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

Abstract

Objective: To 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.

Design: Randomised, open label, non-inferiority trial.

Setting: Urology and radiology departments of a Swiss tertiary care centre.

Participants: 103 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.

Interventions: PAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia.

Main outcomes and measures: Primary 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.

Results: Mean 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).

Conclusions: The 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 registration: Clinicaltrials.gov NCT02054013.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from St Gallen Cantonal Hospital for the submitted work; no financial relationship with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Fig 1

Study enrolment and randomisation (CONSORT flow diagram)

Fig 2

Primary outcome and patient reported secondary outcomes in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia receiving prostatic artery embolisation (PAE) or transurethral resection of the prostate (TURP). (A) Improvements in the international prostate symptom score (IPSS) after PAE and TURP. (B) Mean difference in IPSS (primary efficacy endpoint) between treatment groups. Secondary endpoints between PAE and TURP for (C) IPSS related quality of life (QoL); (D) chronic prostatitis symptoms index (CPSI) assessing pain, urinary symptoms, and quality of life; and (E) international index of erectile function (IIEF). I bars in (A, C, D, E) indicate 95% confidence intervals. Boxes in (B) show the interquartile range, with central lines indicating the median. Each whisker extends to the most extreme data point, which deviates no more than 1.5 times the interquartile range from the box. Points indicate observations, which lie beyond the extremes of the whiskers. Preop=before the operation (that is, baseline). P values (apart from part B) are reported for differences of change from baseline between both treatments. Means are calculated from the complete dataset at each visit. Occasional missing values for parts (D) and (E) cause slight differences between the mean change from baseline to a follow-up visit and the difference between mean values at individual time points reported in the text

Fig 3

Functional secondary outcome parameters in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia receiving prostatic artery embolisation (PAE) or transurethral resection of the prostate (TURP). Parameters include (A) maximum urinary flow rate, (B) postvoid residual urine, (C) concentrations of prostate specific antigen (PSA), (D) Prostate volume reduction as assessed by magnetic resonance imaging, (E) desobstruction as measured by detrusor pressure at maximum flow rate (PdetQmax), and (F) urodynamic obstruction as measured by International Continence Society (ICS) classification. I bars=95% confidence intervals; dots=means calculated from the complete dataset at each visit. P values are reported for differences of change from baseline between both treatments. Preop=before the operation (that is, baseline); postop=after the operation. Occasional missing values for secondary outcomes may cause the mean change from baseline to a follow-up visit in (parts A-E) to differ slightly from the difference between mean values at individual time points reported in the text

Fig 4

Frequency of treatment related adverse events, postoperative pain, and ejaculatory disorders in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia receiving prostatic artery embolisation (PAE) or transurethral resection of the prostate (TURP). VAS=visual analogue scale (≥6 points=severe pain). Postoperative pain during hospital stay and ejaculatory disorders were not defined as deviation from the normal postoperative course; therefore, these events were not included in the total number of adverse events but assessed separately