. 2021 Jul 15;2021(7):CD013656. doi: 10.1002/14651858.CD013656.pub2

Gratzke 2017.

*Study characteristics*
Methods	Study design: prospective, randomized, controlled, non‐blinded study Dates when study was conducted: February 2012 to October 2013 Setting: multicentre / international / outpatient/inpatient / 10 centres in Europe Countries: Denmark, the UK, Germany
Participants	Inclusion criteria: men aged ≥ 50 years with IPSS > 12, Q_max ≤ 15 mL/second for 125 mL voided volume, postvoid residual volume < 350 mL, prostate volume ≤ 60 mL on ultrasound, sexually active within 6 months before the index procedure, Sexual Health Inventory for Men score > 6, positive response to MSHQ‐EjD (excluding the response “Could not ejaculate”), Incontinence Severity Index score ≤ 4 Exclusion criteria: active urinary tract infection at time of treatment, bacterial prostatitis within 1 year of the index procedure, cystolithiasis within 3 months of the index procedure, obstructive median lobe as assessed via ultrasound and cystoscopy, current urinary retention, urethral conditions that may prevent insertion of a rigid 20 F cystoscope, previous TURP or laser procedure, pelvic surgery or irradiation, PSA ≥ 10 ng/L, history of prostate or bladder cancer, severe cardiac comorbidities, anticoagulants within 3 days of the index procedure (excluding up to 100 mg aspirin (acetylsalicylic acid), other medical condition or comorbidity contraindicative for TURP or PUL, unwilling to report sexual function Total number of participants randomly assigned: 91 Group A (PUL) Number of all participants randomly assigned: 45 Age (mean ± SD): 63 ± 6.8 years Prostate volume (mean ± SD): 38 ± 12 mL PSA (mean ± SD): 2.4 ± 1.8 ng/mL IPSS (mean ± SD): 22 ± 5.7 Q_max (mean ± SD): 9.2 ± 3.5 mL/second Group B (TURP) Number of all participants randomly assigned: 46 Age (mean ± SD): 65 ± 6.4 years Prostate volume (mean ± SD): 41 ± 13 mL PSA (mean ± SD): 2.6 ± 2.1 ng/mL IPSS (mean ± SD): 23 ± 5.9 Q_max (mean ± SD): 9.5 ± 3.2 mL/s
Interventions	Group A: PUL PUL involved transurethral placement of small, permanent UroLift implants to retract the lateral lobes of the prostate and reduce obstruction. Typically, multiple implants are placed to deobstruct the prostatic urethra. Surgeons' experiences with PUL varied from 0 to 20 procedures before enrollment. Group B: TURP Licensed urologists trained and experienced in TURP conducted procedures in accordance with their own normal standards and practices. Follow‐up: 24 months
Outcomes	Urologic symptoms score How measured: IPSS score Time points measured: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Time points reported: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Subgroups: none Quality of life How measured: IPSS QoL, SF‐12, Derivative single‐index SF‐6D utility score Time points measured: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Time points reported: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Subgroups: none Minor and major adverse events (including indwelling urinary catheter and acute urinary retention) How measured: Clavien‐Dindo classification of adverse events Time points measured: not reported Time points reported: at 1 year Subgroups: none Erectile function and ejaculatory function How measured: Sexual Health Inventory for Men, MSHQ‐EjD Time points measured: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Time points reported: at baseline, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years Subgroups: none Retreatment How measured: secondary treatment Time points measured: not reported Time points reported: at 2 years Subgroups: none
Funding sources	Drs Speakman, Berges, Sievert, and Sønksen reported grants from NeoTract, Inc.
Declarations of interest	Dr Gratzke reported honoraria from Astellas, Lilly, Janssen, and Amgen. Dr Barber reported support from NeoTract, Inc., Olympus, Boston Scientific, and Intuitive Surgical for proctoring and lecturing. Dr Chapple reported personal fees and non‐financial support from Allergan, grants, personal fees and non‐financial support from Astellas, personal fees and non‐financial support from Boston, personal fees and non‐financial support from Medtronic, personal fees from Pfizer, personal fees and non‐financial support from Recordati, and grants from NeoTract, Inc. during the conduct of the study. Dr Sonksen reported support from NeoTract, Inc. for proctoring and lecturing.
Notes	Protocol: NCT01533038 Language of publication: English
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Parallel 1:1 randomisation was performed using permuted blocks of random sizes, stratified by study site.”
Allocation concealment (selection bias)	Low risk	Quote: “concealed through a password‐protected computer system,” “random sequence revealed at the time of the procedure.”
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Judgement: non‐blinded study.
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Judgement: non‐blinded study.
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) Urologic symptom scores/Quality of life	Unclear risk	Judgement: 40/45 (88.8%) of randomized participants in PUL and 32/35 (91.4%) in TURP groups were included in analysis (short term)/ 37/45 (82.2%) of randomized participants in PUL and 32/35 (91.4%) in TURP groups were included in analysis (long term).
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Judgement: all participants who were randomized were included in analyses.
Incomplete outcome data (attrition bias) Retreatment	Low risk	Judgement: 44/45 (97.7%) of randomized participants in PUL and 35/35 (100%) in TURP groups were included in analysis.
Incomplete outcome data (attrition bias) Erectile function	High risk	Judgement: Short term: 32/45 (71.1%) of randomized participants in PUL and 27/35 (77.1%) in TURP were included in analysis. Long term: 29/45 (64.4%) of randomized participants in PUL and 28/35 (80.0%) in TURP were included in analysis.
Incomplete outcome data (attrition bias) Ejaculatory function	High risk	Judgement: Short term: 32/45 (71.1%) of randomized participants in PUL and 27/35 (77.1%) in TURP were included in analysis. Long term: 29/45 (64.4%) of randomized participants in PUL and 27/35 (77.1%) in TURP were included in analysis.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	Judgement: 44/45 (97.7%) of randomized participants in PUL and 35/35 (100%) in TURP were included in analysis.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Judgement: not described in the study or protocol (not adequately described).
Selective reporting (reporting bias)	Low risk	Judgement: review outcomes were prespecified in the protocol (NCT01533038) and were analyzed as planned.
Other bias	Low risk	Judgement: not detected.