Associate Cochrane Centre, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea, South.
Cochrane Database Syst Rev. 2021 Jul 15;7(7):CD013656. doi: 10.1002/14651858.CD013656.pub2.
A variety of minimally invasive treatments are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). However, it is unclear which treatments provide better results.
Our primary objective was to assess the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH through a network meta-analysis. Our secondary objective was to obtain an estimate of relative ranking of these minimally invasive treatments, according to their effects.
We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Scopus, Web of Science and LILACS), trials registries, other sources of grey literature, and conference proceedings, up to 24 February 2021. We had no restrictions on language of publication or publication status.
We included parallel-group randomized controlled trials assessing the effects of the following minimally invasive treatments, compared to TURP or sham treatment, on men with moderate to severe LUTS due to BPH: convective radiofrequency water vapor therapy (CRFWVT); prostatic arterial embolization (PAE); prostatic urethral lift (PUL); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT).
Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model for pair-wise comparisons and a frequentist network meta-analysis for combined estimates. We interpreted them according to Cochrane methods. We planned subgroup analyses by age, prostate volume, and severity of baseline symptoms. We used risk ratios (RRs) with 95% confidence intervals (CIs) to express dichotomous data and mean differences (MDs) with 95% CIs to express continuous data. We used the GRADE approach to rate the certainty of evidence.
We included 27 trials involving 3017 men, mostly over age 50, with severe LUTS due to BPH. The overall certainty of evidence was low to very low due to concerns regarding bias, imprecision, inconsistency (heterogeneity), and incoherence. Based on the network meta-analysis, results for our main outcomes were as follows. Urologic symptoms (19 studies, 1847 participants): PUL and PAE may result in little to no difference in urologic symptoms scores (MD of International Prostate Symptoms Score [IPSS]) compared to TURP (3 to 12 months; MD range 0 to 35; higher scores indicate worse symptoms; PUL: 1.47, 95% CI -4.00 to 6.93; PAE: 1.55, 95% CI -1.23 to 4.33; low-certainty evidence). CRFWVT, TUMT, and TIND may result in worse urologic symptoms scores compared to TURP at short-term follow-up, but the CIs include little to no difference (CRFWVT: 3.6, 95% CI -4.25 to 11.46; TUMT: 3.98, 95% CI 0.85 to 7.10; TIND: 7.5, 95% CI -0.68 to 15.69; low-certainty evidence). Quality of life (QoL) (13 studies, 1459 participants): All interventions may result in little to no difference in the QoL scores, compared to TURP (3 to 12 months; MD of IPSS-QoL score; MD range 0 to 6; higher scores indicate worse symptoms; PUL: 0.06, 95% CI -1.17 to 1.30; PAE: 0.09, 95% CI -0.57 to 0.75; CRFWVT: 0.37, 95% CI -1.45 to 2.20; TUMT: 0.65, 95% CI -0.48 to 1.78; TIND: 0.87, 95% CI -1.04 to 2.79; low-certainty evidence). Major adverse events (15 studies, 1573 participants): TUMT probably results in a large reduction of major adverse events compared to TURP (RR 0.20, 95% CI 0.09 to 0.43; moderate-certainty evidence). PUL, CRFWVT, TIND and PAE may also result in a large reduction in major adverse events, but CIs include substantial benefits and harms at three months to 36 months; PUL: RR 0.30, 95% CI 0.04 to 2.22; CRFWVT: RR 0.37, 95% CI 0.01 to 18.62; TIND: RR 0.52, 95% CI 0.01 to 24.46; PAE: RR 0.65, 95% CI 0.25 to 1.68; low-certainty evidence). Retreatment (10 studies, 799 participants): We are uncertain about the effects of PAE and PUL on retreatment compared to TURP (12 to 60 months; PUL: RR 2.39, 95% CI 0.51 to 11.1; PAE: RR 4.39, 95% CI 1.25 to 15.44; very low-certainty evidence). TUMT may result in higher retreatment rates (RR 9.71, 95% CI 2.35 to 40.13; low-certainty evidence). Erectile function (six studies, 640 participants): We are very uncertain of the effects of minimally invasive treatments on erectile function (MD of International Index of Erectile Function [IIEF-5]; range 5 to 25; higher scores indicates better function; CRFWVT: 6.49, 95% CI -8.13 to 21.12; TIND: 5.19, 95% CI -9.36 to 19.74; PUL: 3.00, 95% CI -5.45 to 11.44; PAE: -0.03, 95% CI -6.38, 6.32; very low-certainty evidence). Ejaculatory dysfunction (eight studies, 461 participants): We are uncertain of the effects of PUL, PAE and TUMT on ejaculatory dysfunction compared to TURP (3 to 12 months; PUL: RR 0.05, 95 % CI 0.00 to 1.06; PAE: RR 0.35, 95% CI 0.13 to 0.92; TUMT: RR 0.34, 95% CI 0.17 to 0.68; low-certainty evidence). TURP is the reference treatment with the highest likelihood of being the most efficacious for urinary symptoms, QoL and retreatment, but the least favorable in terms of major adverse events, erectile function and ejaculatory function. Among minimally invasive procedures, PUL and PAE have the highest likelihood of being the most efficacious for urinary symptoms and QoL, TUMT for major adverse events, PUL for retreatment, CRFWVT and TIND for erectile function and PUL for ejaculatory function.
