Mayo Clinic, Rochester, MN, USA.
Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, USA.
J Sex Med. 2020 Dec;17(12):2462-2471. doi: 10.1016/j.jsxm.2020.10.003. Epub 2020 Nov 20.
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.
To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854).
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 open-label 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.
The primary outcomes are safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction.
6-month (n = 64) and 9-month (n = 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 (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 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 18-21% 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 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices.
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 (>3-9 hours) treatment arm.
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, low-cost option for managing men with PD. Joseph J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med 2020;17:2462-2471.
一项评估 RestoreX 牵引疗法治疗勃起功能障碍（PD）男性疗效的随机对照临床试验已经完成，之前已经报道了 3 个月的结果。本研究报告了原始试验的开放标签和随访阶段的结果。
报告一项随机对照试验（NCT03389854）的 6 个月（开放标签阶段）和 9 个月（随访阶段）结果。
2017 年至 2019 年，在 110 名所有男性勃起功能障碍患者中进行了一项随机对照试验。男性被随机分为 3:1 组接受 RestoreX（PTT）或无治疗（对照组）3 个月，然后进入 3 个月的开放标签和随访阶段。主要结果包括不良事件（AE）、阴茎弯曲和长度变化、勃起功能以及 PD 的标准化和非标准化评估。
报告了 6 个月（n=64）和 9 个月（n=63）的结果，平均 PTT 使用时间为 31.1 分钟。没有报告显著的 AE，最常见的是暂时性红斑和不适，几分钟内即可缓解。在意向治疗分析中，对照组到 PTT 组的男性经历了显著的长度（1.7-2.0cm）和曲率改善（18-20%）。PTT 到 PTT 组的男性也实现了额外的长度（0.6-0.8cm），而没有进一步的曲率改善。对 PTT 使用时间≥15 分钟/天的治疗分析显示，长度增加了 2.0-2.3cm（迄今为止最大的 PTT 组），曲率改善了 18-21%。国际勃起功能指数和勃起功能障碍问卷的所有性功能领域都有显著改善（除了性高潮领域）。95%接受 6 个月治疗的男性获得了长度增加（平均 2.0-2.2cm），61%的男性获得了曲率改善（16.8-21.4°[32.8-35.8%]）。RestoreX 在所有其他勃起功能障碍治疗方法中被 3-4:1 优先选择，100%的人更喜欢它而不是其他 PTT 设备。
每天使用 RestoreX 30 分钟可显著改善勃起功能障碍男性的长度和曲率，且无显著 AE。
优势包括最大的 PTT 随机研究、盲法评估以及包括了几乎没有限制的所有勃起功能障碍男性；局限性包括样本量不足以比较治疗组之间的差异，以及缺乏长时间（>3-9 小时）治疗组。
RestoreX 阴茎牵引疗法可显著改善长度、曲率以及主观和客观的性功能指标，且无显著 AE。RestoreX PTT 是一种安全、保守、低成本的治疗勃起功能障碍的选择。
