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

BMJ Jun 29, 2018

Abt D, et al. - In this randomised, open label, non-inferiority trial, the researchers compared 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. They found that the improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia observed 12 weeks after PAE was close to that after TURP. Data reported that PAE was correlated with fewer complications than TURP but has disadvantages regarding functional outcomes, which ought to be considered while choosing subjects.

Methods
  • This trial was conducted at Urology and Radiology Departments of a Swiss tertiary care centre.
  • For the purpose of this investigation, 103 subjects 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 subjects reached the primary endpoint 12 weeks after PAE and TURP, respectively.
  • PAE performed with 250-400 μm microspheres under local anaesthesia vs monopolar TURP performed under spinal or general anaesthesia was the main intervention.
  • 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 was the primary outcome.
  • Further questionnaires, functional measures, magnetic resonance imaging findings, and adverse events were the included secondary outcomes.
  • Changes from baseline to 12 weeks were compared between treatments with two sided tests for superiority.

Results
  • According to the findings obtained, mean reduction in IPSS from baseline to 12 weeks was -9.23 points after PAE and -10.77 points after TURP.
  • Results revealed that 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).
  • It was noted that none of the patient reported secondary outcomes differed significantly between treatments when tested for superiority; IPSS also did not vary significantly (P=0.31).
  • Data reported that 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).
  • They discovered that fewer adverse events occurred after PAE than after TURP (36 v 70 events; P=0.003).
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