| Methods |
Design: three group parallel trial
Purpose: examine the effect of transurethral microwave thermotherapy (TUMT) on benign prostatic hyperplasia |
| Participants |
Patients: out‐patients suffering from benign prostatic hyperplasia
Baseline comparability: NS |
| Interventions |
Placebo: TUMT with no microwave emission
Untreated: no TUMT
Experimental: TUMT with machine on
(Co‐intervention: NS) |
| Outcomes |
American Urologist Association's symptom score and Minimum urethral opening pressure (mm H20)
Maximum urinary flow rate
Post‐void residual urine volume
Maximum detrusor pressure |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'selecting ... numbered ... balls from a sealed bag' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The treatment of the first two groups was 'double‐blind'...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 82 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
