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目的:探讨射频治疗膀胱过度活动症(OAB)的有效性和安全性。方法:本研究采用前瞻性、多中心、非随机对照的试验方法。选择2019年3月至2020年6月浙江省人民医院、温州医科大学附属第一医院、浙江大学医学院附属邵逸夫医院符合条件的患者。纳入标准：符合OAB诊断的成年患者，膀胱容量>100 ml。排除标准：怀孕及哺乳期妇女；具有尿路梗阻等继发性OAB症状者；合并有1周内未控制的泌尿系感染者；应用其他方法治疗已处于稳定期者；体内已植入神经刺激器、心脏起搏器、植入式除颤器者；存在恶性肿瘤、肾功能不全或严重心脑血管疾病者；近12个月内接受过肉毒毒素治疗者。将患者按就诊时间顺序，以2∶1比例分配到试验组和对照组。试验组患者分别于第1、2、7、8周进行射频治疗，共治疗4次。对照组在射频治疗过程中将能量设为"关"状态。两组患者从第1次治疗开始每周进行随访，直至第12周结束随访。末次随访时，记录两组治疗成功率[24 h排尿次数较基线减少≥50%或恢复正常(≤8次/d)，或24 h尿急次数较基线减少≥50%]，以及两组治疗后的排尿次数、尿急次数、夜尿次数、膀胱残余尿量、生活质量评分(QOL)、导管相关不良事件。比较两组治疗成功率及治疗前后上述指标变化。结果:共入组114例，其中试验组76例，对照组38例。两组患者年龄[(44.2±12.8)岁与(41.7±12.1)岁]、性别(男/女：13/63与4/34)、病程[2.0(1.2，5.0)年与2.0(1.0，4.0)年]，以及治疗前排尿次数[12.8(10.6，16.8)次与12.8(10.3，17.0)次]、尿急次数[11.8 (9.3，15.8)次与11.8 (9.0，17.0)次]、夜尿次数[2.7 (1.3，3.7)次与2.3 (0.7，3.3)次]、膀胱残余尿量[12.0(3.0，28.0)ml与14.0(3.7，20.0)ml]和QOL[5.0(4.0，5.0)分与4.0(4.0，5.0)分]差异均无统计学意义( P>0.05)。试验组治疗成功率为76.3%(58/76)，对照组治疗成功率为26.3%(10/38)，差异有统计学意义( χ2＝24.70， P <0.01)。治疗后试验组较对照组的排尿次数[9.7(7.7，12.0)次与12.9(9.6，15.7)次]、尿急次数[7.3 (5.0，10.0)次与11.7 (7.3，15.3)次]、夜尿次数[1.3 (0.7，2.0)次与1.67 (1.0，3.0)次]和QOL[3.0(1.0，3.0)分与4.0(3.0，4.5)分]均明显降低，差异有统计学意义( P<0.05)；两组残余尿量[0 (0，10.0)ml与1.4(0，10.0)ml]差异无统计学意义( P>0.05)。试验组患者治疗后排尿次数、尿急次数、夜尿次数、残余尿量和QOL均较治疗前有明显改善( P<0.05)；对照组患者治疗后排尿次数、夜尿次数、残余尿量和QOL较治疗前有改善( P<0.05)。两组共13例(11.4%)出现导管相关不良事件。试验组与对照组置入器械导致出血(5/76与2/38)、3d内急性泌尿系感染(3/76与2/38)和器械断裂(0与1/38)发生率差异均无统计学意义( P>0.05)。 结论:射频治疗OAB能有效改善患者症状，提高患者生活质量，不良事件发生率较低，具有良好的疗效和安全性。

Objective:To explore the safety and efficacy of radiofrequency in the treatment of overactive bladder(OAB).Methods:A prospective, multicenter, non-randomized controlled trial was conducted. Eligible patients were divided into test group and control group in Zhejiang Provincial People’Hospital, The First Affiliated Hospital of Wenzhou Medical University, and Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine from March 2019 to June 2020. Inclusion criteria: patients diagnosed with OAB, and bladder capacity>100ml. Exclusion criteria: pregnant and lactating women; patients with secondary OAB symptoms such as urinary tract obstruction; patients with uncontrolled urinary tract infection within 1 week; patients in stable stage by using other treatment methods; patients implanted with any nerve stimulator, cardiac pacemaker or implantable defibrillator; patients with malignant tumors, serious cardiovascular, cerebrovascular diseases, renal insufficiency or received BTX treatment in recent 12 months. The patients were allocated to test group and the control group in a ratio of 2∶1 according to the time sequence of the visit. The patients in the test group were treated with radiofrequency treatment. After entering the group, they were treated for 4 times at the 1st, 2nd, 7th and 8th week respectively. In the control group, the energy was turned off during the radiofrequency treatment. The patients were followed-up every week until the end of the 12th week. The treatment success rate [the average frequency of urination in 24 h was reduced more than 50% from the baseline or returned to the normal (≤8 times/day) or the average frequency of urgent urination in 24 h was reduced more than 50% from the baseline], the frequency of urination, urgent urination and nocturnal urination before and after treatment, the residual urine volume of the bladder, the quality of life (QOL) score and the occurrence of catheter related adverse events in two groups were compared.Results:114 patients were enrolled in the study, including 76 patients in the test group and 38 patients in the control group. There were no significant differences in the age [(44.2±12.8) vs. (41.7 ± 12.1) years old], male female ratio (13/63 vs. 4/34), average course of disease [2.0(1.2, 5.0) vs. 2.0 (1.0, 4.0) years], the frequency of urination[12.8 (10.6, 16.8) vs. 12.8 (10.3, 17.0) times], urgency urination [11.8(9.3, 15.8) vs. 11.8 (9.0, 17.0) times], nocturia [2.7 (1.3, 3.7) vs. 2.3(0.7, 3.3) times], residual urine volume of bladder [12.0 (3.0, 28.0) vs. 14.0 (3.7, 20.0) ml ] and the QOL score [5.0(4.0, 5.0) vs. 4.0(4.0, 5.0)]before the treatment between the two groups ( P>0.05). The treatment success rate in the test group was 76.3% (58/76), while 26.3% (10/38) in the control group, with a statistically significant difference ( P<0.01). There were significant differences between the test group and control group in the frequency of urination [9.7 (7.7, 12.0) vs. 12.9 (9.6, 15.7) times], urgent urination [7.3 (5.0, 10.0) vs. 11.7 (7.3, 15.3) times], nocturia [1.3 (0.7, 2.0) vs. 1.7 (1.0, 3.0) times] and the QOL score of the patients[3.0(1.0, 3.0) vs. 4.0(3.0, 4.5)]after the treatment(all P<0.05). The frequency of urination, urgency urination, nocturia, the residual urine volume and the QOL score in the test group were significantly improved ( P<0.05) after the treatment.The frequency of urination, nocturia, residual urine volume and the QOL score in the control group were improved ( P<0.05) after the treatment. 13 (11.4%) patients had catheter related adverse events. In the test group and the control group, there were 7 cases of macroscopic hemorrhage caused by the placement of instruments (5/76 vs. 2/38), 5 cases of acute urinary tract infection within 3 days (3/76 vs. 2/38), and 1 case of instrument breakage (catheter breakage) (0/76 vs. 1/38). There were no significant differences in the adverse events between the two groups ( P> 0.05). Conclusions:Radiofrequency treatment of OAB can effectively improve the symptoms of patients, improve the QOL of patients, and has low incidence of adverse events, with good efficacy and safety.