D'Ancona 1998.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: January 1994 to August 1995 Setting: outpatient Country: Netherlands
Participants	Inclusion criteria: men 45 years old or older Clinically unequivocal benign prostate Prostatic length 25 to 50 mm – volume 30 to 100 cm3 Symptoms > 3 months Madsen symptom score 8 or greater PFR peak flow rate 15 mL per second Minimum voided volume of 100 mL Post‐void residual 350 mL or less Willingness and ability to comply with the study follow‐up Exclusion criteria: Neurogenic disorders that may affect bladder function Prostatic carcinoma Prior surgery of the prostate, Microwave sensitive implants (pacemaker or hip prothesis) Diabetic neuropathy Urinary retention requiring an indwelling catheter Renal impairment Obstructed bladder neck due to an enlarged median lobe of the prostate, Those who were on medication prescribed for treatment of the prostate or bladder Sample size: 52 patients were randomized Group 1: n = 125 transurethral microwave thermotherapy (TUMT) Age, mean (SD): 69.6 ± 8.5 Prostate volume (cc), mean (SD): 45 ± 15 IPSS score, mean (SD): 16.7 ± 5.6 Qmax (mL/s), mean (SD): 9.3 ± 3.4 Residual volume, mL (SD): 91 ± 105 Group 1: n = 125 transurethral resection of the prostate (TURP) Age, mean (SD): 69.3 ± 5.9 Prostate volume (cc), mean (SD): 43 ± 12 IPSS score, mean (SD): 18.3 ± 6.3 Qmax (mL/s), mean (SD): 10.0 ± 6.1 Residual volume, mL (SD): 58 ± 78
Interventions	Group 1 (n = 31): TUMT Delivered using Prostatron device with software version 2.5, for 60 minutes increasing thermal dose up to 70 watts. Urethral and rectal thermal sensors provided feedback to prevent harms. Preparation included 100 mg diclofenac suppository and 2 mg of midazolam intramuscularly. If necessary, further intravenous sedation was administered. All participants left with an indwelling urinary catheter. Group 2 (n = 21): TURP Performed by two experienced urologists with use of spinal anaesthesia. The surgical capsule was reached circumferentially from the bladder neck to the verumontanum using 24 Ch. Resectoscopes. Co‐interventions: not described
Outcomes	Urologic symptom scores How measured: Madsen symptom score and IPSS Time points measured: 1, 3, 6,and 12 months Time points reported: 3, 6, 12 months Subgroups: none Major and minor adverse events How measured: episodes of urinary tract infection, haematuria Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: “repeat treatment” Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study: Quality of life Erectile function Ejaculatory function Acute urinary retention Indwelling urinary catheter
Funding sources	Not available
Declarations of interest	Not available
Notes	No contact information available. Protocol: not available Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Participants were randomized.” Judgement: No information available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Quote: “Participants were randomized.” Judgement: No information available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Participants and personnel were not blinded. Outcomes are unlikely to be affected by lack of blinding.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	High risk	Outcome data was available for 44/52 participants at 1 year follow‐up, 2 were lost in the TURP group (bladder cancer and bladder neck sclerosis) and 6 in the TUMT group (1 underwent TURP, 1 died, 1 lost to follow‐up, 3 refused follow‐up). Unbalanced attrition.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	High risk	Outcome data was available for 44/52 participants at 1 year follow‐up, 2 were lost in the TURP group (bladder cancer and bladder neck sclerosis) and 6 in the TUMT group (1 underwent TURP, 1 died, 1 lost to follow‐up, 3 refused follow‐up). Unbalanced attrition.
Incomplete outcome data (attrition bias) Retreatment	High risk	Outcome data was available for 44/52 participants at 1 year follow‐up, 2 were lost in the TURP group (bladder cancer and bladder neck sclerosis) and 6 in the TUMT group (1 underwent TURP, 1 died, 1 lost to follow‐up, 3 refused follow‐up). Unbalanced attrition.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Narrative description (insufficient information).
Selective reporting (reporting bias)	Unclear risk	No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Other bias	Low risk	No other sources of bias were detected.