MP45-19 USE OF RESTOREX PENILE TRACTION THERAPY FOR TREATMENT OF PENILE LENGTH LOSS IN DIABETIC MEN

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (MP45)1 Apr 2020MP45-19 USE OF RESTOREX PENILE TRACTION THERAPY FOR TREATMENT OF PENILE LENGTH LOSS IN DIABETIC MEN Madeleine Manka*, Joshua Savage, David Yang, Kevin Wymer, and Trost Landon Madeleine Manka*Madeleine Manka* More articles by this author , Joshua SavageJoshua Savage More articles by this author , David YangDavid Yang More articles by this author , Kevin WymerKevin Wymer More articles by this author , and Trost LandonTrost Landon More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000900.019AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Penile length loss and erectile dysfunction (ED) are common complaints among men with diabetes mellitus (DM), with some data suggesting a mean 1 cm loss. Recently, a randomized controlled trial evaluating the efficacy of a novel penile traction device, RestoreX (PTTRx), demonstrated significant improvements in penile length and erectile function in men with Peyronie’s Disease. Given these findings, we sought to determine the efficacy of RestoreX in improving penile length and erectile function in DM men. METHODS: A randomized, controlled trial (NCT18006696) is ongoing to evaluate the impact of PTT with RestoreX in 100 men with DM. Men are randomized to one of four groupings for 6 months: Group 1 - no therapy (control); Group 2 - Restorex for 30 minutes 2x/day x 3 months, followed by no use x 3 months; Group 3 – Restorex for 30 minutes 2x/day x 3 months, followed by once weekly x 30 minutes x 3 months; Group 4 - Restorex for 30 minutes 2x/day x 6 months. Assessments of stretched penile length, erectile function, and standardized and non-standardized questionnaires are administered at each visit to evaluate sexual function. RESULTS: A total of 88 men (mean age 54.9) have been enrolled to date, with 3-month data available on 56 (control=17, traction=39). Mean duration of DM was 10.7 years (HbA1c 7.1), with men taking a median of 2 medications (33% on insulin). Seventy-four percent of men had ED (median duration 3 years), while 84% reported penile shortening (mean 4.1 cm). Baseline International Index of Erectile Function Erectile Function Domain (IIEF-EFD) scores were 19 (median), and baseline penile length to corona and tip were 13 cm and 16 cm, respectively. Following 3-months of treatment, PTT men demonstrated a 0.9 cm greater improvement in penile length compared to controls (p<0.01), with 79% of PTT men experiencing length gains. Among men with baseline ED, PTT resulted in a 5 point IIEF-EFD improvement vs 0.3 in controls (p<0.05). The Intercourse Satisfaction Domain demonstrated non-statistically significant improvements (+1.75 vs -0.7, p=0.12), while the Overall Satisfaction Domain was significantly improved (+1.8 vs -0.5, p<0.01). There were no significant or long-term adverse events associated with device use. CONCLUSIONS: Based on preliminary data, PTT with RestoreX results in statistically significant objective and subjective improvements in penile length, erectile function, and overall sexual satisfaction in men with DM. RestoreX therefore represents a viable treatment option for this common but difficult to treat problem. Source of Funding: Path Right Medical provided devices to patients free of charge & Internal institutional funding from Mayo Clinic © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e671-e672 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Madeleine Manka* More articles by this author Joshua Savage More articles by this author David Yang More articles by this author Kevin Wymer More articles by this author Trost Landon More articles by this author Expand All Advertisement PDF downloadLoading ...