Abt 2018.

Study characteristics
Methods	Study design: open label, randomized controlled trial (non‐inferiority trial) Study dates: February 2014 to May 2017 Setting: single centre, national, outpatient/inpatient Country: Sweden
Participants	Inclusion criteria: men aged at least 40 years, TURP indicated, refractory to medical treatment or not willing to undergo or continue medical treatment, with a prostate size 25‐80 mL as measured by transabdominal ultrasound, with an IPSS of at least 8, with an IPSS related QoL of at least 3 points, with a maximum urinary flow rate of less than 12 mL/s or urinary retention, and who provided written informed consent. Exclusion criteria: men with severe atherosclerosis, aneurysmatic changes or severe tortuosity in the aortic bifurcation or internal iliac arteries, a contractile detrusor, neurogenic lower urinary tract dysfunction, urethral stenosis, bladder diverticulum, bladder stone, allergy to intravenous contrast media, contraindication for magnetic resonance imaging, pre‐interventionally proven carcinoma of the prostate, and renal failure (glomerular filtration rate < 60 mL/min). Total number of participants randomly assigned: 103 Group A(PAE) Number of all participants randomly assigned: 51 Age (years): 65.7 ± 9.3 Prostate volume (mL): 52.8 ± 32.0 PSA (ng/mL): 4.2 ± 5.4 IPSS: 19.38 ± 6.37 Qmax (mL/s): 7.47 ± 4.14 Group B(TURP) Number of all participants randomly assigned: 52 Age (years): 66.1 ± 9.8 Prostate volume (mL): 56.5 ± 31.1 PSA (ng/mL): 4.5 ± 5.6 IPSS: 17.59 ± 6.17 Qmax (mL/s): 7.25 ± 4.46
Interventions	Group A: PAE Group B: monopolar TURP Follow‐up: 12 weeks
Outcomes	Urologic symptom scores How measured: IPSS Time points measured: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Time points reported: at the baseline, 1, 6, and 12 weeks, 12 and 24 months. Subgroups: none Quality of life How measured: IPSS QOL Time points measured: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Time points reported: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Subgroups: none Erectile function How measured: IPSS QOL Time points measured: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Time points reported: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Subgroups: none Ejaculatory disorder/Acute urinary retention/Indwelling urinary catheter How measured: Narratively Time points measured: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Time points reported: likely cumulative incidence Subgroups: none Retreatment How measured: Number of participants receiving TURP Time points measured: not specified Time points reported: at 24 months Subgroups: none Major/Minor adverse events How measured: How measured: modified Clavien system and common terminology criteria for adverse events. Time points measured: at the baseline, 1, 6, and 12 weeks, 6, 12, and 24 months. Time points reported: likely cumulative incidence Subgroups: none
Funding sources	Grant from the research committee of St Gallen Cantonal Hospital
Declarations of interest	None
Notes	Protocol: NCT02054013 Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “using the data management software SecuTrial, stratifying for patient age (< 70 or ≥ 70 years) and prostate volume (< 50 or ≥ 50 mL) through minimization. SecuTrial was programmed by the clinical trials unit’s data manager, and automatic treatment allocation by SecuTrial was determined for individual patients without a predefined sequence after inclusion and entry of baseline characteristics by the investigators.”
Allocation concealment (selection bias)	Low risk	Quote: “using the data management software SecuTrial, stratifying for patient age (< 70 or ≥ 70 years) and prostate volume (< 50 or ≥ 50 mL) through minimization. SecuTrial was programmed by the clinical trials unit’s data manager, and automatic treatment allocation by SecuTrial was determined for individual patients without a predefined sequence after inclusion and entry of baseline characteristics by the investigators”.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: “Masking: None (Open Label)” in protocol.
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Quote: “Masking: None (Open Label)” in protocol. Judgement: subjective outcomes are likely to be affected by lack of blinding.
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	Low risk	Judgement: Short term: 48/51 (92.3%) and 47/52 (90.3%) participants randomized in PAE and TURP were included in the analysis, respectively (low risk of bias) Long term: 34/51 (66.7%) and 47/52 (90.3%) were included at 24‐month follow‐up (high risk of bias)
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Judgement: 48/51 (92.3%) and 51/52 (98.0%) participants randomized in PAE and TURP were included in the analysis, respectively (short term).
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgement: 48/51 (92.3%) and 51/52 (98.0%) participants randomized in PAE and TURP were included in the analysis, respectively (long‐term — attrition was due to retreatment).
Incomplete outcome data (attrition bias) Erectile function	Low risk	Judgement: Short term: 48/51 (92.3%) and 47/52 (90.3%) participants randomized in PAE and TURP were included in the analysis, respectively (low risk of bias). Long term: 34/51 (66.7%) and 47/52 (90.3%) were included at 24‐month follow‐up (high risk of bias).
Incomplete outcome data (attrition bias) Ejaculatory function	Low risk	Judgement: Short term: 48/51 (92.3%) and 47/52 (90.3%) participants randomized in PAE and TURP were included in the analysis, respectively (low risk of bias). Long term: 34/51 (66.7%) and 47/52 (90.3%) were included at 24‐month follow‐up (high risk of bias).
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgement: 48/51 (92.3%) and 51/52 (98.0%) participants randomized in PAE and TURP were included in the analysis, respectively (short term).
Incomplete outcome data (attrition bias) Indwelling catheter	Low risk	Judgement: 48/51 (92.3%) and 51/52 (98.0%) participants randomized in PAE and TURP were included in the analysis, respectively (short term).
Selective reporting (reporting bias)	Unclear risk	Judgement: protocol was published and author shared the data (not shown in the article). Results that were not predefined in the protocol were reported. Data from bladder diary was not described in method section while they were described in protocol.
Other bias	Low risk	Judgement: not detected.