{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T00:19:49Z","timestamp":1788826789454,"version":"build-2803163510"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2023,1,11]],"date-time":"2023-01-11T00:00:00Z","timestamp":1673395200000},"content-version":"vor","delay-in-days":782,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T00:00:00Z","timestamp":1605830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,10,10]],"date-time":"2020-10-10T00:00:00Z","timestamp":1602288000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"PathRight Medical"},{"DOI":"10.13039\/100000871","name":"Mayo Clinic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000871","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000871","name":"Mayo Clinic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000871","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jsm.jsexmed.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie\u2019s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3\u00a0months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>The primary outcomes are safety, penile length, penile curvature, Peyronie\u2019s Disease Questionnaire, International Index of Erectile Function, and satisfaction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>6-month (n\u00a0=\u00a064) and 9-month (n\u00a0=\u00a063) outcomes were reported, with a mean duration of PTT use of 31.1\u00a0minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7\u20132.0\u00a0cm) and curvature improvements (18\u201320%). PTT-to-PTT men also achieved additional length (0.6\u20130.8\u00a0cm) without further curvature improvements. An as-treated analysis of PTT use \u226515\u00a0minute\/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18\u201321% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie\u2019s Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6\u00a0months experienced length gains (mean 2.0\u20132.2\u00a0cm), and 61% had curve improvements (16.8\u201321.4\u00b0 [32.8\u201335.8%]). RestoreX was preferred 3\u20134:1 over all other PD treatments, and 100% preferred it over other PTT devices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Implications<\/jats:title>\n                    <jats:p>Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Strengths &amp; Limitations<\/jats:title>\n                    <jats:p>Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (&amp;gt;3\u20139 hours) treatment arm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1016\/j.jsxm.2020.10.003","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T10:10:17Z","timestamp":1605867017000},"page":"2462-2471","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":29,"title":["Outcomes of RestoreX Penile Traction Therapy in Men with Peyronie\u2019s Disease: Results from Open Label and Follow-Up Phases"],"prefix":"10.1093","volume":"17","author":[{"given":"Jason","family":"Joseph","sequence":"first","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Ziegelmann","sequence":"additional","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manaf","family":"Alom","sequence":"additional","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Savage","sequence":"additional","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"},{"name":"Male Fertility and Peyronie\u2019s Clinic , Orem, UT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias S.","family":"K\u00f6hler","sequence":"additional","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Landon","family":"Trost","sequence":"additional","affiliation":[{"name":"Mayo Clinic , , MN , USA"},{"name":"Rochester , , MN , USA"},{"name":"Male Fertility and Peyronie\u2019s Clinic , Orem, UT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,11,20]]},"reference":[{"key":"2023011111071261700_bib1","first-page":"1468","article-title":"Penile traction therapy for treatment of Peyronie\u2019s disease: a single-center pilot study","volume":"5","author":"Levine","year":"2008","journal-title":"J\u00a0Sex Med"},{"key":"2023011111071261700_bib2","first-page":"558","article-title":"Use of penile extender device in the treatment of penile curvature as a result of Peyronie\u2019s disease. 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