ObjectiveTo compare prostatic artery embolisation (PAE) with transurethral resection of the prostate (TURP) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in terms of patient reported and functional outcomes.DesignRandomised, open label, non-inferiority trial.SettingUrology and radiology departments of a Swiss tertiary care centre.Participants103 patients aged ≥40 years with refractory lower urinary tract symptoms secondary to benign prostatic hyperplasia were randomised between 11 February 2014 and 24 May 2017; 48 and 51 patients reached the primary endpoint 12 weeks after PAE and TURP, respectively.InterventionsPAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia.Main outcomes and measuresPrimary outcome was change in international prostate symptoms score (IPSS) from baseline to 12 weeks after surgery; a difference of less than 3 points between treatments was defined as non-inferiority for PAE and tested with a one sided t test. Secondary outcomes included further questionnaires, functional measures, magnetic resonance imaging findings, and adverse events; changes from baseline to 12 weeks were compared between treatments with two sided tests for superiority.ResultsMean reduction in IPSS from baseline to 12 weeks was −9.23 points after PAE and −10.77 points after TURP. Although the difference was less than 3 points (1.54 points in favour of TURP (95% confidence interval −1.45 to 4.52)), non-inferiority of PAE could not be shown (P=0.17). None of the patient reported secondary outcomes differed significantly between treatments when tested for superiority; IPSS also did not differ significantly (P=0.31). At 12 weeks, PAE was less effective than TURP regarding changes in maximum rate of urinary flow (5.19 v 15.34 mL/s; difference 10.15 (95% confidence interval −14.67 to −5.63); P<0.001), postvoid residual urine (−86.36 v −199.98 mL; 113.62 (39.25 to 187.98); P=0.003), prostate volume (−12.17 v −30.27 mL; 18.11 (10.11 to 26.10); P<0.001), and desobstructive effectiveness according to pressure flow studies (56% v 93% shift towards less obstructive category; P=0.003). Fewer adverse events occurred after PAE than after TURP (36 v 70 events; P=0.003).ConclusionsThe improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia seen 12 weeks after PAE is close to that after TURP. PAE is associated with fewer complications than TURP but has disadvantages regarding functional outcomes, which should be considered when selecting patients. Further comparative study findings, including longer follow-up, should be evaluated before PAE can be considered as a routine treatment.Trial registrationClinicaltrials.gov NCT02054013.
contributed equally to this work.
ConclusionBaseline and peri-operative findings might help to guide patient selection and outcome prediction for PAE. Patients with larger prostates have a higher chance of success with PAE. Larger-scale clinical trials including a longer follow-up are warranted to further elucidate the most suitable patients for PAE.
Keywordsprostatic artery embolization, benign prostatic hyperplasia, prostate, minimally invasive, lower urinary tract symptoms, treatment effect, #UroBPH, #PAE, #LUTS
Purpose To assess the interreader variability of submillisievert CT for lung cancer screening in radiologists with various experience levels. Method Six radiologists with different degrees of clinical experience in radiology (range, 1-15 years), rated 100 submillisievert CT chest studies as either negative screening finding (no nodules, benign nodules, nodules <5 mm), indeterminate finding (nodules 5-10 mm), positive finding (nodules >10 mm). Each radiologist interpreted scans randomly ordered and reading time was recorded. Interobserver agreement was assessed with ak statistic. Reasons for differences in nodule classification were analysed on a case-by-case basis. Reading time was correlated with reader experience using Pearson correlation (r). Results The overall interobserver agreement between all readers was moderate (k = 0.454; p < 0.001). In 57 patients, all radiologists agreed on the differentiation of negative and indeterminate/positive finding. In 64 cases disagreement between readers led to different nodule classification. In 8 cases some readers rated the nodule as benign, whereas others scored the case as positive. Overall, disagreement in nodule classification was mostly due to failure in identification of target lesion (n = 40), different lesion measurement (n = 44) or different classification (n = 26). Mean overall reading time per scan was of 2 min 2 s (range: 7s-7 min 45 s) and correlated with reader-experience (r =-0.824). Conclusions Our study showed substantial interobserver variability for the detection and classification of pulmonary nodules in submillisievert CT. This highlights the importance for careful standardisation of screening programs with the objective of harmonizing efforts of involved radiologists across different institutions by defining and assuring quality standards.
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