A randomised controlled trial of a code-word enuresis alarm

Abstract

Objective: To compare a novel code-word alarm with a commercially available wireless alarm for treating enuresis Design: Randomised controlled trial with blinding of study personnel and outcome assessors Setting: A tertiary paediatric centre Patients: Children aged six to eighteen with at least three wet nights per week in the previous 6 months referred by doctors Outcomes: Primary outcome: the proportion who achieved a full response (14 consecutive dry nights) by 16 weeks. Secondary outcomes: change in frequency of wetting, duration of alarm training, percentage of wet nights that the child woke to the alarm, adherence to treatment, adverse events and satisfaction with treatment. Results: Of the 353 participants, 176 were assigned to the code-word alarm and 177 to control. At 16 weeks, 54% (95% CI, 47% to 61%) in the experimental group and 47% (95% CI, 40% to 55%) in the control group had achieved a full response (p=0.22), with 74% and 66% respectively attaining a 50% or more reduction in wetting frequency (p=0.14). The experimental group woke more often than the control group (median percentage of waking 88% versus 77%, p=0.003) and had greater reduction in wet nights (median reduction 10 versus 9 nights per fortnight). Fewer in the experimental group discontinued therapy before achieving a full response (27% versus 37% discontinued, p=0.04). There were no significant differences in relapse rates at 6 months, adverse events or satisfaction between the two alarms. In a post hoc subgroup analysis of children with monosymptomatic enuresis, more in the experimental group achieved a full response (66% versus 52%, p=0.047), with higher median percentage of waking (89% versus 79%, p=0.006) and greater reduction in wet nights (median reduction 12 versus 9 nights per fortnight). Conclusions: Although the code-word alarm increased waking, no difference in full response rates was demonstrated between the two alarms.