AUTHORS' CONCLUSIONS: Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and QoL compared to TURP at short-term follow-up. They may result in fewer major adverse events, especially in the case of PUL and PAE; resulting in better rankings for symptoms scores. PUL may result in fewer retreatments compared to other interventions, especially TUMT, which had the highest retreatment rates at long-term follow-up. We are very uncertain about the effects of these interventions on erectile function. There was limited long-term data, especially for CRFWVT and TIND. Future high-quality studies with more extended follow-up, comparing different, active treatment modalities, and adequately reporting critical outcomes relevant to patients, including those related to sexual function, could provide more information on the relative effectiveness of these interventions.
有多种微创治疗方法可作为经尿道前列腺切除术(TURP)的替代方法,用于治疗良性前列腺增生(BPH)男性的下尿路症状(LUTS)。然而,目前尚不清楚哪种治疗方法的效果更好。
我们的主要目的是通过网络荟萃分析评估治疗 BPH 男性 LUTS 的各种微创治疗方法的相对有效性。我们的次要目的是根据这些微创治疗方法的效果,估计它们的相对排名。
我们全面检索了多个数据库(CENTRAL、MEDLINE、Embase、Scopus、Web of Science 和 LILACS)、试验注册处、其他灰色文献来源和会议论文集,检索时间截至 2021 年 2 月 24 日。我们对发表语言或发表状态没有任何限制。
我们纳入了比较以下微创治疗方法与 TURP 或假手术治疗对中重度 BPH 导致的 LUTS 男性的效果的平行组随机对照试验:对流射频水蒸气治疗(CRFWVT);前列腺动脉栓塞术(PAE);前列腺尿道提升术(PUL);临时植入性镍钛诺装置(TIND);经尿道微波热疗(TUMT)。
两名综述作者独立筛选文献、提取数据并评估偏倚风险。我们使用随机效应模型进行两两比较的统计分析,并使用频率主义网络荟萃分析进行综合估计。我们根据 Cochrane 方法进行解释。我们计划按年龄、前列腺体积和基线症状严重程度进行亚组分析。我们使用比值比(RR)和 95%置信区间(CI)表示二分类数据,使用均数差值(MD)和 95%CI 表示连续数据。我们使用 GRADE 方法评估证据的确定性。
我们纳入了 27 项试验,涉及 3017 名男性,年龄大多在 50 岁以上,患有严重的 BPH 导致的 LUTS。由于对偏倚、不精确性、不一致性(异质性)和不连贯性的担忧,整体证据确定性为低至非常低。根据网络荟萃分析结果,我们主要结局的结果如下。下尿路症状(19 项研究,1847 名参与者):PUL 和 PAE 与 TURP 相比,可能对下尿路症状评分(国际前列腺症状评分[IPSS])没有差异或差异很小(3 至 12 个月;MD 范围 0 至 35;评分越高表示症状越严重;PUL:1.47,95%CI -4.00 至 6.93;PAE:1.55,95%CI -1.23 至 4.33;低确定性证据)。