - AUA - The Journal of Urology - September 2019"

Study: No. 2 a Author(s):  MJ Ziegelmann et al . Title :   Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial Release :  AUA - The Journal of Urology – September 2019, Volume 202, Page: 599-610

Results of a study on a new penile traction device to treat Peyronie's disease

By Matthew Ziegelmann, Josh Savage, Amir Toussi, Manaf Alom, David Yang, Tobias Kohler and Landon Trost

Summary of the study:

Objective :
Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. To address these issues, the new RestoreX penile traction therapy device was developed in collaboration with the Mayo Clinic.

Materials and methods:
We performed a randomized, controlled, single-blind, intention-to-treat study (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to use the penile traction therapy device for 30 to 90 minutes per day, or no therapy for 3 months. Study inclusion criteria were a curvature of 30 degrees or greater, with no study exclusions due to complex curvatures, hourglass deformity, previous treatments or surgeries for Peyronie's disease, or calcifications. The primary endpoint was safety, and secondary endpoints were penile length and curvature, as well as responses to questionnaires.

Results :
A total of 110 men were randomly assigned in a ratio of 3 to the penile traction therapy group or the control group. The cohorts were well matched, with a mean age of 58.4 years, a history of Peyronie's disease of 49.7 months, and a mean curvature of 59.3 degrees. Overall, penile traction therapy was well tolerated, with only transient and mild adverse events reported. At 3 months, men subjected to penile traction therapy showed significant improvements compared to the control group in penile length (1.5 vs. 0 cm, p < 0.001), curvature (11.7 versus 1.3 degrees, p < 0.01) and erectile function (4.3 versus - 0.7, p < 0.01) according to the International Index of Erectile Function among men with erectile dysfunction. Overall, 77% of men receiving penile traction therapy saw an improvement in curvature (average of -17.2 degrees in 28.2% of respondents), while 94% saw a gain in length (1 .6 cm in 10.9%). Reverse flexion and the white line indicator improved efficiency, validating the main innovations of the device. Among men who had previously used other penile traction therapy devices, 100% preferred the RestoreX device.

Conclusion :
Penile traction therapy with the RestoreX device for 30 to 90 minutes daily was shown to be safe and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, as well as than erectile function in men with erectile dysfunction and Peyronie's disease, without any significant adverse events. To our knowledge, these data represent the only improvements reported for a device used less than 3 to 8 hours per day.