Nawrocki 1997.

Study characteristics
Methods	Study design: prospective, randomized parallel study. Study dates: not reported Setting: outpatient, single center, national Country: United Kingdom
Participants	Inclusion criteria: men with symptoms of lower urinary tract dysfunction due to benign enlargement of the prostate meriting surgical treatment Qmax < 15 mL/s and voided volume ≥ 150 mL and a maximum detrusor pressure ≥ 70 cm H2O. Exclusion criteria: men with: Complications of bladder outlet obstruction Urinary retention Residual urine volume > 350 mL Renal failure Recurrent urinary tract infection Bladder calculus Bladder diverticulum Suspicion of malignancy Clinical features suggestive of malignancy DRE suspicious of malignancy Abnormal PSA level Short prostate (< 30 mm on TRUS) Presence of a prominent middle lobe projecting asymmetrically into the bladder Presence of a urethral stricture Previous prostate or pelvic surgery or radiotherapy Presence of metal within the lower trunk or upper legs Uncontrolled cardiac dysrhythmias or presence of a cardiac pacemaker Presence of neurological disorders that might affect the lower body Inability to understand the investigations, treatment procedure or give fully informed consent Presence of other treatment/medication which might affect lower urinary tract function Total number of participants randomized: 120 Age, median (range): 70 (56‐80) years (no disaggregated data by group available) Group 1: n = 38 transurethral microwave thermotherapy (TUMT) AUA score, median(range): 19 (7‐31) Qmax, mean (SD): 8.83 (2.32) mL/s Prostate volume, mean (SD): 41.2 (14.6) mL Group 2: n = 40 sham transurethral microwave thermotherapy (TUMT) AUA score, median(range): 17.5 (7‐28) Qmax, mean (SD): 9.44 (2.78) mL/s Prostate volume, mean (SD): 46.7 (16.8) mL Group 3: n = 42 no treatment AUA score, median(range): 18 (10‐29) Qmax, mean (SD): 8.79 (2.66) mL/s Prostate volume, mean (SD): 46.4 (19.9) mL
Interventions	Group 1 (n = 38): TUMT was delivered for an hour under local anaesthesia, through a urethral catheter. The temperature was measured through the catheter and a rectal probe and guided the cooling of the urethra through a software (Prostasoft v2.0) which was not under the control of the operator. Group 2 (n = 40): A technically identical procedure to standard TUMT with no microwaves, with similar noise and appearance with simulated heat using a heat pad. Group 3 (n = 42): No treatment (they received treatment after completion of the study). Co‐interventions: not reported
Outcomes	Urologic symptom scores How measured: AUA score Time points measured: baseline and 6 months Time points reported: baseline and 6 months Subgroups: none Major and minor adverse events How measured: not reported Time points measured: not reported Time points reported: not reported Subgroups: none Acute urinary retention How measured: number of patients developing acute urinary retention in the first 24hs after treatment. Time points measured: not reported Time points reported: not reported Subgroups: none Indwelling urinary catheter How measured: number of patients developing acute urinary retention in the first 24hs after treatment which required catheterization for up to one week. Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study Quality of life Retreatment Erectile function Ejaculatory function
Funding sources	LORS grant from the South East Thames Regional Research Committee.
Declarations of interest	Not available
Notes	We included that TUMT and sham arm of these studies in our review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The investigators describe a random component in the sequence generation process. Quote: “Randomization was carried out by selecting one of three differently numbered but otherwise identical balls from a sealed bag.”
Allocation concealment (selection bias)	High risk	The allocation could be tampered considering that the balls could be re‐inserted to the bag and pulled out again. Quote: “Randomization was carried out by selecting one of three differently numbered but otherwise identical balls from a sealed bag.”
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. Quote: “The treatment of the standard and simulated TUMT groups was designed and carried out as a double‐blind, so that neither the operator nor the patient was aware of which treatment was being per‐ formed. Patients randomized to group 3 were treated after completion of the study”
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	Low risk	No apparent missing outcome data.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	No apparent missing outcome data.
Incomplete outcome data (attrition bias) Acute urinary retention	Low risk	No apparent missing outcome data.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Not fully measured (narrative statement).
Selective reporting (reporting bias)	Unclear risk	No protocol available. There is a trial registry (ISRCTN24866285), however it was retrospectively registered and there is no information regarding the outcomes.
Other bias	Low risk	No other sources of bias were identified.