Presentation Authors: David Yang*, Rochester, MN, Yifan Meng, St. Louis, MO, Joshua Savage, Kevin Wymer, Tobias Kohler, Landon Trost, Rochester, MN
Introduction: Several studies have demonstrated improvements in erectile function (EF) among Peyronie&[prime]s disease (PD) men undergoing penile traction therapy (PTT). However, no randomized controlled trials (RCT) have confirmed this finding or attempted to differentiate the changes in EF from improvements in curvature. Therefore, we sought to identify the impact of PTT on EF in a PD RCT.
Methods: A RCT (NCT03389854) is ongoing to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groups: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and â‰¥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to questionnaires. Assessments are obtained at baseline, 3, and 6 months after starting therapy. To specifically evaluate EF, patients were administered the IIEF Questionnaire and SEP2 and SEP3. To differentiate improvements in EF from changes in PD, patients were asked the non-standardized question, &[Prime]has the treatment you have been taking improved your erectile function?&[Prime]
Results: Three and 6-month data is available on 75 and 36 men, respectively. Mean baseline IIEF-EFD scores was 19.3, with 81% of men able to penetrate (SEP2) and 75% reporting sufficient EF duration to have successful intercourse (SEP3). At 3-months, PTT patients experienced significant improvements on the IIEF-EFD compared to controls (+2.9 vs -0.3, p=0.02), which remained statistically significant once controlling for improvements in curvature and length (p < 0.05). Among those who answered &[Prime]No&[Prime] to SEP3, after 3 months, 50% of men (5/10) in the PTT arm responded &[Prime]Yes&[Prime] compared to 20% (1/5) in the control arm, suggesting improvements in EF, independent of changes in curvature (p=0.58). For the question, &[Prime]has the treatment you have been taking improved your erectile function,&[Prime] 63% (34/54) men in the PTT arms answered, &[Prime]Yes&[Prime] compared to 12% (1/8) in the control group (p=0.02). Among men in the control arm who began PTT at 3 months, IIEF-EFD increased by 1.1 points (n=8, p=0.48), and 43% (3/7) indicated that PTT improved their EF.
Conclusions: PTT with RestoreX results in statistically significant improvements in standardized and non-standardized assessments of EF in PD men, independent of improvements in curvature and length. Although intriguing, these findings suggest a need for further study, particularly given the absence of a viable sham control.