Purpose: PAE requires slow injection of diluted calibrated microparticules, because BPH is not hypervascular. This results in prolonged injection time and consequent radiation exposure to the patient and staff, although there is no evidence that the injection rate might influence the clinical outcome. The purpose of this study was to compare 2 protocols of injection in patients undergoing PAE for bothersome LUTS.
Material and Methods: Between 8-2018 and 5-2019, 65 consecutive patients (mean age 66.0 years old ; mean PV 99.7± 49.7 ml, mean IPSS 20.0±6.4, Mean QoL 5.2±1.2) underwent PAE with calibrated diluted micro-particules (Embosphere 300-500) using previously described technique (end point: total occlusion of the PA) They were prospectively randomized between protocol A (named "slow") in which each single ml of particles injection was separated by a waiting time of 45 s; and protocol B (named "fast" ) in which only the first 3 ml of particles were interspaced by the same waiting time of 45 s, the following being injected without any waiting time in between. The primary end point was the change in IPSS between both groups at 3 months and several secondary endpoints were also evaluated: per-procedure: room time, fluoroscopy duration, volume of particles, DAP , and post procedure: PSA at day 1, Change in QoL, change in prostatic volume at 1 months (MR).
Results: Mean IPSS changed from 19.4 ±6.5 (SD) [6-32] to 8.4±5.5 [2-26] in patients undergoing protocol A and from 20.5±6.5 (SD) [7-33] to 9.8 ±7.4 [1-27]in patients undergoing protocol B (p=0.84 ). However IPSS value showed a statistical significant decrease either in protocol A (p<0.0001) either in protocol B (p<0.0001). Secondary endpoints are listed as follows: Volume of particles: 18.0 ± 5.8ml (SD) [8-36] in patients undergoing protocol A and 17.0 ± 5.9ml (SD) [9-35] in patients undergoing protocol B (p=0.22) Mean PV changed from 98.1 ±39.2 ml (SD) [45-200] to 77.4±36.3 ml [30-170] in patients undergoing protocol A and from 101.4 ±59.2 ml (SD) [50-390] to 78.3 ±29.4 ml[34-160]in patients undergoing protocol B (p= 0.19 )
Conclusions: Both protocols allow to achieve significant clinical improvement, therefore, there is no need to wait between each vials after the initial 3 ml have been injected.