Outcomes of a Novel Penile Traction Device in Men with Peyronie’s Disease: A Randomized, Single-Blind, Controlled Trial

No AccessJournal of UrologyAdult Urology1 Sep 2019Outcomes of a Novel Penile Traction Device in Men with Peyronie’s Disease: A Randomized, Single-Blind, Controlled TrialThis article is commented on by the following:Editorial CommentEditorial Comment Matthew Ziegelmann, Josh Savage, Amir Toussi, Manaf Alom, David Yang, Tobias Kohler, and Landon Trost Matthew ZiegelmannMatthew Ziegelmann Mayo Clinic, Rochester, Minnesota More articles by this author , Josh SavageJosh Savage Mayo Clinic, Rochester, Minnesota More articles by this author , Amir ToussiAmir Toussi Mayo Clinic, Rochester, Minnesota More articles by this author , Manaf AlomManaf Alom Mayo Clinic, Rochester, Minnesota More articles by this author , David YangDavid Yang Mayo Clinic, Rochester, Minnesota More articles by this author , Tobias KohlerTobias Kohler Mayo Clinic, Rochester, Minnesota More articles by this author , and Landon TrostLandon Trost *Correspondence: Landon Trost, 200 First St. Southwest, Rochester, Minnesota 55905 telephone: 507-284-4248; FAX: 507-284-4951; E-mail Address: [email protected] Mayo Clinic, Rochester, Minnesota Financial interest and/or other relationship with PathRight Medical. More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000245AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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. References 1. : Peyronie's disease: AUA guideline. J Urol 2015; 194: 745. Link, Google Scholar 2. : External mechanical devices and vascular surgery for erectile dysfunction. J Sex Med 2016; 13: 1579. Google Scholar 3. : Mechanotransduction: all signals point to cytoskeleton, matrix, and integrins. Sci STKE 2002; 2002: pe6. 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Urology 2017; 104: 102. Google Scholar The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. Supported by internal Mayo Clinic funds and an anonymous patient gift to facilitate Peyronie's disease research. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor's Note: This article is the fifth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 623 and 624. © 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byToussi A, Ziegelmann M, Yang D, Manka M, Frank I, Boorjian S, Tollefson M, Köhler T and Trost L (2021) Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled TrialJournal of Urology, VOL. 206, NO. 2, (416-426), Online publication date: 1-Aug-2021.Seftel A (2019) Re: Plication Techniques in Peyronie’s Disease: New DevelopmentsJournal of Urology, VOL. 203, NO. 3, (448-448), Online publication date: 1-Mar-2020.Seftel A (2019) Re: Increased Risk of Cancer in Men with Peyronie’s Disease: A Cohort Study Using a Large United States Insurance Claims DatabaseJournal of Urology, VOL. 203, NO. 2, (236-236), Online publication date: 1-Feb-2020.Seftel A (2019) Re: Current Strategies in the Management of Peyronie’s Disease (PD)—Results of a Survey of 401 Sexual Medicine Experts across EuropeJournal of Urology, VOL. 202, NO. 6, (1080-1081), Online publication date: 1-Dec-2019.Smith J (2019) This Month in Adult UrologyJournal of Urology, VOL. 202, NO. 3, (431-432), Online publication date: 1-Sep-2019.Related articlesJournal of Urology8 Aug 2019Editorial CommentJournal of Urology8 Aug 2019Editorial Comment Volume 202Issue 3September 2019Page: 599-610Supplementary Materials Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.Keywordstractionpatient reported outcome measureserectile dysfunctionequipment and suppliespenile indurationAcknowledgments Leanne Sandieson and Brett Milazzo coordinated the study. Leah Verderame, Elyse Mueller and Kelly Bandilli contributed to the study. PathRight Medical donated the devices.MetricsAuthor Information Matthew Ziegelmann Mayo Clinic, Rochester, Minnesota More articles by this author Josh Savage Mayo Clinic, Rochester, Minnesota More articles by this author Amir Toussi Mayo Clinic, Rochester, Minnesota More articles by this author Manaf Alom Mayo Clinic, Rochester, Minnesota More articles by this author David Yang Mayo Clinic, Rochester, Minnesota More articles by this author Tobias Kohler Mayo Clinic, Rochester, Minnesota More articles by this author Landon Trost Mayo Clinic, Rochester, Minnesota *Correspondence: Landon Trost, 200 First St. Southwest, Rochester, Minnesota 55905 telephone: 507-284-4248; FAX: 507-284-4951; E-mail Address: [email protected] Financial interest and/or other relationship with PathRight Medical. More articles by this author Expand All The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. Supported by internal Mayo Clinic funds and an anonymous patient gift to facilitate Peyronie's disease research. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor's Note: This article is the fifth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 623 and 624. Advertisement PDF downloadLoading ...