Abstract：
BACKGROUND: In recent years, there has been growing interest in the use of hyaluronic acid (HA) for the treatment of premature ejaculation (PE). The efficacy of this treatment is quite controversial.
OBJECTIVE: This study intended to evaluate the efficacy and safety of glans penis augmentation with HA gel for PE.
METHODS: This systematic review includes randomized controlled trials (RCTs), primary clinical trials, prospective and retrospective studies, case series, and case reports. Searches in Embase, PubMed, Cochrane, Web of Knowledge, and ClinicalTrials.gov were performed blindly by 2 reviewers.
RESULTS: Intravaginal ejaculation latency time (IELT), questionnaires about PE, glans circumference (millimeters), and adverse events.
RESULTS: Thirteen studies were included in the evaluation: 4 RCTs, 8 prospective observational studies, and 1 restrospective study. The number of patients who received HA gel on the glans penis was 706. According to the results of 2 placebo-controlled RCTs, HA gel treatment significantly improved IELT at the end of the first month (mean difference [MD], 65.44 seconds). In the first month after the HA gel injection procedure, IELT increased vs before the procedure (MD, 176.18 [95% CI, 146.89-205.48]; P < .001, I2 = 83%). When the IELT values were compared at 6 months after HA gel application, IELT improved vs before the procedure (MD, 143.93 [95% CI, 124.78-163.09]; P < .001, I2 = 82). The glans circumference expanded by approximately 1.5 cm after the procedure (MD, 14.82 mm [95% CI, 12.75-16.90]; P < .001, I2 = 65%). When the side effect profile of other studies was examined, side effects were observed in 91 patients after HA gel injection applied to 598 patients (15.22%). Among these side effects, the most common were pain (n = 46, 7.69%), bulla/nodule formation (n = 25, 4.18%), and ecchymosis (n = 20, 3.34%).
CONCLUSIONS: While HA shows promise as a therapeutic option for PE, ongoing research is essential to elucidate its clinical utility, mechanisms of action, and comparative efficacy.
OBJECTIVE: This study intended to evaluate the efficacy and safety of glans penis augmentation with HA gel for PE.
METHODS: This systematic review includes randomized controlled trials (RCTs), primary clinical trials, prospective and retrospective studies, case series, and case reports. Searches in Embase, PubMed, Cochrane, Web of Knowledge, and ClinicalTrials.gov were performed blindly by 2 reviewers.
RESULTS: Intravaginal ejaculation latency time (IELT), questionnaires about PE, glans circumference (millimeters), and adverse events.
RESULTS: Thirteen studies were included in the evaluation: 4 RCTs, 8 prospective observational studies, and 1 restrospective study. The number of patients who received HA gel on the glans penis was 706. According to the results of 2 placebo-controlled RCTs, HA gel treatment significantly improved IELT at the end of the first month (mean difference [MD], 65.44 seconds). In the first month after the HA gel injection procedure, IELT increased vs before the procedure (MD, 176.18 [95% CI, 146.89-205.48]; P < .001, I2 = 83%). When the IELT values were compared at 6 months after HA gel application, IELT improved vs before the procedure (MD, 143.93 [95% CI, 124.78-163.09]; P < .001, I2 = 82). The glans circumference expanded by approximately 1.5 cm after the procedure (MD, 14.82 mm [95% CI, 12.75-16.90]; P < .001, I2 = 65%). When the side effect profile of other studies was examined, side effects were observed in 91 patients after HA gel injection applied to 598 patients (15.22%). Among these side effects, the most common were pain (n = 46, 7.69%), bulla/nodule formation (n = 25, 4.18%), and ecchymosis (n = 20, 3.34%).
CONCLUSIONS: While HA shows promise as a therapeutic option for PE, ongoing research is essential to elucidate its clinical utility, mechanisms of action, and comparative efficacy.
摘要：
背景：近年来，越来越多的人对使用透明质酸(HA)治疗早泄(PE)感兴趣。这种治疗的疗效相当有争议。
目的：本研究旨在评估HA凝胶用于PE的龟头扩张的有效性和安全性。
方法：本系统综述包括随机对照试验（RCT），初级临床试验,前瞻性和回顾性研究，案例系列,和病例报告。在Embase中搜索,PubMed,科克伦,WebofKnowledge,和ClinicalTrials.gov是由两名评论者盲目执行的。
结果：阴道内射精潜伏期（IELT），关于体育的问卷调查，龟头周长（毫米），和不良事件。
结果：评估包括13项研究：4项随机对照试验，8项前瞻性观察性研究，和1项回顾性研究。在龟头上接受HA凝胶的患者人数为706。根据2项安慰剂对照随机对照试验的结果，在第一个月末，HA凝胶治疗显着改善了IELT（平均差异[MD]，65.44秒）。在HA凝胶注射程序后的第一个月，IELT与手术前相比增加(MD，176.18[95%CI，146.89-205.48]；P<.001，I2=83%）。当在HA凝胶应用后6个月比较IELT值时，IELT与手术前相比有所改善(MD，143.93[95%CI，124.78-163.09]；P<.001，I2=82）。手术后，龟头周长扩大了约1.5厘米（MD，14.82mm[95%CI，12.75-16.90]；P<.001，I2=65%）。当检查其他研究的副作用时，对598例患者应用HA凝胶注射后，91例患者观察到副作用(15.22%)。在这些副作用中，最常见的是疼痛（n=46，7.69％），大疱/结节形成（n=25，4.18％），和瘀斑（n=20，3.34％）。
结论：虽然HA有望作为PE的治疗选择，正在进行的研究对于阐明其临床实用性至关重要，行动机制,和比较功效。
目的：本研究旨在评估HA凝胶用于PE的龟头扩张的有效性和安全性。
方法：本系统综述包括随机对照试验（RCT），初级临床试验,前瞻性和回顾性研究，案例系列,和病例报告。在Embase中搜索,PubMed,科克伦,WebofKnowledge,和ClinicalTrials.gov是由两名评论者盲目执行的。
结果：阴道内射精潜伏期（IELT），关于体育的问卷调查，龟头周长（毫米），和不良事件。
结果：评估包括13项研究：4项随机对照试验，8项前瞻性观察性研究，和1项回顾性研究。在龟头上接受HA凝胶的患者人数为706。根据2项安慰剂对照随机对照试验的结果，在第一个月末，HA凝胶治疗显着改善了IELT（平均差异[MD]，65.44秒）。在HA凝胶注射程序后的第一个月，IELT与手术前相比增加(MD，176.18[95%CI，146.89-205.48]；P<.001，I2=83%）。当在HA凝胶应用后6个月比较IELT值时，IELT与手术前相比有所改善(MD，143.93[95%CI，124.78-163.09]；P<.001，I2=82）。手术后，龟头周长扩大了约1.5厘米（MD，14.82mm[95%CI，12.75-16.90]；P<.001，I2=65%）。当检查其他研究的副作用时，对598例患者应用HA凝胶注射后，91例患者观察到副作用(15.22%)。在这些副作用中，最常见的是疼痛（n=46，7.69％），大疱/结节形成（n=25，4.18％），和瘀斑（n=20，3.34％）。
结论：虽然HA有望作为PE的治疗选择，正在进行的研究对于阐明其临床实用性至关重要，行动机制,和比较功效。
