Venn 1995.

Study characteristics
Methods	Study design: prospective, randomized study. Study dates: not reported Setting: outpatient, multicenter center, national Country: United Kingdom
Participants	Inclusion criteria: men with: Madsen score > 8 Urodynamic evidence of BOO Residual urine volumes < 250 mL Predominantly lateral lobe enlargement No evidence of prostate or bladder cancer No previous surgery on the lower urinary tract Exclusion criteria: not reported Total number of participantsrandomized: 96 Group 1: n = 48 Transurethral microwave hyperthermia Age (years) 70.5 Madsen score 12.7 AUA score 19.2 AUA bothersome score 11 Urinary flow rate (mL/s) 11.5 Prostatic volume (cm3) 40.4 * no SD or 95% CI reported Group 2: n = 48 transurethral sham Age (years) 68 Madsen score 13 AUA score 20.1 AUA bothersome score 12.3 Urinary flow rate (mL/s) 10.2 Prostatic volume (cm3) 40.6 * no SD or 95% CI reported
Interventions	Group 1 (n = 48) TUMT Patients in the treated group underwent 1 h of microwave hyperthermia, with a maximum urethral temperature of 46 °C or a maximum rectal temperature of 42.5 °C. The machine was designed and constructed in conjunction with Microwave Engineering Designs, Newport, Isle of Wight, UK (434MHz, maximum power of 50 W). The antenna was a helical coil, loaded in a modified eyeless 22F Foley Simplastic catheter fitted with water cooling. Group 2 (n = 48) Sham Treated with the same procedure but without the use of heat. Co‐interventions: After selection for inclusion in the trial a treatment catheter was inserted under antibiotic cover (gentamicin 80 mg).
Outcomes	Urologic symptom scores How measured: Madsen score. AUA score and AUA bothersome score. Time points measured: baseline, 3 and 6 months Time points reported: baseline, 3 and 6 months Subgroups: none Relevant outcomes not reported in this study Quality of life Retreatment Ejaculatory function Erectile function Major and minor adverse events Acute urinary retention Indwelling urinary catheter
Funding sources	Not available
Declarations of interest	Not available
Notes	Patients were selected from waiting lists for transurethral resection of the prostate (TURP) at St Thomas's Hospital and Worthing Hospital, or by direct referral. Cross‐over: after 3 months, 47 patients in the treated group and 46 of the controls were assessed. After 6 months, 42 treated patients and 20 control patients were assessed, because 24 patients in the control group had been made aware of the sham treatment and so were not included in the analysis. Protocol: not available. Language of publication: English.
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: “patients were then randomly assigned to either a treated or control group by selection of sealed envelopes prepared before the trial.”
Allocation concealment (selection bias)	Unclear risk	Participants and investigators enrolling participants could not foresee assignment, although it is not clear if the envelopes were opaque. Quote: “patients were then randomly assigned to either a treated or control group by selection of sealed envelopes prepared before the trial.”
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	It is unclear if personnel was blinded (first three months). Quote: “The patients were not aware of the group to which they were assigned.”
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	These outcomes are likely to be affected by blinding. Quote: “The patients were not aware of the group to which they were assigned.”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	These outcomes are unlikely to be affected by blinding. Quote: “The patients were not aware of the group to which they were assigned.”
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	Low risk	All outcomes: outcome data was available for nearly all participants. After 3 months, 47/48 patients in the treated group and 46/48 of the controls were assessed (6 month data not included in this review, see “notes”).
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 identified.