A phase II single-arm trial was conducted from June 2017 to October 2018 to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for premature ejaculation (PE) treatment. Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome. TPTNS consisted of 30-min sessions of the application of 20 Hz with a pulse amplitude of 200 µsec. The intensity was adjusted based on individual sensibility. The participants received 3 weekly sessions for 12 consecutive weeks. Follow-up continued for 9 months after therapy completion. The main outcome was a threefold increase in the intravaginal ejaculation latency time (IELT) at week 12. Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12. The IELT increased 4.8-fold, 6.8-fold, and 5.4-fold at weeks 12, 24, and 48, respectively. One episode of constipation was reported, and one patient reported a sensation of heat in the leg during one therapy session. The findings suggest that TPTNS therapy delays ejaculation in patients with lifelong premature ejaculation, with no serious secondary effects. Controlled trials with larger sample sizes are needed to verify these results.

2017年6月至2018年10月进行了II期单臂试验，以评估经皮胫后神经刺激（TPTNS）用于早泄（PE）治疗的疗效和安全性。招募了12名PE且未接受过既往治疗的男性，其中1名退出了研究，11名受试者提供了主要结局的数据。TPTNS包括20 Hz施加30分钟，脉冲幅度为200 µsec的部分。强度根据个人敏感性进行调整。参与者连续12周接受了3次每周会议。治疗结束后继续随访9个月。主要结果是在第12周时阴道内射精潜伏时间（IELT）增加了三倍。完成治疗的11例患者中，有54.5％（p = 0.037）显示在第12周时的IELT基线三倍。在第12、24和48周时，IELT分别增加了4.8倍，6.8倍和5.4倍。据报道，有一次便秘发作，一名患者在一个疗程中报告了腿部发热。研究结果表明，TPNTS疗法可延缓终生早泄患者的射精，没有严重的继发影响。需要通过更大样本量的对照试验来验证这些结果。