Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial

Abstract

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.

Outcome prediction of prostatic artery embolization: post hoc analysis of a randomized, open‐label, non‐inferiority trial

“…Nevertheless, PAE has come into use over the past years and was recently approved by the National Institute for Health and Care Excellence (NICE) as a minimally invasive approach for LUTS/BPH . Patient‐reported outcomes with PAE are similar to those for established surgical methods, and it has a better side‐effect profile but lower desobstructive efficacy . Because PAE is a very different therapeutic approach, outcome predictors for traditional transurethral surgical approaches are unlikely to be fully applicable to PAE.…”

“…Outcome predictors of PAE have barely been investigated and conflicting results require elucidation. The aim of the present study was to assess the variability of treatment outcomes in a patient cohort undergoing PAE within a randomized, open‐label, non‐inferiority trial and to identify patient characteristics and findings related to the intervention that might allow improved patient selection and early estimation of PAE outcomes.…”

Prostate artery embolisation for benign prostatic hyperplasia

“…The recent UK Register of Prostatic Embolisation (ROPE) study has shown its preliminary safety and efficacy in a multicentre observational evaluation, which also included an indirect comparison with TURP 3. This study follows other small randomised controlled trials suggesting some benefit of PAE over TURP,4 and in a linked article (doi:10.1136/bmj.k2338), a larger trial adds further detail to PAE’s ongoing evaluation 5…”

“…In their randomised, open label non-inferiority trial,5 Abt and colleagues included 103 men (48 receiving PAE and 51 receiving standard TURP) with moderate benign prostatic hyperplasia (mean gland size 50 mL), who were followed up for a limited 12 week period after their assigned treatment. The primary endpoint was change in international prostate symptom score (IPSS).…”

“…The procedure improves urinary symptoms, avoids surgery and its inherent risks (at least for the medium term), and could preserve normal ejaculation more than TURP 5. But it is impossible to know the true risk of recurrence from this 12 week trial.…”