Tags

Type your tag names separated by a space and hit enter

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.
J Urol. 2019 09; 202(3):599-610.JU

Abstract

PURPOSE

Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic.

MATERIALS AND METHODS

We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses.

RESULTS

A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls 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-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device.

CONCLUSIONS

Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.

Authors+Show Affiliations

Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.Mayo Clinic, Rochester, Minnesota.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30916626

Citation

Ziegelmann, Matthew, et al. "Outcomes of a Novel Penile Traction Device in Men With Peyronie's Disease: a Randomized, Single-Blind, Controlled Trial." The Journal of Urology, vol. 202, no. 3, 2019, pp. 599-610.
Ziegelmann M, Savage J, Toussi A, et al. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019;202(3):599-610.
Ziegelmann, M., Savage, J., Toussi, A., Alom, M., Yang, D., Kohler, T., & Trost, L. (2019). Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. The Journal of Urology, 202(3), 599-610. https://doi.org/10.1097/JU.0000000000000245
Ziegelmann M, et al. Outcomes of a Novel Penile Traction Device in Men With Peyronie's Disease: a Randomized, Single-Blind, Controlled Trial. J Urol. 2019;202(3):599-610. PubMed PMID: 30916626.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. AU - Ziegelmann,Matthew, AU - Savage,Josh, AU - Toussi,Amir, AU - Alom,Manaf, AU - Yang,David, AU - Kohler,Tobias, AU - Trost,Landon, Y1 - 2019/08/08/ PY - 2019/3/28/pubmed PY - 2019/8/28/medline PY - 2019/3/28/entrez KW - equipment and supplies KW - erectile dysfunction KW - patient reported outcome measures KW - penile induration KW - traction SP - 599 EP - 610 JF - The Journal of urology JO - J Urol VL - 202 IS - 3 N2 - PURPOSE: Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. MATERIALS AND METHODS: We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. RESULTS: A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls 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-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. CONCLUSIONS: Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day. SN - 1527-3792 UR - https://wwww.unboundmedicine.com/medline/citation/30916626/Outcomes_of_a_Novel_Penile_Traction_Device_in_Men_with_Peyronie's_Disease:_A_Randomized_Single_Blind_Controlled_Trial_ DB - PRIME DP - Unbound Medicine ER -