D'Ancona 1998.
Study characteristics | ||
Methods |
Study design: parallel‐group randomized trial Study dates: January 1994 to August 1995 Setting: outpatient Country: Netherlands |
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Participants |
Inclusion criteria: men:
Exclusion criteria:
Sample size: 52 participants were randomized Group 1: n = 31 transurethral microwave thermotherapy (TUMT)
Group 1: n = 21 transurethral resection of the prostate (TURP)
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Interventions |
Group 1 (n = 31): TUMT Delivered using Prostatron device with software version 2.5, for 60 minutes increasing thermal dose up to 70 watts. Urethral and rectal thermal sensors provided feedback to prevent harms. Preparation included 100 mg diclofenac suppository and 2 mg of midazolam intramuscularly. If necessary, further intravenous sedation was administered. All participants left with an indwelling urinary catheter Group 2 (n = 21): TURP Performed by 2 experienced urologists with use of spinal anesthesia. The surgical capsule was reached circumferentially from the bladder neck to the verumontanum using 24 Ch. Resectoscopes Co‐interventions: not described |
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Outcomes |
Urologic symptom scores How measured: Madsen symptom score and IPSS Time points measured: 1, 3, 6 and 12 months Time points reported: 3, 6, 12 months Subgroups: none Major and minor adverse events How measured: episodes of urinary tract infection, hematuria Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: “repeat treatment” Time points measured: not reported Time points reported: not reported Subgroups: none Indwelling urinary catheter How measured: days of catheterization Time points measured: not reported Time points reported: median days and range Subgroups: none Relevant outcomes not reported in this study:
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Funding sources | Not available | |
Declarations of interest | Not available | |
Notes | No contact information available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Participants were randomised”. Comment: No information available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’. |
Allocation concealment (selection bias) | Unclear risk | Quote: “Participants were randomised.” Comment: No information available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Participants and personnel were not blinded. Outcomes are unlikely to be affected by lack of blinding. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Participants and personnel were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Outcome data were available for 44/52 participants at 1 year follow‐up, 2 were lost in the TURP group (bladder cancer and bladder neck sclerosis) and 6 in the TUMT group (1 underwent TURP, 1 died, 1 lost to follow up, 3 refused follow‐up). Unbalanced attrition. |
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 detected. |