To report open-label phase data from a recent randomized, controlled trial (RCT). Prior data from the study demonstrated improved penile length and erectile function among post-prostatectomy men treated with Restorex penile traction therapy (RxPTT).
A RCT (NCT05244486) evaluated RxPTT vs no treatment (NoTx) x 5 months, followed by a 3-month open-label phase. Men were stratified based on as-treated data: Gr1=NoTx, Gr2 =NoTx→Tx, Gr3=Tx→NoTx, Gr4=Tx. Assessments included stretched penile length and standardized (International Index of Erectile Function [IIEF]) and non-standardized questionnaires.
82 men were enrolled (mean age 58.6) with 9-month data available in 45. Baseline characteristics were similar between cohorts. Comparing Gr1 and Gr4 (respectively), notable differences included: IIEF Erectile Function Domain (IIEF-EFD -8 vs -0.5, p=0.16), penile length (-0.1 vs +1.7 cm, p<0.01), intracavernosal injection use (86% vs 14%, p<0.01), Sexual Encounter Profile (SEP) 2 (50 vs 100%, p<0.01), SEP 3 (33 vs 100%, p<0.01). Men who crossed over to Tx (Gr2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EFD -6) compared to men treated early (Gr3&4). Those who crossed over to NoTx after initial Tx (Gr3) experienced preserved length (+1.8 cm), and erectile function (IIEF-EFD +0) despite therapy discontinuation.
Use of RxPTT beginning 1-month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy. If confirmed, these results represent the first post-op therapy shown in a RCT to improve erectile function post-prostatectomy. External validation is warranted.

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