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 participantsrandomized: 44 Age, mean (Range): 70.4 (53‐83) years. (No disaggregated data by group reported) Other baseline characteristics: Group 1: n = 16: 60 min TUMT ICS questionnaire A: 49 ICS questionnaire B: 36 Qmax: 7 mL/s Group 2: n = 14: 30 min TUMT ICS questionnaire A: 58 ICS questionnaire B: 40 Qmax: 8.7 mL/s Group 3: n = 14: Sham ICS questionnaire A: 46 ICS questionnaire B: 36 Qmax: 7.9 mL/s
Interventions	Group 1 (n = 16): 60 min TUMT ECP system (Comair, Sweden) equipped with a 22 F catheter with a microwave antenna (915 MHz), a fibre‐optic system for measuring the temperature in the urethra and, by a rectal probe, in the rectum. The two‐way urethral catheter has a circulating cooling system that reduces the heat delivered to the urethral wall. Maximum heating is achieved within 30 s and the temperature limit is 46 °C in the urethra and 43 °C in the rectum. After treatment, the patients were asked to remain in the department to attempt to void; if difficulties arose, a urethral catheter was inserted and left in place for 3 days. All the patients were given antibiotics (norfloxacin) for 5 days.” Group 2 (n = 14): Similar intervention as group 1, except that the duration of the session was 30 min. Group 3 (n = 14): “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: not reported
Outcomes	Urologic symptom scores How measured: ICS questionnaires A and B (see notes) Time points measured: baseline and 3 to 6 months Time points reported: baseline and 4 months Subgroups: none Indwelling urinary catheter How measured: number of patients requiring an indwelling catheter after treatment. Time points measured: not reported Time points reported: not reported Subgroups: none Minor and major adverse event How measured: number of patients suffering a bacterial cystitis despite antibiotic treatment. Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: number of patients 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: Quality of life Erectile dysfunction Ejaculatory dysfunction Acute urinary retention
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. Two patients withdrew during the 1‐year study period, leaving 42 patients for the final evaluation. 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: “The patients were randomized to undergo 30 or 60 min of TUMT, or to sham treatment (14, 16 and 14 men, respectively).” Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	The participants were blinded: “study where the patients were unaware of the type of treatment given.” No information about blinding of personnel.
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.”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	No information about blinding however the outcomes are unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’.
Incomplete outcome data (attrition bias) Retreatment	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’.
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’.
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.