Abbou 1995.

Study characteristics
Methods	Study design: prospective, randomized study. Study dates: study dates not available Setting: outpatient, multicenter centre, national Country: France
Participants	Inclusion criteria: male participants: Age ≥ 50 years Voiding disorders for at least 3 months before inclusion No suspicion of prostatic cancer (assessed by digital rectal examination) Prostate weight between 30 and 80 g Peak Flow Rate (PFR) < 15mL/s for a voided volume ≥ 150 mL determined by two urine flow measurements Residual urine volume < 300 mL Prostate‐specific antigen (PSA) level <10ng/mL for a prostatic weight < 60 g or a PSA level < 15ng/mL for a prostatic weight ≥ 60 g Serum creatinine level < 160pmol/L No infection (assessed by bacteriological analysis of urine) Written informed consent Exclusion criteria: male participants: Undergone previous surgery on the prostate or bladder Mental incapacity Any chronic disease potentially hindering follow‐up Diabetes Participation in any clinical protocol within the last 3 months Any other urological disease Any medical treatment for voiding disorders within 15 days of inclusion Taken diuretics in the previous 3 months Anticoagulant therapy Allergy to lidocaine Colorectal disease. Total number of participants randomized: 200 Group 1: n = 66 Transurethral route hyperthermia Age, mean (SD): 65 (8) years Serum creatinine, mean (SD): 100 (19) mol/L Prostate weight, mean (SD): 45 (15) g PSA, mean (SD): 4.5 (2.7) ng/mL PFR, mean (SD): 10.4 (2.7)mL/s Group 2: n = 31 transurethral sham Age, mean (SD): 66 (7) years Serum creatinine, mean (SD): 92 (16) mol/L Prostate weight, mean (SD): 44 (11) g PSA, mean (SD): 4.2 (3) ng/mL PFR, mean (SD): 9.9 (2.5)mL/s Group 3: n = 65 Transrectal route hyperthermia Age, mean (SD): 66 (7) years Serum creatinine, mean (SD): 92 (19) mol/L Prostate weight, mean (SD): 45 (13) g PSA, mean (SD): 4.8 (2.8) ng/mL PFR, mean (SD): 9.8 (2.7)mL/s Group 4: n = 38 transrectal sham Age, mean (SD): 66 (7) years Serum creatinine, mean (SD): 90 (19) mol/L Prostate weight, mean (SD): 43 (15) g PSA, mean (SD): 5.0 (3.3) ng/mL PFR, mean (SD): 9.0 (3.3)mL/s
Interventions	Group 1 (n = 66) TUMT Three devices were used for transurethral treatment (Thermex II, Technorex, Israel: Prostcare, Brucker Spectrospin, France; BSD‐50. BSD Medical Corp, USA). Prostate temperature was monitored by an integrated microwave generator and controlled in each device through a fiber optic temperature monitor. All devices were used according to the manufacturer's instructions to deliver a temperature compatible with hyperthermia treatment (45 °C). Treatment was delivered in one session of 1 to 3 hs (depending on the device used). Group 2 (n = 31) Sham TUMT: Sham treatment consisted of a single session with the temperature maintained at 37 °C. Group 3 (n = 65) Transrectal route hyperthermia: Three devices were used for transrectal treatment (Prostathermer system, Biodan Medical Systems, Israel: Prostcare, Brucker Spectrospin, France: Primus, Tecnomatix Medical, Belgium). Prostate temperature was monitored by an integrated microwave generator and controlled in each device through a fiber‐optic temperature monitor. All devices were used according to the manufacturer's instructions to deliver a temperature compatible with hyperthermia treatment (45 °C). Treatment was delivered in six sessions of 1 to 3hs (depending on the device used) for each session over 3 weeks. Group 4 (n = 38) transrectal sham: sham treatment consisted of a single session with the temperature maintained at 37 °C. Co‐interventions: not reported
Outcomes	Urologic symptom scores How measured: Madsen score. Additionally, responders were participants showing excellent, good or moderate responses according to each of the criteria analyzed separately (Madsen score decrease >30%; a PFR >10 mL/s with a PFR increase > 30%). Time points measured: baseline, 3, 6, and 12 months Time points reported: baseline and 12 months Subgroups: none Retreatment How measured: number of participants with medical or surgical procedure (reported the numbers separately for each) Time points measured: during treatment and 1 to 4 weeks after treatment (early post treatment complications) Time points reported: during treatment and 1 to 4 weeks after treatment (early post treatment complications) Subgroups: none Major and minor adverse event/acute urinary retention How measured: number of patients with urethral bleeding, pain and urinary tract infection, acute urinary retention Time points measured: during treatment and 1 to 4 weeks after treatment (early post treatment complications) Time points reported: during treatment and 1 to 4 weeks after treatment (early post treatment complications) Subgroups: none Relevant outcomes not reported in this study Quality of life Erectile function Ejaculatory function Indwelling urinary catheter
