Floratos 2001.

Study characteristics
Methods	Study design: parallel group randomized trial Study dates: start date January 1996 – end date March 1997 Setting: outpatient/inpatient, national, single‐center Country: The Netherlands
Participants	Inclusion criteria: Male participants aged 45 years and older with a prostate volume ≥ 30 cm3, prostatic urethral length ≥ 25 mm, a Madsen symptom score ≥ 8, maximum peak flow rate ≤ 15 mL/s and a postvoid residual ≤ 350 mL. Exclusion criteria: men with acute prostatitis or urinary tract infection, evidence of prostate carcinoma, an isolated obstructed prostatic middle lobe, diabetes mellitus, intravesical pathology, neurological disorders, or current treatment with drugs that may influence the bladder function. Total number of participants randomly assigned: 155 Group 1 (n = 82) TUMT Age (mean and range): 68 (54 to 77) years Prostate volume (mean and range): 42 (30 to 82) mL PSA (mean ± SD): not reported IPSS (mean and range): 21 (10‐28) Qmax (mean and range): 9.0 (5.0‐14.0) mL/second Group 2 (n = 73) TURP Age (mean and range): 66 (55‐77) years Prostate volume (mean and range): 48 (31‐84) mL PSA (mean ± SD): not reported IPSS (mean and range): 20 (11‐29) Qmax (mean and range): 8.4 ± 2.0mL/second
Interventions	Group 1 (n = 74): TUMT A one‐hour session was administered by the Prostatron device (EDAP Technomed, Lyon, France) with a second‐generation, high‐energy protocol (Prostasoft 2.5) with a maximum power of 70 W and a rectal threshold set at 43.5 °C. Patients were administered 40 mg of morphine sulfate orally 2 hours before treatment. All participants received an indwelling Foley catheter following an outpatient voiding trial. Patients also received co‐trimoxazole 960 mg twice a day for 5 days after treatment as prophylaxis. Group 2 (n = 73): TURP It was performed under spinal anaesthesia and intended to remove as much prostate tissue as possible and all patients received an indwelling Foley catheter, which was removed when hematuria decreased sufficiently, and the participant completed a successful voiding trial. Co‐interventions: not described
Outcomes	Urologic symptoms score How measured: IPSS score and Madsen score Time points measured: baseline, 3, 6, 12, 18, 24, and 36 months Time points reported: baseline, 12, 24, and 36 months Subgroups: none Quality of life How measured: 41‐item questionnaire designed for BPH patients Time points measured: baseline, 1, 3, 6, and 12 months Time points reported: baseline, 12, and 52 weeks Subgroups: none Retreatment How measured: narratively Time points measured: baseline, 3, 6, 12, 18, 24,and 36 months Time points reported: 6, 12, 18, 24, 30, and 26 months Major and minor adverse events How measured: major and minor adverse events Time points measured: not reported Time points reported: at 3 months Erectile function/Ejaculatory function (“Sexual function”) How measured: ad‐hoc questionnaire that assessed erections, sexual activities, orgasms, and satisfactions, among other aspects. Time points measured: baseline, 3 months and 1 year Time points reported: baseline, 3 months and 1 year Relevant outcomes not reported in this study: Erectile function Ejaculatory function (“Ejaculatory dysfunction pain” was reported) Acute urinary retention Indwelling urinary catheter (per protocol all participants were catheterized for 2 to 4 days)
Funding sources	Not available
Declarations of interest	Not available
Notes	No contact information available. We found a secondary report on sexual function with a greater attrition of data and with a slightly lower number of randomized individuals (147 participants versus 155 in the original report). Protocol: not available Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “All patients were randomized after informed consent had been obtained.” Judgement: Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Quote: “All patients were randomized after informed consent had been obtained.” Judgement: Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Open label study.
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Open label study.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Open label study. However, the outcomes are unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	Low risk	Quote: “Although […] 155 patients initially randomized, unfortunately because of the 10 who skipped the assigned treatment and 1 who died before the scheduled treatment, we have no follow‐up information.” Attrition was documented and was balanced (7 in the thermotherapy group and 11 in the TURP group).
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	Low risk	Quote: “Although […] 155 patients initially randomized, unfortunately because of the 10 who skipped the assigned treatment and 1 who died before the scheduled treatment, we have no follow‐up information.” Attrition was documented and was balanced (7 in the thermotherapy group and 11 in the TURP group).
Incomplete outcome data (attrition bias) Retreatment	Low risk	Quote: “Although […] 155 patients initially randomized, unfortunately because of the 10 who skipped the assigned treatment and 1 who died before the scheduled treatment, we have no follow‐up information.” Attrition was documented and was balanced (7 in the thermotherapy group and 11 in the TURP group).
Incomplete outcome data (attrition bias) Erectile function	High risk	Sexual function report. Quote: “A total of 66 patients undergoing transurethral microwave thermotherapy and 56 undergoing transurethral prostatic resection were evaluated.” (subset of participants)
Incomplete outcome data (attrition bias) Ejaculatory function	High risk	Sexual function report. Quote: “A total of 66 patients undergoing transurethral microwave thermotherapy and 56 undergoing transurethral prostatic resection were evaluated.” (subset of participants)
Incomplete outcome data (attrition bias) Indwelling catheter	Unclear risk	Not applicable (see comment on characteristics of included studies).
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.