Hwang Eu Chang, Jung Jae Hung, Borofsky Michael, Kim Myung Ha, Dahm Philipp
Department of Urology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Korea, South.
Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD013143. doi: 10.1002/14651858.CD013143.pub2.
New, minimally invasive surgeries have emerged as alternatives to transurethral resection of the prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Aquablation is a novel, minimally invasive, water-based therapy, combining image guidance and robotics for the removal of prostatic tissue.
To assess the effects of Aquablation for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.
We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 11 February 2019, with no restrictions on the language or status of publication.
We included parallel-group randomised controlled trials (RCTs) and cluster-RCTs, as well as non-randomised observational prospective studies with concurrent comparison groups in which participants with BPH who underwent Aquablation.
Two review authors independently assessed studies for inclusion at each stage, and undertook data extraction and 'Risk of bias' and GRADE assessments of the certainty of the evidence. We considered review outcomes measured up to and including 12 months after randomisation as short-term and beyond 12 months as long-term.
We included one RCT with 184 participants comparing Aquablation to TURP. The mean age and International Prostate Symptom Score were 65.9 years and 22.6, respectively. The mean prostate volume was 53.2 mL. We only found short-term data for all outcomes based on a single randomised trial.Primary outcomesUp to 12 months, Aquablation likely results in a similar improvement in urologic symptom scores to TURP (mean difference (MD) -0.06, 95% confidence interval (CI) -2.51 to 2.39; participants = 174; moderate-certainty evidence). We downgraded the evidence certainty by one level due to study limitations. Aquablation may also result in similar quality of life when compared to TURP (MD 0.27, 95% CI -0.24 to 0.78; participants = 174, low-certainty evidence). We downgraded the evidence certainty by two levels due to study limitations and imprecision. Aquablation may result in little to no difference in major adverse events (risk ratio (RR) 0.84, 95% CI 0.31 to 2.26; participants = 181, very low-certainty evidence) but we are very uncertain of this finding. This would correspond to 15 fewer major adverse events per 1000 participants (95% CI 64 fewer to 116 more). We downgraded the evidence certainty by one level for study limitations and two levels for imprecision.Secondary outcomesUp to 12 months, Aquablation may result in little to no difference in retreatments (RR 1.68, 95% CI 0.18 to 15.83; participants = 181, very low-certainty evidence) but we are very uncertain of this finding. This would correspond to 10 more retreatments per 1000 participants (95% CI 13 fewer to 228 more). We downgraded the evidence certainty by one level due to study limitations and two levels for imprecision.Aquablation may result in little to no difference in erectile function as measured by International Index of Erectile Function questionnaire Erectile Function domain compared to TURP (MD 2.31, 95% CI -0.63 to 5.25; participants = 64, very low-certainty evidence), and may cause slightly less ejaculatory dysfunction than TURP, as measured by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MD 2.57, 95% CI 0.60 to 4.53; participants = 121, very low-certainty evidence). However, we are very uncertain of both findings. We downgraded the evidence certainty by two levels due to study limitations and one level for imprecision for both outcomes.We did not find other prospective, comparative studies comparing Aquablation to TURP or other procedures such as laser ablation, enucleation, or other minimally invasive therapies.
AUTHORS' CONCLUSIONS: Based on short-term (up to 12 months) follow-up, the effect of Aquablation on urological symptoms is probably similar to that of TURP (moderate-certainty evidence). The effect on quality of life may also be similar (low-certainty evidence). We are very uncertain whether patients undergoing Aquablation are at higher or lower risk for major adverse events (very low-certainty evidence). We are very uncertain whether Aquablation may result in little to no difference in erectile function but offer a small improvement in preservation of ejaculatory function (both very low-certainty evidence). These conclusions are based on a single study of men with a prostate volume up to 80 mL in size. Longer-term data and comparisons with other modalities appear critical to a more thorough assessment of the role of Aquablation for the treatment of LUTS in men with BPH.
