Microwave thermotherapy for benign prostatic hyperplasia with the dornier urowave: Results of a randomized, double-blind, multicenter, sham-controlled trial
Microwave thermotherapy for benign prostatic hyperplasia with the dornier urowave: Results of a randomized, double-blind, multicenter, sham-controlled trial
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DOI：
10.1016/s0090-4295(98)00051-x
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发表时间：
1998-01-01
期刊：
影响因子：
2.1
通讯作者：
Womack, S
中科院分区：
文献类型：
--
作者：
Roehrborn, CG;Preminger, G;Womack, S
在此之前，前列腺大小在良性前列腺增生症(BPH)的治疗选择中并不起重要作用。据推测，前列腺大小与症状严重程度、尿流率或有无梗阻无关。然而，在一项发表的对社区男性的研究中，前列腺肥大的男性出现中度到重度症状的几率是正常前列腺男性的五倍。对某些类型的BPH治疗的反应，特别是非那雄胺，取决于实际的前列腺体积。因此，有一种简单的方法来准确地确定患者的前列腺是否增大是很重要的。在对四项研究的分析中，与经直肠超声(TRUS)测量相比，直肠指诊(DRE)明显低估了前列腺大小。对前列腺体积的低估随着TRUS体积的增加而增加，特别是当体积大于30mT时。对于30到39毫升的前列腺体积，平均低估了9%到12%，对于40到49毫升的前列腺体积，平均低估了17%到27%。由于这些结果，目前正在进行一项前瞻性研究，以开发模型或视觉辅助工具，以帮助医生通过DRE更准确地预测阈值前列腺体积。(C)1998，Elsevier Science Inc.保留所有权利。目的：通过随机、双盲、假对照试验，研究新型经尿道微波热疗机(Urowave)治疗男性临床良性前列腺增生症(BPH)的疗效和安全性。纳入2 2 0例(平均年龄6 6.2岁)临床BPH患者，美国泌尿系协会症状指数(AUA SI)≥13分，峰值尿流率<12 m L/S，随机分为2：1治疗组和假治疗组。所有治疗都是在局部麻醉下作为门诊程序进行的，仅使用口服镇静和止痛。分别于治疗后1周、1、3、6个月进行随访。这些治疗耐受性良好，没有患者接受全身或脊柱麻醉。6个月时AUA SI由23.6分降至12.7分(P
Previously, prostate size did not play a significant role in the choice of treatment for benign prostatic hyperplasia (BPH). It has been postulated that prostate size does not correlate with symptom severity, flow rate, or the presence or absence of obstruction. However, in a published study of community-dwelling men, the odds of having moderate to severe symptoms were five times higher for men with enlarged prostates than for those with normal prostates. Response to certain types of BPH therapy, especially finasteride, depends on actual prostate volume. Therefore, it is important to have a simple way to accurately determine if a patient's prostate is enlarged. In an analysis of four studies, there was a distinct underestimation of prostate size by digital rectal examination (DRE) when compared with transrectal ultrasound (TRUS) measurement. The underestimation of prostate volume increased with increasing TRUS volume, particularly if the volume was greater than 30 mt. The average underestimation was between 9% and 12% for prostate volumes 30 to 39 mt and between 17% and 27% for prostate volumes 40 to 49 mL. Because of these results, a prospective study is currently in progress to develop models or visual aids to assist physicians in more accurately predicting a threshold prostate volume via DRE. (C) 1998, Elsevier Science Inc. All rights reserved.Objectives. To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of men with clinical benign prostatic hyperplasia (BPH) in a randomized, double-blind, sham-controlled trial.Methods. A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association symptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure under local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment.Results. The treatments were well tolerated, and no patient received general or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P