McVary 2016.

Study characteristics
Methods	Study design: prospective, multicentre, double‐blinded study Study dates: September 2013 to August 2014 Setting: multicenter (15) / outpatient / national Country: USA
Participants	Inclusion criteria Males at least 50 years of age who had symptomatic BPH IPSS 13 or greater Qmax between 5 and 15 mL per second with a minimum voided volume 125 mL or greater Prostate volume 30 gm to 80 gm measured by transrectal ultrasound No prior invasive prostate intervention or surgery of the prostate Provided informed consent Required to undergo a washout period for the following: antihistamines (1 week); a‐blockers, anticholinergics, or daily dose phosphodiesterase type 5 inhibitors (4 weeks); oestrogen, androgen suppressing drugs, anabolic steroid, or type II 5a‐reductase inhibitors (3 months); dual 5a‐reductase inhibitors (6 months) Exclusion criteria PVR greater than 250 mL PSA greater than 2.5 ng/mL with a free PSA less than 25% (unless prostate cancer was ruled out by biopsy) An active urinary tract infection within 7 days, or 2 independent infections within the last 6 months Total number of menrandomized: 197 Group A (convective radiofrequency water vapor thermal therapy) Number of men randomized: 136 Age in years (mean ± SD): 63 ± 7.1 Prostate volume in mL (mean ± SD): 45.8 ± 13.0 PSA in ng/mL (mean ± SD): 2.1 ± 1.5 IPSS (mean ± SD): 22 ± 4.8 Qmax in mL/s (mean ± SD): 9.9 ± 2.3 PVR in mL (mean ± SD): 82 ± 51.5 OP time: NR Group B (sham) Number of men randomized: 61 Age in years (mean ± SD): 62.9 ± 7.0 Prostate volume in mL (mean ± SD): 44.5 ± 13.3 PSA in ng/mL (mean ± SD): 2.0 ± 1.6 IPSS (mean ± SD): 21.9 ± 4.7 Qmax in mL/s (mean ± SD): 10.4 ± 2.1 PVR in mL (mean ± SD): 82 ± 51.5 OP time: NR
Interventions	Group A: Rezūm Thermal treatment procedure was performed using the Rezūm system, including a generator containing an RF power supply, system controls and a single‐use transurethral delivery device that incorporates a standard 4 mm, 30 degree cytoscopy lens.   Group B:Sham procedure Insertion of a rigid cystoscope and the Rezūm System generator. The device was activated by the investigator’s staff to generate similar sensations to the participant's body.
Outcomes	Urologic symptom scores How measured: IPSS score Time points measured: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Time points reported: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Subgroups: IPSS severity Quality of life How measured: IPSS‐QoL / BPH Impact Index II Time points measured: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Time points reported: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Subgroups: IPSS severity Erectile function How measured: IIEF‐15 Time points measured: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Time points reported: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Subgroups: IPSS severity Ejaculatory function How measured: MSHQ‐EjD Time points measured: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Time points reported: before the procedure and at follow‐up visits (at 2 weeks, and 1, 3, 6, 12, 24, 36 months) Subgroups: IPSS severity Retreatment How measured: participants with a surgical procedure at follow‐up Time of measurement: NR but likely for follow‐up period Time of reporting: likely cumulative incidence Major and minor adverse events (including acute urinary retention and indwelling catheter) How measured: adjudicated by independent evaluation committee Time of measurement: NR but likely for follow‐up period Time of reporting: likely cumulative incidence
Funding sources	NxThera Inc., Maple Grove, Minnesota
Declarations of interest	Several co‐authors had direct financial interest or relationships described as 'other' with NeoTract and NxThera as the device manufacturer.
Notes	The study was unblinded at three months and patients crossed‐over (we did not include data after unblinding). Protocol:ClinicalTrial.gov (NCT01912339) Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “randomized with an electronic program before treatment using permuted blocks of random sizes, stratified by investigational site”. Judgement: appropriate method of sequence generation.
Allocation concealment (selection bias)	Low risk	Quote: “randomized with an electronic program before treatment using permuted blocks of random sizes, stratified by investigational site”. Judgement: not explicitly described, but likely central randomization with allocation concealment.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: “Study participants and study personnel administering questionnaires were double‐blinded until the 3‐month follow‐up... The treating physician was not blinded in order to perform the treatments but did not participate in the follow‐up or the administration of outcomes questionnaires.” Judgement: personnel were not blinded (surgeon: could not feasibly be).
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: “Study participants and study personnel administering questionnaires were double‐blinded until the 3‐month follow‐up... An independent data monitoring committee reviewed safety. All AEs reviewed were adjudicated by an independent clinical evaluation committee.” Judgement: the outcomes grouped here are either self‐assessed by the participant or refer to adverse event assessment. For both types of outcomes, the study provides assurance of blinding.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Judgement: blinding deemed not relevant to these outcomes.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	Low risk	Judgement: almost all randomized men were included in the analyses for all reported outcomes.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Judgement: almost all randomized men were included in the analyses for all reported outcomes.
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgement: almost all randomized men were included in the analyses for all reported outcomes.
Incomplete outcome data (attrition bias) Erectile function	High risk	Quote: “At baseline, 32% (43 of 134) of the observed treatment subjects and 33% (20 of 61) of control subjects were not sexually active (reported “did not attempt intercourse”) within the past 4 weeks and were eliminated from the primary sexual function analyses.” Judgement: 90/136 (66.1%) and 40/61 (65.5%) men in experimental and control group were included in the analysis (subjects who reported no sexual intercourse were excluded from the analysis for sexual function: concern over prognostic imbalance). Comment: analyses of these outcomes were based on a non‐random subset of men.
Incomplete outcome data (attrition bias) Ejaculatory function	High risk	Quote: “At baseline, 32% (43 of 134) of the observed treatment subjects and 33% (20 of 61) of control subjects were not sexually active (reported “did not attempt intercourse”) within the past 4 weeks and were eliminated from the primary sexual function analyses.” Judgement: 90/136 (66.1%) and 40/61 (65.5%) men in experimental and control group were included in the analysis (subjects who reported no sexual intercourse were excluded from the analysis for sexual function: concern over prognostic imbalance). Comment: analyses of these outcomes were based on a non‐random subset of men.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgement: almost all randomized men were included in the analyses for all reported outcomes.
Incomplete outcome data (attrition bias) Indwelling catheter	Low risk	Judgement: almost all randomized men were included in the analyses for all reported outcomes.
Selective reporting (reporting bias)	Low risk	Judgement: all outcomes prespecified in the protocol (NCT01912339) were reported and analyzed as planned.
Other bias	Low risk	Judgement: not detected.