新型微创手术已成为经尿道前列腺切除术(TURP)的替代方案,用于治疗良性前列腺增生(BPH)男性的下尿路症状(LUTS)。水消融术是一种新型的微创水基疗法,结合图像引导和机器人技术来切除前列腺组织。
评估水消融术治疗良性前列腺增生男性下尿路症状的效果。
我们使用多个数据库(Cochrane图书馆、MEDLINE、Embase、Scopus、科学引文索引和拉丁美洲及加勒比地区卫生科学数据库)、试验注册库、其他灰色文献来源以及截至2019年2月11日发表的会议论文进行了全面检索,对语言或出版状态没有限制。
我们纳入了平行组随机对照试验(RCT)和整群RCT,以及具有同期比较组的非随机观察性前瞻性研究,其中接受水消融术的BPH参与者。
两位综述作者在每个阶段独立评估纳入研究,并进行数据提取以及对证据确定性的“偏倚风险”和GRADE评估。我们将随机分组后直至并包括12个月的综述结果视为短期结果,超过12个月的视为长期结果。
我们纳入了一项有184名参与者的RCT,比较水消融术与TURP。平均年龄和国际前列腺症状评分分别为65.9岁和22.6。平均前列腺体积为53.2 mL。基于单个随机试验,我们仅找到了所有结果的短期数据。
主要结局
在12个月内,水消融术可能导致泌尿系统症状评分的改善与TURP相似(平均差值(MD)-0.06,95%置信区间(CI)-2.51至2.39;参与者 = 174;中等确定性证据)。由于研究局限性,我们将证据确定性下调了一个等级。与TURP相比,水消融术可能也会带来相似的生活质量(MD 0.27,95% CI -0.24至0.78;参与者 = 174,低确定性证据)。由于研究局限性和不精确性,我们将证据确定性下调了两个等级。水消融术可能导致主要不良事件几乎没有差异(风险比(RR)0.84,95% CI 0.31至2.26;参与者 = 181,极低确定性证据),但我们对此发现非常不确定。这相当于每千名参与者中主要不良事件减少15例(95% CI减少64例至增加116例)。由于研究局限性,我们将证据确定性下调了一个等级,由于不精确性下调了两个等级。
次要结局
在12个月内,水消融术可能导致再次治疗几乎没有差异(RR 1.68,95% CI 0.18至15.83;参与者 = 181,极低确定性证据),但我们对此发现非常不确定。这相当于每千名参与者中再次治疗增加10例(95% CI减少13例至增加228例)。由于研究局限性,我们将证据确定性下调了一个等级,由于不精确性下调了两个等级。
与TURP相比,根据国际勃起功能指数问卷勃起功能领域测量,水消融术可能导致勃起功能几乎没有差异(MD 2.31,95% CI -0.63至5.25;参与者 = 64;极低确定性证据),并且根据射精功能障碍男性性健康问卷测量,可能导致射精功能障碍比TURP略少(MD 2.57,95% CI 0.60至4.53;参与者 = 121,极低确定性证据)。然而,我们对这两个发现都非常不确定。由于研究局限性,我们将这两个结局的证据确定性下调了两个等级,由于不精确性下调了一个等级。
我们未找到其他将水消融术与TURP或其他手术(如激光消融、剜除术或其他微创疗法)进行比较的前瞻性、对照研究。
基于短期(长达12个月)随访,水消融术对泌尿系统症状的影响可能与TURP相似(中等确定性证据)。对生活质量的影响可能也相似(低确定性证据)。我们非常不确定接受水消融术的患者发生主要不良事件的风险是更高还是更低(极低确定性证据)。我们非常不确定水消融术是否可能导致勃起功能几乎没有差异,但在保留射精功能方面有小幅改善(两者均为极低确定性证据)。这些结论基于对前列腺体积最大达80 mL男性的单项研究。更长期的数据以及与其他方式的比较对于更全面评估水消融术在治疗BPH男性LUTS中的作用似乎至关重要。