Insausti 2020.

Study characteristics
Methods	Study design: prospective, randomized, non‐inferiority clinical trial Dates when study was conducted: November 2014 and January 2017 Setting: single center Country: Spain
Participants	Inclusion criteria: men over 60 years; BPH‐related LUTS refractory to medical treatment for at least 6 months or the patient could not tolerate medical treatment; TURP was indicated; the IPSS was ≥ 8; QoL related to LUTS was ≥ 3; and Qmax was ≤ 10 mL/s or urinary retention. Exclusion criteria: men with advanced atherosclerosis and tortuosity of the iliac arteries, non‐visualization of the prostatic artery or other accessory arteries supplying the prostate on computed tomography angiography, urethral stenosis, detrusor failure or neurogenic bladder, glomerular filtration rate of less than 30 mL/min, and the presence of prostate cancer. Total number of participants randomly assigned: 61 Group A (PAE) Number of all participants randomly assigned: 31 Age (years): 72.4 ± 6.2 Prostate volume (mL): 60.0 ± 21.6 PSA (ng/mL): 3.5 ± 2.8 IPSS: 25.8 ± 4.64 Qmax (mL/s): 7.7 ± 2.0 Group B (TURP) Number of all participants randomly assigned: 30 Age (years): 71.8 ± 5.5 Prostate volume (mL): 62.8 ± 23.8 PSA (ng/mL): 4.4 ± 8.7 IPSS: 26.0 ± 7.29 Qmax (mL/s): 7.0 ± 2.5
Interventions	Group A: PAE Group B: bipolar TURP Follow‐up: 12 months
Outcomes	Urologic symptoms score How measured: IPSS score Time points measured: at baseline, 3, 6, and 12 months Time points reported: at baseline, 3, 6, and 12 months Subgroups: none Quality of life How measured: IPSS QoL Time points measured: at baseline, 3, 6, and 12 months Time points reported: at baseline, 3, 6, and 12 months Subgroups: none Erectile function How measured: IIEF‐5 Time points measured: at baseline, 3, 6, and 12 months Time points reported: (planned but not reported because there were few participants with sexual relationships) Subgroups: none Minor and major adverse events (including ejaculatory function and urinary retention) How measured: Clavien‐Dindo classification of adverse events Time points measured: at all follow‐up visit Time points reported: likely cumulative incidence Subgroups: none Relevant outcomes not reported in this study: Indwelling urinary catheter (narrative) Retreatment
Funding sources	Biocompatibles UK Ltd
Declarations of interest	Biocompatibles UK Ltd
Notes	Protocol: NCT01963312 Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Principal Investigator randomly selected a number from a table of random numbers."
Allocation concealment (selection bias)	Unclear risk	Quote: “the individual enrolling participants were unaware of the allocation of the next participants.” Judgement: the method was not described.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: “There was no blinding of clinicians or patients due to the nature of the trial.”
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Quote: “There was no blinding of clinicians or patients due to the nature of the trial.”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Judgement: objective outcomes are likely not affected by lack of blinding.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	High risk	Judgement: 23/31 (74.1%) and 22/30 (73.3%) participants randomized in PAE and TURP were included in the analysis, respectively (short term).
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Erectile function	Low risk	Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Ejaculatory function	Low risk	Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Judgement: no information given (not measured, narrative statement)
Selective reporting (reporting bias)	High risk	Judgement: protocol was published, but study outcomes were not identical with the outcomes pre‐specified in protocol.
Other bias	Low risk	Judgement: BPH medication was prescribed for a longer time in the PAE group, however, it may not have affected results at 12 months after treatment.