madman
Super Moderator
Outcomes Of A Novel Penile Traction Device (Restorex) In Men With Peyronie's Disease: A Randomized, Single-Blinded, Controlled Trial.
Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L
Outcomes Of A Novel Penile Traction Device (Restorex) In Men With Peyronie's Disease: A Randomized, Single-Blinded, Controlled Trial. - PubMed - NCBI
Abstract
PURPOSE:
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 (PD) 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 PD 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, PD 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 [ED], 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 PD men and erectile function in ED/PD men, with no significant adverse events. These data represent the only to report improvements with any device <3-8 hours/day.
Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L
Outcomes Of A Novel Penile Traction Device (Restorex) In Men With Peyronie's Disease: A Randomized, Single-Blinded, Controlled Trial. - PubMed - NCBI
Abstract
PURPOSE:
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 (PD) 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 PD 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, PD 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 [ED], 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 PD men and erectile function in ED/PD men, with no significant adverse events. These data represent the only to report improvements with any device <3-8 hours/day.
