Nørby 2002a.

Study characteristics
Methods	Study design: prospective, randomized stud. Study dates: May 1996 and November 1999 Setting: outpatient, multicenter, national Country: Denmark
Participants	Inclusion criteria: symptomatic benign prostatic hyperplasia (BPH) and: Age ≥ 50 years IPSS ≥ 7 QoL ≥ 3 Obstructed according to ICS nomogram or Qmax (free uroflowmetry) < 12 mL/s Able to understand project information Written consent Exclusion criteria: men with: Suspicion of prostate cancer Postvoid residual volume (PVR) > 350 mL or urinary catheter Prostatic urethra < 25 mm long Neurological diseases or diabetes with abnormal cystometry Previous prostate operation Ongoing UTI Previous diagnosis of rectal cancer Intake of medication known to influence voiding Severe peripheral arterial insufficiency Previous pelvic radiation therapy General health condition contraindicating surgery Total number of participants randomized: 118 Group 1: 48 Interstitial laser coagulation (ILC) Age, mean (SD): 65 (8) years Serum creatinine, mean (SD): 97 (13) umol/L Median prostate volume, Median (IQR): 44 (33 – 58) mL PSA, Median (IQR): 2.3 (1.7 – 6.3) ng/mL Qmax, mean (SD): 10.2 (4.0) mL/s Group 2: 46 transurethral microwave thermotherapy (TUMT) Age, mean (SD): 66 (7) years Serum creatinine, mean (SD): 99 (13) umol/L Median prostate volume, Median (IQR): 43 (35 – 79) mL PSA, Median (IQR): 3.3 (1.4 – 5.7) ng/mL Qmax, mean (SD): 9.1 (4.2) mL/s Group 3: 24 (control: TURP or TUIP) Age, mean (SD): 68 (7) years Serum creatinine, mean (SD): 99 (20) umol/L Median prostate volume, Median (IQR): 44 (35 – 50)mL PSA, Median (IQR): 2.2 (1.5 – 4.1) ng/mL Qmax, mean (SD): 9.6 (3.2)mL/s
Interventions	Group 1 (n = 48): “ILC was delivered by a MediLas 4100 Fibertom (Dornier, Germany), a Nd‐YAG laser with a wavelength of 1064 nm. The energy was delivered using an applicator with a quartz glass tip (length 20 mm, diameter 1.9 mm). The 3‐min radiation was used, thus applying 20 W for 30 s, 15 W for 30 s, 10 W for 30 s and 7 W for 90 s. Treatments were undertaken with a laser cystoscope (18 F) using saline as the irrigant. The fibre was placed deep within the lateral lobes at an angle in the plane of the urethra of 30º (to avoid heating the urethral mucosa). If a median lobe was present it was treated with one or two punctures in the direction of the bladder. Initially the intent was to apply one puncture per 10 mL of prostate tissue, but later the regimen became more aggressive, aiming at one puncture per 5 mL. All patients had a suprapubic tube placed at the start of the procedure and most also had a transurethral catheter for 12–24 h to reduce prostatic oedema. All patients received prophylactic antibiotics. Patients were discharged after removing the urethral catheter and scheduled to visit the outpatient clinic for removal of the suprapubic tube, generally at fixed intervals of 1–2 weeks.” Group 2 (n = 46): “TUMT was administered using the Prostatron® system; before treatment cystoscopy was used to exclude bladder pathology. Prostasoft v2.0 was chosen when the prostatic volume was < 30 mL and v2.5 in larger prostates. Treatment comprised 1 h sessions under local anaesthesia with Installagel® (Farco‐Pharma GmbH, Cologne, Germany); 1 h beforehand, 100 mg of diclofenac and 500 mg ciprofloxacin was administered. During treatment pethidine was given if necessary. If patients developed urinary retention after treatment a suprapubic or a transurethral catheter was inserted and the patient seen at weekly intervals until spontaneous voiding with an acceptable PVR (in general < 100 mL) was achieved.” Group 3 (n = 24): “Patients underwent TUIP or TURP according to the surgeons’ decision. The prostate was resected using a 26 F Iglesias resectoscope with a standard resection loop and 1.5% glycine for irrigation. TUIP comprised a unilateral incision in the 7 o’clock position starting proximal to the bladder neck and extending distally to the verumontanum. After surgery a three‐way irrigation catheter was inserted and first removed when bleeding had stopped. Prophylactic antibiotics were given according to the routine of the department.” Co‐interventions: “All treatments were administered by one of the two consultants or the senior registrar. Patients were treated under spinal or general anaesthesia.”
Outcomes	Urologic symptom scores How measured: IPSS Time points measured: baseline, 1, 3 and 6 months Time points reported: baseline and 6 months Subgroups: none Quality of life How measured: not reported Time points measured: baseline, 1, 3 and 6 months Time points reported: baseline and 6 months Subgroups: none Major and minor adverse event How measured: number of participants with bleeding necessitating transfusion Time points measured: 6 months Time points reported: 6 months Subgroups: none Retreatment How measured: number of participants undergoing TURP or other treatment Time points measured: 6 months Time points reported: 6 months Subgroups: none Erectile function How measured: To evaluate erectile function participants scoring 0 or 1 (i.e. normal or slightly reduced erectile capacity) were defined as ‘normal’, whereas participants scoring 2 or 3 (i.e. greatly reduced or no erectile function) were defined having decreased erectile capacity Time points measured: 6 months Time points reported: 6 months Subgroups: none Ejaculatory function How measured: number of patients with retrograde ejaculation Time points measured: 6 months Time points reported: 6 months Subgroups: none Acute urinary retention How measured: number of participants with persistent retention after treatment Time points measured: 6 months Time points reported: 6 months Subgroups: none Indwelling urinary catheter How measured: not reported Time points measured: 6 months Time points reported: 6 months (narratively) Subgroups: none
Funding sources	The study was supported by a grant from Vejle County, Denmark
Declarations of interest	Not available
Notes	ILC group data are not included in this review. Antibiotic regimen in ILC group was changed during the study because there was a high rate of UTI. “The study had to be stopped at the final date because of financial restrictions.”
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: 2:1:1: Randomization ‐ “A weighted randomisation was therefore chosen as the object was to gain maximum information about the new treatments.” Comment: Insufficient information about the sequence generation process to permit judgment of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias)	Unclear risk	Quote: “Patients were recruited from two centres and randomised at a 2:2:1 to TUMT, ILC or the control group.” Comment: Method of allocation concealment is not described in sufficient detail to allow a definite judgment
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding.
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	No blinding, but the outcomes ar not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding, and the outcomes are likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: “Analyses are presented on an intention‐to‐treat basis.”  Group 1: “Before ILC but after randomisation two patients had prostate cancer diagnosed and one had a urethral stricture. A further two patients declined surgery. One of these patients completed the IPSS at 6 months by mail contact. Thus, 44 patients were available for evaluation at 6 months.” Group 2: “All patients were followed at 6 months except one who developed an apoplexy at 4 months. One patient had TURP.” Group 3: “23 of 24 patients were treated according to the randomisation. One patient declined surgery. Two patients were excluded as the pathology revealed T1 prostate cancer.”
Selective reporting (reporting bias)	Unclear risk	No protocol available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Other bias	Low risk	The study appears to be free of other sources of bias.