Randomized Controlled Trial Comparing Open Simple Prostatectomy or Prostate Artery Embolization in Large Prostates: Clinical and Urodynamic Assessment - PoPAE Study.

Objective: To evaluate the effects of Prostate artery embolization (PAE) and open simple prostatectomy (OP) on lower urinary tract symptoms and urodynamic parameters in subjects with prostate size >80cc³.

Methods: PoPAE study (OP or PAE) was a randomized, open-label controlled trial performed between January 2020 and May 2022. Subjects with large prostates (>80cc³), urodynamic parameters meeting obstruction criteria (Bladder Outlet Obstruction Index-BOOI>40), and good detrusor function (Bladder contractility index>100) were included. The primary and co-primary endpoints were the variation in peak flow rate on uroflowmetry (Qmax) and BOOI. The secondary endpoints were the IPSS and ultrasonographic changes.

Results: Twenty three and 25 subjects underwent PAE and OP were evaluated, respectively. At baseline, the 2 groups have shown similar clinical, radiological, laboratory, and urodynamic parameters. After 6 months, Qmax improved 8,3 ± 4.17 mL/sec in PAE and 15.1 ± 8.04 mL/sec in OP (mean difference 6.78 in favor of PE; P = .012 [CI -9.00 to -3.00]). After treatment, 88% of those men underwent OP were classified as unobstructed or equivocal (BOOi<40). On the other hand, 70% of subjects underwent PAE remained obstructed (BOOI>40) and none of them shifted to unobstructed status (BOOI<20). It was observed a similar reduction in IPSS and PVR in both groups.

Conclusion: PAE was inferior to conventional surgery for releasing BOO and improving peak urinary flow in large prostates. Nevertheless, PAE was able to improve symptoms and PVR, and might be an alternative method in selected patients.