Pisco 2020.

Study characteristics
Methods	Study design: parallel randomized controlled study Setting/country: single center/Portugal Dates when study was conducted: September 2014 to March 2018
Participants	Inclusion criteria: men aged > 45 years; diagnosis of LUTS/BPH based on clinical history, digital rectal exam, urinalysis, TRUS, and PSA; severe LUTS defined, at screening and at a baseline visit 2 weeks apart, by IPSS of 20 and QoL score of 3 after a minimum of 6 months' treatment with alpha‐blockers for LUTS/BPH; Qmax < 12 mL/second; prostate volume 40 mL Exclusion criteria: men with computed tomography angiography showing that prostatic arteries were not feasible for PAE; previous surgical or invasive prostate treatments such as TURP, transurethral microwave therapy, transurethral needle ablation, laser, or any other minimally invasive treatment; acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain, or abnormal sensation in the penis, testis, or anal or pelvic area in the previous 12 months; history of prostate or bladder cancer or pelvic irradiation; active or recurrent urinary tract infections (more than 1 episode in the previous 12 months); history of neurogenic bladder or LUTS secondary to neurologic disease; advanced atherosclerosis and tortuosity of iliac and prostatic arteries; secondary renal insufficiency (due to prostatic obstruction); large bladder diverticula or stones; detrusor failure; history of acute urinary retention; current severe, significant, or uncontrolled disease; bleeding disorder such as hemophilia, clotting factor deficiency, anticoagulation, or bleeding diathesis; hypersensitivity or contraindication to tamsulosin use; mental condition or disorder that would interfere with the man's ability to provide informed consent; participation in a study of any investigational drug or device in the previous 3 months; and administration of the 5‐alpha reductase inhibitors finasteride in the previous 6 months and dutasteride in the previous 3 months. The latter criterion was changed by a protocol amendment to administration of the 5‐alpha reductase inhibitors finasteride in the previous 2 weeks and dutasteride in the previous 4 months (these men may be included if they stop those medications and replace them for tamsulosin, alfuzosin, or silodosin for ≥ 2 weeks for finasteride and ≥ 4 months for dutasteride) Total number of participants randomly assigned: 80 Group A (PAE) Number of all participants randomly assigned: 40 Age (years): median 64 (IQR 59 to 67.5) Prostate volume (mL): median 63.5 (IQR 55.5 to 100) PSA (ng/mL): median 3.04 (IQR 1.54 to 5.15) IPSS: median 25.5 (IQR 22.5 to 29) Qmax (mL/second): median 7.9 (IQR 5.55 to 10.2) Group B (sham) Number of all participants randomly assigned: 40 Age (years): median 64 (IQR 60 to 68.5) Prostate volume (mL): median 66 (IQR 55.5 to 94.5) PSA (ng/mL): median 3.10 (IQR 1.59 to 3.71) IPSS: median 27.5 (IQR 24 to 30.5) Qmax (mL/second): median 7.30 (IQR 4.90 to 9.40)
Interventions	Group A: PAE Group B: sham (after catheterization of 1 prostatic artery, the catheter was removed and no particles were injected) Follow‐up: 6 months
Outcomes	Primary outcome IPSS and QoL How measured: IPSS questionnaires Time points measured: at baseline, 1 month, 3 months, and 6 months Time points reported: at baseline, 1 month, 3 months, and 6 months Secondary outcomes BPH Impact Index/IIEF‐15/prostate volume/Qmax/PVR/PSA How measured: BPH Impact Index/IIEF‐15/TRUS/not reported/not reported/not reported Time points measured: at baseline, 1 month, 3 months, and 6 months Time points reported: at baseline, 1 month, 3 months, and 6 months Procedure variable: fluoroscopy times/radiation dose/pain How measured: not reported/not reported/visual analog scale Time points measured: during procedure, at discharge, and the next morning Time points reported: during procedure, at discharge, and the next morning Safety outcomes: adverse events How measured: Clavien‐Dindo Classification Time points measured: at baseline, 1 month, 3 months, and 6 months Time points reported: likely cumulative incidence Subgroup: none
Funding sources	Partially funded by an unrestricted grant from BTG plc (London, UK)
Declarations of interest	None
Notes	Protocol: NCT02074644 Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a randomisation list consisting of permuted blocks of size varying between 4 and 8 was prepared by the trial biostatistician".
Allocation concealment (selection bias)	Low risk	Quote: "the allocation sequence was concealed using opaque envelopes numbered sequentially".
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "patients were blinded to the intervention received until end of single‐blind period". Judgment: single‐blind study (participants).
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Judgment: single‐blind study (participants).
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	Low risk	Judgment: all randomized participants 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 (short term).
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgment: no information given (not reported): author reply – all randomized participants were included in the analysis (short term).
Incomplete outcome data (attrition bias) Erectile function	Low risk	Judgment: all randomized participants were included in the analysis (short term).
Incomplete outcome data (attrition bias) Ejaculatory disorders	Low risk	Judgment: all randomized participants were included in the analysis (short term).
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgment: all randomized participants were included in the analysis (short term).
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: no information given (not measured).
Selective reporting (reporting bias)	Low risk	Judgment: protocol was published and study outcomes were well predefined and described.
Other bias	Low risk	Judgment: tamsulosin was prescribed longer for the sham group. However, it made the difference between groups much smaller (more conservative).