Publication
Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia
| dc.contributor.author | Martins Pisco, J | |
| dc.contributor.author | Bilhim, T | |
| dc.contributor.author | Vasco Costa, N | |
| dc.contributor.author | Torres, D | |
| dc.contributor.author | Pisco, J | |
| dc.contributor.author | Campos Pinheiro, L | |
| dc.contributor.author | Gouveia Oliveira, A | |
| dc.date.accessioned | 2021-02-19T17:38:30Z | |
| dc.date.available | 2021-02-19T17:38:30Z | |
| dc.date.issued | 2020 | |
| dc.description.abstract | Background: Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. Objective: To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. Design, setting, and participants: A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. Intervention: Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. Outcome measurements and statistical analysis: An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. Results and limitations: Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. Conclusions: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Patient summary: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia. | pt_PT |
| dc.description.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.citation | Eur Urol. 2020 Mar;77(3):354-362. | pt_PT |
| dc.identifier.doi | 10.1016/j.eururo.2019.11.010 | pt_PT |
| dc.identifier.uri | http://hdl.handle.net/10400.17/3575 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.publisher | Elsevier | pt_PT |
| dc.subject | HCC IMA | pt_PT |
| dc.subject | CHLC URO | pt_PT |
| dc.subject | Aged | pt_PT |
| dc.subject | Arteries | pt_PT |
| dc.subject | Embolization, Therapeutic/methods | pt_PT |
| dc.subject | Lower Urinary Tract Symptoms/etiology | pt_PT |
| dc.subject | Lower Urinary Tract Symptoms/therapy | |
| dc.subject | Prostate/blood supply | |
| dc.subject | Prostatic Hyperplasia/complications | |
| dc.subject | Prostatic Hyperplasia/therapy | |
| dc.subject | Single-Blind Method | |
| dc.title | Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.endPage | 362 | pt_PT |
| oaire.citation.issue | 3 | pt_PT |
| oaire.citation.startPage | 354 | pt_PT |
| oaire.citation.title | European Urology | pt_PT |
| oaire.citation.volume | 77 | pt_PT |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |
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