Outcomes of RestoreX Penile Traction Therapy in Men with Peyronie’s Disease: Results from Open Label and Follow-Up Phases

Abstract

Background: A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie's disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial. Aim: To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854). Methods: A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month openlabel and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD. Outcomes: The primary outcomes are safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction. Results: 6-month (n ¼ 64) and 9-month (n ¼ 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7e2.0 cm) and curvature improvements (18e20%). PTT-to-PTT men also achieved additional length (0.6e0.8 cm) without further curvature improvements. An as-treated analysis of PTT use !15 minute/day demonstrated 2.0-to 2.3-cm length gains (largest of any PTT to date) and 18e21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0e2.2 cm), and 61% had curve improvements (16.8e21.4 [32.8e35.8%]). RestoreX was preferred 3e4:1 over all other PD treatments, and 100% preferred it over other PTT devices. Clinical Implications: Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs. Strengths & Limitations: Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3e9 hours) treatment arm. Conclusion: PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, lowcost option for managing men with PD.

Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial

“…Improvements in erectile function were also observed in a RCT evaluating the efficacy PTT in men with PD. 12,14 As with the current study, improvements achieved the minimally clinically significant threshold and provide further supporting evidence for an impact of therapy on erectile function. Although the exact mechanism for these improvements is unknown, potential explanations could include tensile-force mediated release of nitric oxide and upregulation of nitric oxide synthase, as demonstrated in animal models and human vascular studies, or diminished fibrosis (ie preserved penile length) leading to lower rates of venous leak.…”

“…Results are consistent with other RestoreX PTT studies which have shown improvements ranging from 1.3–2.3 cm in other cohorts. 12,14,18 This contrasts with the previously cited VED RCT, where no statistically significant increase in length was noted in the VED arm compared to baseline. 10 Interestingly, in the current study, control men were found to have no changes in objective penile length (+0.3 cm) after 6 months, despite 59% reporting subjective losses, consistent with other reports.…”

“…Adverse events were similar to previously published series of PTT and demonstrated mild, transient changes with penile erythema, discomfort and sensory changes in 20.0%, 36.7%, and 10.1% of men, respectively (table 4). 12,14 One patient experienced symptoms >24 hours, with subsequent resolution over the following days, while all others resolved within minutes of discontinuing treatment. One patient in the PTT treatment group reported de novo penile curvature consistent with PD vs none in the control arm (p=0.32).…”

Current trends in non‐surgical management of Peyronie's disease—A narrative review

“…No significant change in the mean curvature was observed in the control group (n = 39). 86 Joseph et al 87 performed a RCT comparing PTT with no intervention (3:1) on 110 patients. The PTT resulted in approximately 18−21% mean curve reduction, significantly improved compared with the control group, and 61% of the patients in the PTT group reported a reduction in penile curvature at 6 months.…”

Efficacy of RestoreX after prostatectomy: open‐label phase of a randomized controlled trial

“…Andropenis [Andromedical, Madrid, Spain], PeniMaster [MSP Concept GmbH & Co. KG, Berlin, Germany], X4 Labs [X4 Labs Canada Inc., Vaudreuil‐dorion, Quebec, Canada], Phallosan Forte [Orbisan Ltd, San Gwann, Malta]), Restorex PTT (RxPTT) introduced several characteristics which allowed greater application of traction forces, including a modified penile clamping mechanism (which displaces force more broadly to the head of the penis), counterbending (not applicable in the current study), stronger mechanical springs, wider displacement base (to better displace the greater forces), and dynamic adjustment of traction during use. Due to these changes, initial clinical trials of RxPTT in men with Peyronie's disease demonstrated consistent improvements in length and curve with 30 min of daily use, compared to variably effective outcomes with 2–9 h of daily use required for first‐generation devices [9–14]. Unexpectedly, the data also demonstrated improvements in erectile function, which was of unclear significance initially.…”