Introduction: Penile length loss and erectile dysfunction are common post-prostatectomy (post-RP). Recent results from a randomized, controlled study (RCT) of RestoreX penile traction therapy (RxPTT) demonstrated preserved erectile function and penile length improvements in men post-RP. The current objective is to report outcomes of the open label phase (6-9 month time point).
Methods: A randomized, controlled trial (NCT03500419) has been completed of 82 men. Men were randomized 1-month post-RP to no treatment (NoTx, n=27) or RxPTT (n=55) for 5 months. Participants then entered an open label phase for 3 months. Assessments included stretched penile length (corona), standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. Comparisons of changes from baseline were performed between cohorts using an as-treated analysis.
Results: Of the 82 men enrolled (mean age 58.6), 55 had 6-month, and 42 had 9-month data available to review. Baseline characteristics were similar between cohorts. In the as-treated analysis (NoTx x 8 months n=7, RxPTT x 8 months n=12, respectively), differences were as noted: IIEF-EFD (-8 vs -0.5, p=0.19), IIEF-OFD (-3 vs -2, p=0.86), IIEF-SD (-1 vs 0.5, p=0.09), IIEF-ISD (-3 vs -0.5, p=0.31), IIEF-OSD (-2 vs 0, p=0.29), penile length (-0.1 vs +1.8 cm, p<0.01), PDE5 use (86% vs 75%, p=0.57), intracavernosal injection use (86% vs 17%, p<0.01). Comparisons of men who were NoTx x 8 months (n=7) to those crossing over to RxPTT during the open label phase (n=8) demonstrated: IIEF-EFD (-8 vs -6, p=0.49), IIEF-OFD (-3 vs -1, p=0.90), IIEF-SD (-1 vs 0, p=0.55), IIEF-ISD (-3 vs -1, p=0.45), IIEF-OSD (-2 vs -1, p=0.51), penile length (-0.1 vs +0.69 cm, p=0.39). Men who crossed over from RxPTT to NoTx (n=10) had relatively preserved improvements compared to those who continued with RxPTT during the open label phase (n=12): IIEF-EFD (0 vs -0.5, p=0.95), IIEF-OFD (-3.5 vs -2, p=0.97), IIEF-SD (0 vs 0.5, p=0.18), IIEF-ISD (0 vs -0.5, p=0.87), IIEF-OSD (0 vs 0, p=0.66), penile length (+1.8 vs +1.8, p=0.99).
Conclusions: Although sample size and statistical power are limited, results from the open label phase confirm earlier findings of preserved sexual function and penile length in men treated with RxPTT compared to controls. Men who crossed over from controls to Tx experience benefits, although not as significant as those who were treated beginning at 1 month post-prostatectomy. Men who stopped Tx after 6 months demonstrated stable improvements from baseline, suggesting a preserved effect of RxPTT even after discontinuing use.
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