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

Etude : N°2a Auteur(s) : M.J. Ziegelmann & al. Titre : Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial Parution : AUA - The Journal of Urology - September 2019, Volume 202, Page: 599-610

Results of a study of a novel penile traction device to treat Lapeyronie'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 3-8 hours a day. In response to these problems, 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 Lapeyronie's disease who were assigned to use the penile traction therapy device for 30 to 90 minutes a day, or no therapy for 3 months. Study inclusion criteria were a curvature of 30 degrees or more, with no study exclusions due to complex curvatures, hourglass deformity, previous treatment or surgery for Lapeyronie's disease, or calcifications. The primary endpoint was safety, and secondary endpoints were penile length and curvature, and questionnaire responses.

Results:
A total of 110 men were randomized in a ratio of 3 to the penile traction therapy or control group. The cohorts were well matched, with a mean age of 58.4 years, a history of Lapeyronie's disease of 49.7 months and a mean curvature of 59.3 degrees. Overall, penile traction therapy was well tolerated, with only transient, mild adverse events reported. At 3 months, men undergoing penile traction therapy showed significant improvements over the control group in penile length (1.5 vs. 0 cm, p < 0.001), curvature (11.7 vs. 1.3 degrees, p < 0.01) and erectile function (4.3 vs. - 0.7, p < 0.01) according to the International Index of Erectile Function among men with erectile dysfunction. Overall, 77% of men undergoing penile traction therapy saw an improvement in curvature (average of -17.2 degrees in 28.2% of respondents), while 94% observed a gain in length (1.6 cm in 10.9%). Reverse bending and the white line indicator improved efficacy, 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 per day was found to be safe and resulted in significant, clinically meaningful improvements in penile curvature and length in men with Lapeyronie's disease, as well as erectile function in men with erectile dysfunction and Lapeyronie'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 a day.