| Methods |
Design: three group parallel trial
Purpose: examine the effect of imipramine on enuresis |
| Participants |
Patients: army recruits referred to a 'Mental Hygiene Consultation Service' with the complaint of enuresis
Baseline comparability: yes (frequency of enuresis) |
| Interventions |
Placebo: tablet without imipramine
Untreated: no tablet (observational group)
Experimental: tablet with imipramine
(Co‐intervention: NS) |
| Outcomes |
Number of patients with reduced frequency of enuresis |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The subjects and experimenters were blind to which pills were the active medication' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 24 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
