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

Study : No. 2has Author(s): M.J. Ziegelmann & al. Title : Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial Publication: 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

Study summary:

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 conducted 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 daily, or to receive no therapy for 3 months. Inclusion criteria were a curvature of 30 degrees or greater, with no exclusions due to complex curvatures, hourglass deformity, prior 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 questionnaire responses.

Results :
A total of 110 men were randomly assigned in a ratio of 3 to either the penile traction therapy group or the control group. The cohorts were well matched, with a mean age of 58.4 years, a mean 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 undergoing penile traction therapy showed significant improvements in penis length compared to the control group (1.5 vs. 0 cm, p < 0.05). < 0.001), the curvature (11.7 versus 1.3 degrees, p < 0.01) and erectile function (4.3 vs -0.7, p < 0.01) according to the International Erectile Function Index among men with erectile dysfunction. Overall, 77% of men using penile traction therapy experienced an improvement in curvature (average of -17.2 degrees in 28.2% of respondents), while 94% observed a length increase (1.6 cm in 10.9%). Reverse flexion and the white line indicator improved effectiveness, validating the device's key innovations. 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 has been shown to be safe and to result in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, as well as improvements in erectile function in men with both 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 for less than 3 to 8 hours per day.