Background: 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. Objectives: 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. Search methods: 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. Selection criteria: 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). Data collection and analysis: 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. Main results: 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.
Bibliographical noteFunding Information:
Grant from the research committee of St Gallen Cantonal Hospital
This study was supported by a grant from Urologix Inc.
Drs Speakman, Berges, Sievert, and Sønksen reported grants from NeoTract, Inc.
The study was supported by a grant from Vejle County, Denmark.
Fourteen studies did not state their funding sources (Ahmed 1997;?Albala 2002;?Bdesha 1994;?Blute 1996;?Brehmer 1999;?Carnevale 2016;?D'Ancona 1998;?Dahlstrand 1995;?De Wildt 1996;?Floratos 2001;?Gao 2014;?Radwan 2020;?Venn 1995;?Zhu 2018), nine studies were funded by the manufacturers or sponsors of the procedure (Chughtai 2020;?Gratzke 2017;?Insausti 2020;?Larson 1998;?McVary 2016;?Pisco 2020;?Roehrborn 1998;?Roehrborn 2013;?Wagrell 2002) and four studies were funded by public institutions or hospitals (Nawrocki 1997;?Norby 2002;?Abbou 1995;?Abt 2018). We are very grateful to Cochrane Urology, especially Assistant Managing Editor Jenn Mariano, as well as Cochrane Urology Korea, for supporting this review. We are also grateful for the constructive feedback from the Cancer Network and the Methods Support Unit. We also thank the following individuals: Gretchen Kuntz for revising and providing feedback on the search strategies Marco Blanker, Sevann Helo, and Murad Mohammad for their peer review input of the protocol. Dominik Abt, Bilal Chughtai, and Ahmed Higazy for providing details on the outcomes of their trials, for them to be incorporated accurately in our review. Marc Sapoval, Deepak Agarwal, Cameron Alexander, Harris Foster, and Mitchell Humphreys for their peer review input of the review. Gretchen Kuntz for revising and providing feedback on the search strategies Marco Blanker, Sevann Helo, and Murad Mohammad for their peer review input of the protocol. Dominik Abt, Bilal Chughtai, and Ahmed Higazy for providing details on the outcomes of their trials, for them to be incorporated accurately in our review. Marc Sapoval, Deepak Agarwal, Cameron Alexander, Harris Foster, and Mitchell Humphreys for their peer review input of the review. Juan V?ctor Ariel Franco is a PhD candidate in the Programme of Methodology of Biomedical Research and Public Health, Universitat Aut?noma de Barcelona (Spain).
Partially funded by an unrestricted grant from BTG plc (London, UK).
This study was supported by a grant from the Comite d’Evaluation et de Diffusion des Innovations Technologiques (CEDIT), Assistance Publique-Hopitaux de Paris. Devices were lent by the following companies: Biodan, Brucker, BSD, Direx, and Tecnomatix.
LORS grant from the South East Thames Regional Research Committee.
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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