Roehrborn 1998.

Study characteristics
Methods	Study design: prospective, randomized study Study dates: not reported Setting: outpatient, multicenter centre, national Country: USA
Participants	Inclusion criteria: men with: Age ≥ 55 years Score 13 points or more on the American Urological Association symptom index (AUA SI) 2 subsequent flow rates with peak urinary flow rate of 12 mL/s or less Voided volume > 125 mL. Serum prostate‐specific antigen (PSA) had to be < 10 ng/mL (monoclonal assay) Prostate volume between 25 and 100 mL Bladder neck to verumontanum distance > 30 mm Written informed consent Exclusion criteria: not reported Total number of participants randomized: 220 Group 1 (n = 147) TUMT Age, mean (SD): 66.3 (6.5) years AUA SI (0 – 35), mean (SD): 23.6 (5.6) AUA PI (0 – 28), mean (SD): 18.6 (5.8) BPH II (0 – 13), mean (SD): 7.2 (2.7) QOL score (0 – 6), mean (SD): 4.3 (1.0) Voided volume, mean (SD): 254 (82) mL Residual urine, mean (SD): 79.7 (70.1) mL PSA, Mean (SD): 3.1 (2.7) ng/mL PFR, mean (SD): 7.7 (2.0) mL/s Prostate volume, mean (SD): 48.1 (16.2) mL Group 2 (n = 73) Sham Age, mean (SD): 66 (5.8) years AUA SI (0 – 35), mean (SD): 23.9 (5.6) AUA PI (0 – 28), mean (SD): 18.6 (6.0) BPH II (0 – 13), mean (SD): 7.3 (3.1) QOL score (0 – 6), mean (SD): 4.3 (1.1) Voided volume, mean (SD): 251 (92) mL Residual urine, mean (SD): 67.5 (64.4) mL PSA, Mean (SD): 2.8 (2.0) ng/mL PFR, mean (SD): 8.1 (2.0) mL/s Prostate volume, mean (SD): 50.5 (18.1) mL
Interventions	Group 1 (n = 147) TUMT The Dornier Urowave (second‐generation microwave therapy device), can deliver up to 90 W of power and has an integrated water‐cooling circuit. The safety threshold was set at 50 °C in the urethra and at 42.5 °C in the rectum Group 2 (n = 73) Sham: sham‐treated participants received a 60‐minute, preprogrammed sham treatment cycle with the catheter in place Co‐interventions: All participants had negative urine cultures before treatment and were given peritreatment antibiotic prophylaxis (investigators’ choice). After treatment, an indwelling Foley catheter was inserted and left in place for 2 to 5 days, depending on logistics
Outcomes	Urologic symptom scores How measured: AUA‐SI (0 to 35 points) Time points measured: baseline, 1, 3, and 6 months Time points reported: baseline, 1, 3, and 6 months Subgroups: none Quality of Life How measured: AUA‐SI subscore (0 to 6 points) Time points measured: baseline, 1, 3, and 6 months Time points reported: baseline, 1, 3, and 6 months Subgroups: none Major and minor adverse events (including ejaculatory and erectile function) How measured: Adverse events were solicited from participants during and after treatment as well as at each follow‐up visit. Adverse events were designated as treatment‐related or unrelated to treatment by the investigator Time points measured: during treatment, 72 hrs after treatment and up to 6 months Time points reported: during treatment, 72 hrs after treatment and up to 6 months Subgroups: none Acute urinary retention How measured: not reported Time points measured: baseline, 1, 3, and 6 months Time points reported: 6 months Subgroups: none Relevant outcomes not reported in this study Retreatment Indwelling urinary catheter: not applicable since “an indwelling Foley catheter was inserted and left in place for 2 to 5 days, depending on logistics” (all participants).
Funding sources	Funded by Dornier MedTech, Atlanta, Georgia
Declarations of interest	Not available
Notes	A secondary report states that quality of life was also measured by another scale (0 ‐ 21), but it is not clear which scale was used.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: The investigators describe a random component in the sequence generation process. Quote: “The physician administering the treatment opened the centrally provided randomisation envelope immediately before treatment.”
Allocation concealment (selection bias)	Low risk	Comment: Participants and investigators enrolling participants could not foresee assignment. Quote: “The physician administering the treatment opened the centrally provided randomisation envelope immediately before treatment.”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: Blinding of participants and key study personnel was ensured, and it was unlikely that the blinding could have been broken. Quote: “They were made aware that in this trial there would be an active/sham randomizations at a ratio of 2:1. Furthermore, patients were made aware that a ‘‘subset’’ of patients would have interstitial temperature monitoring by way of inserting a needle through the perineum into the prostate. However, for ethical reasons, only actively treated patients received such monitoring. Thus, the patients were effectively blinded as to whether or not they underwent active or sham treatment despite the fact that only the actively treated patients had interstitial temperature monitoring.”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Comment: Blinding of participants and key study personnel was ensured, and it was unlikely that the blinding could have been broken. Quote: “The treating physician and assistant were excluded from the follow‐up evaluation of the patient. The physician and/or nurse involved in the follow‐up evaluation was not present in the room during treatment.”
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Comment: Blinding of participants and key study personnel was ensured, and it was unlikely that the blinding could have been broken. Quote: “The treating physician and assistant were excluded from the follow‐up evaluation of the patient. The physician and/or nurse involved in the follow‐up evaluation was not present in the room during treatment.”
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: Insufficient reporting of attrition/exclusions to permit judgment of ‘Low risk’ or ‘High risk'. Quote: “For the various parameters, between 124 and 130 of the actively treated patients (86% to 88%) were available for 6‐month follow‐up; in the sham‐treated group, between 65 and 67 (89% to 92%) of patients were available for 6‐month follow‐up.”
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.