Roehrborn 2013.

Methods	Study design: multicentre randomized blinded trial Setting/country: 19 centres in US 14, Canada 2, Australia 3 Dates when study was conducted: February to December 2011
Participants	Inclusion criteria: men aged ≥ 50 years, provided informed consent, had no prior surgical treatment for BPH, and were required to undergo washouts of 2 weeks for alpha‐blocker, 3 months for 5a‐reductase inhibitor, and 3 days for anticoagulants. Admission to the study required ≥ IPSS 13, Qmax ≤ 12 mL/second with a 125 mL voided volume and a 30‐ to 80‐mL prostate volume Exclusion criteria: median lobe obstruction, retention, postvoid residual volume > 250 mL, active infection, PSA > 10 ng/mL (unless negative biopsy), cystolithiasis within 3 months, and bacterial prostatitis within 1 year Total number of participants randomly assigned: 206 Group A (PUL) Number of all participants randomly assigned: 140 Age (mean ± SD): 67 ± 8.6 years Prostate volume (mean ± SD): 44.5 ± 12.4 mL PSA (mean ± SD): 2.4 ± 2.0 ng/mL IPSS (mean ± SD): 22.2 ± 5.48 Qmax (mean ± SD): 8.9 ± 2.2 mL/second Group B (Sham) Number of all participants randomly assigned: 66 Age (mean ± SD): 65 ± 8.0 years Prostate volume (mean ± SD): 40.9 ± 10.8 mL PSA (mean ± SD): 2.1 ± 1.6 ng/mL IPSS: 24.4 ± 5.75 Qmax (mean ± SD): 8.8 ± 2.2 mL/second
Interventions	Group A: PUL Transprostatic adjustable UroLift implants are permanently implanted to retract obstructing lateral lobes and expand the urethral lumen. After rigid cystoscopy is performed, the implant delivery device is inserted into the 20‐F sheath. Under cystoscopic visualization using a 2.9 mm 0‐degree lens, the delivery device is angled anterolaterally to compress the obstructive lobe. A 19‐gauge needle, housing a monofilament with metallic tab, is then deployed through the prostate lobe. As the needle is retracted, the tab engages the prostate capsule and the monofilament is tensioned. Finally, the urethral end‐piece is attached to the monofilament, which is then cut, delivering the in situ‐sized implant. Group B: sham Conducted with as similar an experience as possible to PUL. Follow‐up: 3 months
Outcomes	Primary outcome Reduction in IPSS at 3 months after the PUL procedure was ≥ 25% greater than that of sham How measured: IPSS questionnaires Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Secondary outcome QoL (IPSS‐QoL) BPH Impact Index International Index of Erectile Function MSHQ‐EjD How measured: questionnaires Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Safety outcomes How measured: adverse events Time points measured: not reported Time points reported: at 3 months Subgroup: none
Funding sources	NeoTract, Fe/Male Health Centre
Declarations of interest	NeoTract, Fe/Male Health Centre
Notes	Protocol: NCT01294150 Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was conducted just before treatment using permuted blocks of various sizes chosen at random through a central electronic data program."
Allocation concealment (selection bias)	Low risk	Quote: "concealed through password protected electronic database program."
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Judgement: we contacted with author and they clarified the blinding of participants and outcome assessor. The personnel were not blinded.
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "An independent data monitoring committee assessed safety, and all AEs were adjudicated and assessed by an independent clinical events committee… A double‐blind was maintained through the 3‐month end point with the patient and questionnaire administrator blinded to randomization. Blinding of participants was tested upon discharge and at each follow‐up to 3 months."
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Judgement: objective outcomes were not likely affected by lack of blinding.
Incomplete outcome data (attrition bias) Urological symptom scores/QoL	Low risk	Judgement: all participants who were randomized were included in analysis.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Judgement: all participants who were randomized were included in analysis.
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgement: all participants who were randomized were included in analysis.
Incomplete outcome data (attrition bias) Erectile function	Low risk	Judgement: 132/140 (94.2%) of randomized participants in PUL and 65/66 (98.4%) in sham groups were included in the analysis.
Incomplete outcome data (attrition bias) Ejaculatory function	High risk	Judgement: 94/140 (67.1%) of randomized participants in PUL and 50/66 (75.7%) in sham groups were included in analysis.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgement: all participants who were randomized were included in analysis.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Judgement: not described in the study or protocol.
Incomplete outcome data (attrition bias) Hospital stay	Low risk	Judgement: 137/140 (97.8%) of randomized participants in PUL and 64/66 (96.9%) in sham groups were included in analysis.
Selective reporting (reporting bias)	Low risk	Judgement: review outcomes were prespecified in the protocol (NCT01294150) and were analyzed as planned.
Other bias	Low risk	Judgement: not detected.

BPH: benign prostatic hyperplasia; IPSS: International Prostate Symptom Score; MSHQ‐EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; PGI‐I: Patient Global Impression of Improvement; PSA: prostate‐specific antigen; PUL: prostatic urethral lift; Q_max: maximum flow rate; QoL: quality of life; SD: standard deviation; SF‐6D: Short‐Form Six‐Dimension; SF‐12: 12‐item Short‐Form Health Survey; TURP: transurethral resection of prostate.