Insausti 2020.

Study characteristics
Methods	Study design: prospective randomized non‐inferiority clinical trial Setting/country: single center/Spain Dates when study was conducted: November 2014 and January 2017
Participants	Inclusion criteria: men aged > 60 years; BPH‐related LUTS refractory to medical treatment for ≥ 6 months, or the patient could not tolerate medical treatment; TURP was indicated; IPSS ≥ 8; QoL related to LUTS ≥ 3; Qmax ≤ 10 mL/second 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 < 30 mL/minute, 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 (SD 6.2) Prostate volume (mL): 60.0 (SD 21.6) PSA (ng/mL): 3.5 (SD 2.8) IPSS: 25.8 (SD 4.64) Qmax (mL/second): 7.7 (SD 2.0) Group B (TURP) Number of all participants randomly assigned: 30 Age (years): 71.8 (SD 5.5) Prostate volume (mL): 62.8 (SD 23.8) PSA (ng/mL): 4.4 (SD 8.7) IPSS: 26.0 (SD 7.29) Qmax (mL/second): 7.0 (SD 2.5)
Interventions	Group A: PAE Group B: bipolar TURP Follow‐up: 12 months
Outcomes	Primary outcomes Qmax/IPSS How measured: uroflowmetry/IPSS questionnaire Time points measured: at baseline, 3 months, 6 months, and 12 months Time points reported: at baseline, 3 months, 6 months, and 12 months Secondary outcomes QoL/prostate volume/PVR/IIEF‐5 How measured: IPSS questionnaire/transabdominal US/transabdominal US/IIEF‐5 questionnaire Time points measured: at baseline, 3 months, 6 months, and 12 months Time points reported: at baseline, 3 months, 6 months, and 12 months PSA How measured: blood test Time points measured: at baseline, 3 months, and 12 months Time points reported: at baseline, 3 months, and 12 months Safety outcomes: adverse events How measured: modified Clavien Classification System Time points measured: at all follow‐up visits Time points reported: likely cumulative incidence Subgroup: none
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". Judgment: the method was not described.
Blinding of participants and personnel (performance bias) All 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	Judgment: objective outcomes likely not affected by lack of blinding.
Incomplete outcome data (attrition bias) Urologic symptom scores/QoL	High risk	Judgment: 23/31 (74.1%) participants randomized to PAE and 22/30 (73.3%) to TURP were included in the analysis (short term).
Incomplete outcome data (attrition bias) Major/minor adverse events	Low risk	Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Erectile function	Low risk	Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Ejaculatory disorders	Low risk	Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias) Indwelling urinary catheter	Unclear risk	Judgment: no information given (not measured).
Incomplete outcome data (attrition bias) Hospital stay	Unclear risk	Judgment: 27/31 (87.0%) participants randomized to PAE and 27/30 (90.0%) to TURP were included in the analysis (short term).
Selective reporting (reporting bias)	High risk	Judgment: protocol was published, but study outcomes were not identical to the outcomes prespecified in the protocol.
Other bias	Low risk	Judgment: BPH medication was prescribed longer for the PAE group; however, it seemed this did not affect results 12 months after treatment.