Blute 1996.

Study characteristics
Methods	Study design: parallel‐group randomized trial Study dates: study dates not available Setting: outpatient Country: USA
Participants	Inclusion criteria: men with: Urinary symptoms (Madsen Symptom score > 8) PVR between 100 and 200 mL PFR < 10 mL/s Prostate length between 35 and 50 mm on ultrasound examination Exclusion criteria: men receiving medication for: Metallic implants Conditions suggesting neuropathic bladder Evidence of prostate cancer previous surgery (rectal or transurethral) Antiandrogen therapy Serum creatinine > 2 mg/dL Urinary retention Bladder stones Uncontrolled dysrhythmias or cardiac pacemakers Asymmetric median lobe enlargement Total number of participants randomized: 115 Group 1 (n = 78) TUMT AUA score, mean (SD): 19.9 (7.2) Age, mean (SD): 66.9 (7.8) years Prostate volume, mean (SD): 37.4 (14.2) mL Qmax, mean (SD): 1.3 (1.6) mL/s Group 2 (n = 37) sham AUA score, mean (SD): 20.8 (6.7) Age, mean (SD): 66.9 (7.1) years Prostate volume, mean (SD): 36.1 (13.4) mL Qmax, mean (SD): 7.4 (1.7) mL/s
Interventions	Group 1 (n = 78): TUMT Prostatron device is inserted by a 20F transurethral applicator (with 2 cooling channels) catheter and a rectal probe confirmed by ultrasonography. The treatment catheter emits a radiofrequency of 1296 MHz. The treatment consist of 3 stages: 1) cooling (to 27 ºC); 2) microwave emission to a threshold of 42.5 ºC rectal temperature; 3) progressive cooling. These details were provided in the report of a previous non‐randomized study (Blute 1993) Group 2 (n = 37): Sham This consisted of circulation of urethral coolant without application of microwave power while a sham treatment was displayed on the computer monitor. and the program run for 60 minutes Co‐interventions: Participants were given anti‐inflammatory agents and prophylactic antibiotics before and after (7 days) the procedure. If the participant experiences difficulties, a Foley catheter was inserted. Sedation was used at discretion (no sedation in 89% of TUMT sessions, and 100% of sham sessions)
Outcomes	Urologic symptom scores How measured: Madsen Symptom score / AUA symptom score Time points measured: baseline, 6 weeks, 3, 6 and 12 months Time points reported: baseline, 6 weeks, 3, 6 and 12 months (mostly graphically; comparative outcome data were only available at 3 months) Minor adverse events (including erectile/ejaculatory function) How measured: narratively including sexual adverse events Time points measured: at complete follow‐up (12 months) Time points reported: at complete follow‐up (12 months) Acute urinary retention/Indwelling urinary catheter How measured: narratively Time points measured: at complete follow‐up (12 months) Time points reported: at complete follow‐up (12 months) Relevant outcomes not reported in this study: Retreatment Quality of life Indwelling urinary catheter Major adverse events were not adequately described
Funding sources	Not available
Declarations of interest	Not available
Notes	Whereas the blinding lasted for 3 months, the follow‐up time was 12 months. The reporting of outcomes was not disaggregated by group (intervention versus sham, but for the entire population) for most outcomes and time points.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The patients were randomized to TUMT or sham treatment in a 2:1 ratio based on a permuted‐blocks procedure.”
Allocation concealment (selection bias)	Low risk	Quote: “Randomization assignments were distributed in sealed envelopes identified only by a unique patient number. The treating physician opened the envelope after completing all screening tests just prior to treatment.”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “To blind the evaluating physician to the patient's actual treatment, data on the treatment received (including post‐treatment PSA values) were not entered in the patient's study chart until after the 3‐month evaluation.” “Physicians and paramedical personnel behaved in the same fashion they would have during real thermotherapy sessions.” Comment: There was also “blinding verification” at 1 week after procedure: Quote: “When patients were queried about the treatment they had received, only half of the TUMT patients (51.3%; 40 of 78) guessed correctly, and in the sham‐treatment group, less than half of the patients (44.4%; 16 of 36) guessed correctly (Table 2).”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Double‐blind study ‐ see above.
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Double‐blind study ‐ see above.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: “Of the 150 patients treated 118 had Madsen symptom score data at 12 months, since 11 discontinued the study or were lost to follow up, 16 were re‐treated with the Prostatron unit, 4 received alternative therapy (3 underwent transurethral procedures, and 1 received terazosin) and 1 was missing a Madsen score at followup.” Comment: High attrition date for 'Urinary Symptoms Score' (21%). There is no specification about attrition by group.
Selective reporting (reporting bias)	High risk	No protocol available. Data were presented graphically for most time points. Comparative outcome data were only available at 3 month‐follow up for some outcomes.
Other bias	Low risk	No other sources of bias were detected.