CRFWVT、TUMT 和 TIND 与 TURP 相比,在短期随访时可能会导致更差的下尿路症状评分,但 CI 包含无差异或差异很小(CRFWVT:3.6,95%CI -4.25 至 11.46;TUMT:3.98,95%CI 0.85 至 7.10;TIND:7.5,95%CI -0.68 至 15.69;低确定性证据)。生活质量(QoL)(13 项研究,1459 名参与者):与 TURP 相比,所有干预措施可能对 QoL 评分没有差异或差异很小(3 至 12 个月;IPSS-QoL 评分的 MD;MD 范围 0 至 6;评分越高表示症状越严重;PUL:0.06,95%CI -1.17 至 1.30;PAE:0.09,95%CI -0.57 至 0.75;CRFWVT:0.37,95%CI -1.45 至 2.20;TUMT:0.65,95%CI -0.48 至 1.78;TIND:0.87,95%CI -1.04 至 2.79;低确定性证据)。主要不良事件(15 项研究,1573 名参与者):与 TURP 相比,TUMT 可能会显著降低主要不良事件的发生率(RR 0.20,95%CI 0.09 至 0.43;中确定性证据)。PUL、CRFWVT、TIND 和 PAE 也可能会显著降低主要不良事件的发生率,但 CI 包含在 3 个月至 36 个月时的获益和危害;PUL:RR 0.30,95%CI 0.04 至 2.22;CRFWVT:RR 0.37,95%CI 0.01 至 18.62;TIND:RR 0.52,95%CI 0.01 至 24.46;PAE:RR 0.65,95%CI 0.25 至 1.68;低确定性证据)。再次治疗(10 项研究,799 名参与者):我们不确定 PAE 和 PUL 与 TURP 相比再次治疗的效果(12 至 60 个月;PUL:RR 2.39,95%CI 0.51 至 11.1;PAE:RR 4.39,95%CI 1.25 至 15.44;非常低确定性证据)。与 TURP 相比,TUMT 可能会导致更高的再次治疗率(RR 9.71,95%CI 2.35 至 40.13;低确定性证据)。勃起功能(六项研究,640 名参与者):我们非常不确定微创治疗对勃起功能的影响(国际勃起功能指数[IIEF-5]的 MD;范围 5 至 25;评分越高表示功能越好;CRFWVT:6.49,95%CI -8.13 至 21.12;TIND:5.19,95%CI -9.36 至 19.74;PUL:3.00,95%CI -5.45 至 11.44;PAE:-0.03,95%CI -6.38 至 6.32;非常低确定性证据)。射精功能障碍(八项研究,461 名参与者):与 TURP 相比,我们不确定 PUL、PAE 和 TUMT 对射精功能障碍的影响(3 至 12 个月;PUL:RR 0.05,95%CI 0.00 至 1.06;PAE:RR 0.35,95%CI 0.13 至 0.92;TUMT:RR 0.34,95%CI 0.17 至 0.68;低确定性证据)。TURP 是参考治疗方法,最有可能成为治疗尿路症状、生活质量和再次治疗的最有效方法,但在主要不良事件、勃起功能和射精功能方面最不利。在微创治疗方法中,PUL 和 PAE 最有可能在治疗尿路症状和生活质量方面效果最好,TUMT 最有可能降低主要不良事件的发生率,PUL 最有可能降低再次治疗的发生率,CRFWVT 和 TIND 最有可能改善勃起功能,PUL 最有可能改善射精功能。
与 TURP 相比,微创治疗方法在短期随访时可能会导致类似或更差的下尿路症状和生活质量,但在主要不良事件方面可能会有更好的效果,从而导致更好的症状评分排名。PUL 和 PAE 可能会降低主要不良事件的发生率,尤其是 PUL 与其他干预措施相比,尤其是与 TUMT 相比,TUMT 的再次治疗率最高。我们非常不确定这些干预措施对勃起功能的影响。关于这些干预措施的长期数据有限,尤其是关于 CRFWVT 和 TIND 的数据。未来高质量的研究,包括更多不同的、活跃的治疗方法,以及充分报告与患者相关的关键结局,包括与性功能相关的结局,可能会提供更多关于这些干预措施相对有效性的信息。