Brehmer 1999.

Study characteristics
Methods	Study design: prospective, randomized parallel study Study dates: study dates not available Setting: outpatient, single‐center, national Country: Sweden
Participants	Inclusion criteria: men with low urinary tract symptoms dominated by: Hesitancy Slow urination Enlarged prostate Maximum flow‐rate (Q ) of < 12 mL/s Exclusion criteria: men with: Indwelling catheter Median prostatic lobe Prostate gland estimated as > 50 g Suspected prostatic malignancy Neurological disease Previous surgery for prostatic disease Total number of participants randomized: 44 Age, mean (range): 70.4 (53 – 83) years. (No disaggregated data by group reported) Group 1: n = 16 60‐min TUMT ICS questionnaire A: 49 (of a maximum of 124) (see notes) ICS questionnaire B: 36 (of a maximum of 92) (see notes) Qmax: 7mL/s Group 2: n = 14 30‐min TUMT ICS questionnaire A: 58 (of a maximum of 124) (see notes) ICS questionnaire B: 40 (of a maximum of 92) (see notes) Qmax: 8.7 mL/s Group 3: n = 14 Sham ICS questionnaire A: 46 (of a maximum of 124) (see notes) ICS questionnaire B: 36 (of a maximum of 92) (see notes) Qmax: 7.9 mL/s
Interventions	Group 1 (n = 16): 60‐min TUMT ECP system (Comair, Sweden) equipped with a microwave antenna (915 MHz), a fibreoptic system for measuring the temperature in the urethra and, by a rectal probe, in the rectum. It contained a circulating cooling system that reduced the heat delivered to the urethral wall with a maximum heating at 30 s and a temperature limit of 46 °C in the urethra and of 43 °C in the rectum. After treatment, a voiding trial was attempted; if difficulties arose, a urethral catheter was inserted and left in place for three days. Group 2 (n = 14): Similar intervention as group 1, except that the duration of the session was 30 min. Group 3 (n = 14): Sham “Only water at 20 °C was circulated in the treatment catheter and a computer monitor, visible to the patient, showed a simulated heat‐treatment curve, similar to that produced during TUMT.” Co‐interventions: Antibiotics (norfloxacin).
Outcomes	Minor and major adverse event How measured: number of participants suffering a bacterial cystitis despite antibiotic treatment Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: number of participants requiring other treatment within the follow‐up year Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study: Urologic symptom scores: ICS questionnaires, results were not adequately reported (as percentage of change from baseline) Quality of life Erectile function Ejaculatory function Acute urinary retention/indwelling urinary catheter (no disaggregated data by group)
Funding sources	Not available
Declarations of interest	Not available
Notes	ICS questionnaire consists of 32 questions, most of which comprise an ‘A’ question about the actual symptom and a ‘B’ question about the bother related to the symptom. The questionnaire also includes several questions about sexual function (nos 24 – 27); these were all excluded from the instrument used in the present study. The maximum A and B scores are 124 and 92, respectively; a high score indicates worse symptoms. 2 participants withdrew during the 1‐year study period, leaving 42 for the final evaluation. No contact information available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “The patients were randomised to undergo 30 or 60 min of TUMT, or to sham treatment (14, 16 and 14 men, respectively).” Comment: Insufficient information about the sequence generation process to permit judgment of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgment of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information about blinding of personnel.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	The participants were blinded: “study where the patients were unaware of the type of treatment given.” Comment: Outcomes are unlikely to be affected by lack of blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	The participants were blinded: “study where the patients were unaware of the type of treatment given.”
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgment of ‘Low risk’ or ‘High risk’.
Selective reporting (reporting bias)	Unclear risk	No protocol available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Other bias	Low risk	No other sources of bias were identified.