This study aimed to appraise the effectiveness and tolerability of lidocaine 5% spray in the treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n = 75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n = 75); was given placebo in the form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10–20 min, and then cleaned before planned sexual intercourse. Patients were evaluated with the Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments. The mean values of the AIPE scores, IELTs, and sexual intercourse frequency in the lidocaine 5% spray group were statistically significant increased than the group of placebo after treatment (P value 0.0001). The present study deduced that local use of lidocaine 5% spray on glans penis 10–20 min prior to sexual intercourse could significantly improve PE patients, with tolerated local adverse effects.

本研究旨在评估 5% 利多卡因喷雾剂治疗早泄 (PE) 患者的有效性和耐受性。目前的研究被设计为一项随机单盲安慰剂对照临床试验。对 150 名正常勃起的终生 PE 患者进行了这项研究。他们被随机平均分为两个治疗组。第 1 组（n  = 75）；按需给予利多卡因 5% 喷雾剂 8 周。第 2 组 ( n = 75); 以按需酒精喷雾的形式给予安慰剂 8 周。所有药物都涂在龟头上 10-20 分钟，然后在计划性交前清洁。用阿拉伯早泄指数 (AIPE) 评分、阴道内射精潜伏期 (IELT) 和治疗前后的性交频率对患者进行评估。5%利多卡因喷雾组的AIPE评分、IELTs和性交频率的平均值在治疗后较安慰剂组有统计学意义（P值0.0001）。本研究推断，性交前 10-20 分钟在龟头上局部使用 5% 利多卡因喷雾可显着改善 PE 患者，且可耐受局部不良反应。