Funding sources	This study was supported by a grant from the Comite d’Evaluation et de Diffusion des Innovations Technologiques (CEDIT), Assistance Publique‐Hopitaux de Paris. Devices were lent by the following companies: Biodan, Brucker, BSD, Direx, and Tecnomatix.
Declarations of interest	Not available
Notes	We only included transurethral active and sham groups for the purpose of this review. 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)	Low risk	Quote: “Randomization was stratified by the investigating centre and by approach (transrectal or transurethral), and was performed using permutation tables such that equal sample sizes were obtained for each type of approach, device and sham group.” The investigators describe a random component in the sequence generation process.
Allocation concealment (selection bias)	Unclear risk	Quote: “Patients were randomly allocated to a treatment in a single treatment centre after verification of the inclusion criteria.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: “Patients were not informed of their treatment, nor was the investigator who enrolled the patients.” 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: “Patients were not informed of their treatment, nor was the investigator who enrolled the patients.” 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: “Patients were not informed of their treatment, nor was the investigator who enrolled the patients.” Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life	High risk	There is an imbalance in numbers or reasons for missing data across intervention groups and potentially inappropriate application of simple imputation. Quote: “Patients lost to follow‐up were classified according to maximum bias (in the sham groups as 'responders' and in the hyperthermia groups as 'non‐responders').” Missing data only in group 2.
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events	High risk	There is an imbalance in numbers or reasons for missing data across intervention groups and potentially inappropriate application of simple imputation. Quote: “Patients lost to follow‐up were classified according to maximum bias (in the sham groups as 'responders' and in the hyperthermia groups as 'non‐responders').” Missing data only in group 2.
Incomplete outcome data (attrition bias) Retreatment	High risk	There is an imbalance in numbers or reasons for missing data across intervention groups and potentially inappropriate application of simple imputation. Quote: “Patients lost to follow‐up were classified according to maximum bias (in the sham groups as 'responders' and in the hyperthermia groups as 'non‐responders').” Missing data only in group 2.
Incomplete outcome data (attrition bias) Acute urinary retention	High risk	There is an imbalance in numbers or reasons for missing data across intervention groups and potentially inappropriate application of simple imputation. Quote: “Patients lost to follow‐up were classified according to maximum bias (in the sham groups as 'responders' and in the hyperthermia groups as 'non‐responders').” Missing data only in group 2.
Incomplete outcome data (attrition bias) Indwelling catheter	High risk	There is an imbalance in numbers or reasons for missing data across intervention groups and potentially inappropriate application of simple imputation. Quote: “Patients lost to follow‐up were classified according to maximum bias (in the sham groups as 'responders' and in the hyperthermia groups as 'non‐responders').” Missing data only in group 2.
Selective reporting (reporting bias)	Unclear risk	No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Other bias	Low risk	The study appears to be free of other sources of bias.