Evaluation of the Efficacy and Safety of On-Demand Tadalafil Alone or Combined With Lidocaine Spray for Treating Patients With Comorbid Erectile Dysfunction and Premature Ejaculation: A Randomized Controlled Trial.
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Abstract
Background: To evaluate the efficacy and safety of on-demand 20 mg tadalafil alone or combined with lidocaine spray for treating patients with comorbid erectile dysfunction (ED) and premature ejaculation (PE).
Methods: This randomized controlled trial included 98 patients with comorbid ED and PE, randomly assigned to the experimental group (n = 50, tadalafil alone) or the active control group (n = 48, tadalafil combined with lidocaine spray). Patients took tadalafil 30 min before sexual intercourse, while the combination therapy group also used lidocaine spray 5 min before intercourse. After 12 weeks of treatment, changes in the International Index of Erectile Function (IIEF-5), Chinese Index of Premature Ejaculation (CIPE-5), Intravaginal Ejaculatory Latency Time (IELT), and Sexual Satisfaction Score (SSS) were evaluated.
Results: Both groups showed significant improvement in IIEF-5 scores, but the difference between groups was not significant (F = 0.89, p = 0.45). The active control group showed significant improvement in CIPE-5 scores (p < 0.001), while the experimental group showed no significant change (p > 0.05). IELT in the active control group increased significantly from 25.7 s to 198.6 s (Z = 6.03, p < 0.001), while the experimental group showed no significant change (Z = 0.74, p = 0.46). SSS improved significantly in the active control group (p < 0.001) but not in the experimental group (p > 0.05). The incidence of adverse events was similar in both groups (14% vs 20.8%, p = 0.575).
Conclusion: Tadalafil combined with lidocaine spray is superior to tadalafil alone in improving symptoms, prolonging IELT, and enhancing sexual satisfaction in patients with comorbid ED and PE, with comparable safety. This combination therapy provides a new approach for improving treatment strategies for patients with comorbid ED and PE. Large-scale, multi-center randomized controlled trials are needed to further validate these findings.
背景：评价他达拉非单用20mg或联合利多卡因喷雾治疗伴发性勃起功能障碍（ED）和早泄（PE）患者的疗效和安全性。方法：随机对照试验98例合并ED和PE的患者，随机分为实验组（50例，单独使用他达拉非）和活性对照组（48例，他达拉非联合利多卡因喷雾）。患者在性交前30 min使用他达拉非，联合治疗组在性交前5 min使用利多卡因喷雾。治疗12周后，评估国际勃起功能指数（IIEF-5）、中国早泄指数（CIPE-5）、阴道内射精潜伏期（IELT）和性满意度评分（SSS）的变化。结果：两组患者IIEF-5评分均有显著改善，但组间差异无统计学意义（F = 0.89, p = 0.45）。积极对照组患者CIPE-5评分显著改善（p < 0.05）。积极对照组的雅思成绩由25.7 s显著提高至198.6 s （Z = 6.03, p Z = 0.74, p = 0.46）。活性对照组SSS明显改善（p < 0.05）。两组不良事件发生率相似（14% vs 20.8%, p = 0.575）。结论：他达拉非联合利多卡因喷雾剂在改善ED和PE合并症患者的症状、延长雅思考试时间、提高性满意度方面优于他达拉非单用，且安全性相当。这种联合治疗为改善ED和PE合并症患者的治疗策略提供了新的途径。需要大规模、多中心随机对照试验来进一步验证这些发现。
期刊介绍：
As the official journal of the World Association for Sexual Health, the International Journal of Sexual Health promotes sexual health as a state of physical, emotional, mental, and social well-being through a positive approach to sexuality and sexual rights. The journal publishes peer-reviewed scientific papers, editorials, and reviews, using quantitative and qualitative methods, descriptive and critical analysis, instrument development, surveys, and case studies to examine the essential elements of this broad concept. Leading experts from around the world present original work that covers a variety of disciplines, including sexology, biology, medicine, psychology, sociology, anthropology, history, and religion.
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