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QuoteOutcomes Of A Novel Penile Traction Device (Restorex) In Men With Peyronie's Disease: A Randomized, Single-Blinded, Controlled Trial.Ziegelmann M1, Savage J1, Toussi A1, Alom M1, Yang D1, Kohler T1, Trost L1.Author informationAbstractPURPOSE:Current penile traction therapy (PTT) devices have significant limitations, including a need to utilize 3-8 hours/day. Given these issues, a novel PTT device (RestoreX) was developed in cooperation with Mayo Clinic.MATERIALS AND METHODS:A randomized, controlled, single-blinded, intent-to-treat trial (NCT03389854) was conducted with Peyronie's Disease (Peyronies Disease) men assigned to RestoreX 30-90 min/day or no therapy for 3 months. Inclusion criteria was ≥30° curvature, with no exclusions for complex curvatures, hourglass, prior Peyronies Disease therapy/surgery, or calcification. The primary outcome was safety, and secondary outcomes were penile length, curvature, and questionnaire responses.RESULTS:110 men were randomized 3:1 to PTT or control. Cohorts were well-matched: mean age 58.4 years, Peyronies Disease duration 49.7 months, and curvature 59.3°. Overall, PTT was well tolerated, with only transient and mild adverse events reported. At 3-months, PTT men demonstrated significant improvements over controls in length (1.5 vs 0 cm, p<0.001), curve (-11.7° vs +1.3°, p<0.01), and erectile function (IIEF-EFD +4.3 vs -0.7 among men with erectile dysfunction [Erectile Dysfunction], p=0.01). Overall, 77% of PTT men experienced improved curvature (responders: mean -17.2°, 28.2%), while 94% achieved increased length (+1.6 cm, 10.9%). Counter-bending and the white-line indicator improved efficacy, validating key device innovations. Of those previously using other PTT devices, 100% preferred RestoreX.CONCLUSIONS:PTT with RestoreX 30-90 min/day is safe and results in significant and clinically-meaningful improvements in penile curvature and length in Peyronies Disease men and erectile function in Erectile Dysfunction/Peyronies Disease men, with no significant adverse events. These data represent the only to report improvements with any device <3-8 hours/day.
Quote Counter-bending and the white-line indicator improved efficacy