De Wildt 1996.

Study characteristics
Methods	Study design: parallel group randomized trial Study dates: Start date June 1991 – End date December 1992 Setting: outpatient, multicenter, international Country: Netherlands and the United Kingdom
Participants	Inclusion criteria: men: Aged > 45 years Complaining of symptoms of bladder outlet obstruction for > 3 months With a Madsen symptom score of > 8 Urinary free‐flow rate estimates of < 15 mL/s during 2 voids of > 150 mL Prostatic enlargement was confirmed by transrectal ultrasonography PSA or prostatic biopsy if necessary Exclusion criteria: Prostate cancer Prostatitis Urethral stricture Intravesical pathology (stones, neoplasm) Neurogenic bladder dysfunction Urinary tract infection Isolated enlargement of the middle lobe A residual urine volume of > 300 mL Use of drugs influencing bladder or prostate function Previous transurethral resection of the prostate or transurethral incision A metallic pelvic implant Disorders of blood flow or coagulation Diabetes mellitus Mental incapacity or inability to give informed consent Total number of participants randomized:93 men recruited but 90 were randomized (there is no further detail on the report) Group 1: n = 46 TUMT Mean age (SD): 66.3 (8.1) years Prostate volume (SD): 48.6 (16.6) mL Madsen score (SD): 13.7 (3.4) points Peak Flow (SD): 9.2 (2.5) mL/s PVR (SD): 93.9 (75.4) mL Voided fraction (SD): 74.9% (16.6) Group 2: n = 47 Sham Mean age (SD): 66.9 (6.0) years Prostate volume (SD): 49.0 (20.0) mL Madsen score (SD): 12.9 (3.1) points Peak Flow (SD): 9.6 (2.7) mL/s PVR (SD): 84.7 (66.1) mL Voided fraction (SD): 77.3% (15.7)
Interventions	Group 1 (n = 46): TUMT A single session of Prostatron treatment unit which consisted of a microwave generator, urethral applicator/cooler, fiberoptic temperature‐monitor, and couch. This study used the lower energy thermotherapy protocol (Prostasoft 2.0) Group 2 (n = 47): Sham Same procedure as in TUMT with a simulated program Co‐interventions: Not described
Outcomes	Urologic symptoms score How measured: Madsen symptom score. Responder analysis (> 50% decrease in Madsen score) Time points measured: baseline, 6, 12, 26, 52 weeks Time points reported: baseline, 6, 12, 26, 52 weeks (cross‐over after 3 months) Subgroups: none Major and minor adverse event How measured: major and minor adverse events Time points measured: not reported Time points reported: at 3 months Acute urinary retention How measured: number of participants that required a catheter after the procedure due to urinary retention Time points measured: not reported Time points reported: at 3 months Relevant outcomes not reported in this study Quality of life: ad‐hoc questionnaire (not validated). This included questions of sexual function Erectile function (see “quality of life”) Ejaculatory function (see “quality of life”) Retreatment: participants in the sham group were offered TUMT after 3 months. It is not clear if this was due to failure in the treatment. 2 participants in the TUMT group received TURP Indwelling urinary catheter
Funding sources	Not available
Declarations of interest	Not available
Notes	This study reports the trial by location and globally. The quality‐of‐life results are only available for the Netherlands report. After 3 months participants were offered TUMT. 27 participants in the Sham group and 4 participants in the TUMT group received a verum procedure, thus the results of this trial beyond 3 months are not included in this review. No contact information available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Patients were randomised after informed consent was obtained.” Comment: Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Quote: “Patients were randomised after informed consent was obtained.” Comment: Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered.” (first three months) Comment: Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered” (first three months). Comment: Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered” (first three months). Comment: Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were not available at 3 months for 3 participants in the Sham group (2 losses at follow‐up and 1 technical failure) and 2 participants in the TUMT group (underwent TURP).
Selective reporting (reporting bias)	Unclear risk	Protocol not available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Other bias	Low risk	No other sources of bias were identified.