Abstract General Information

Title

THE EFFECTS OF DISCONTINUING NIGHT-TIME PROTECTION IN CHILDREN WITH NOCTURNAL ENURESIS – A MULTI-CENTRE, INTERNATIONAL RANDOMIZED CONTROLLED TRIAL

Introduction and objective

The use of absorbent pyjama pants (PP) to manage the impact of nocturnal enuresis (NE) is controversial. No prospective scientific evidence currently supports that using PP sustains NE severity, nor that discontinuation reduces the severity. Our primary objective was to examine the effect of discontinuing PP on NE severity (wet nights in the last intervention week). Secondary objectives were to assess quality of life (QoL) measures.

Method

Treatment-naïve children aged 4–8 years with severe mono-symptomatic NE were eligible for inclusion. After a 4-week run-in period, sleeping with PP, eligible (7/7 wet nights before randomization) participants were randomised 2:1 to discontinue or continue PP for 4-8 weeks. The study was funded by the Kimberly-Clark corporation.

Results

In total 105 children (43 girls, mean age 5.6 [1.13]) were randomised (no-pants group n=70, pants group n=35). In the no-pants group, 15 children (21%) discontinued early due to distress caused by NE. In the intention-to-treat population (n=105), full response in the no-pants group was achieved by 13% (n=9), and 3% (n=1) in the pants group (p=0.054). Partial response (≥50% improvement from baseline) was achieved by 20% in no-pants group (n=14), compared to n=1 (3%) in the pants group (p<0.05). Improvement could be detected within the first two weeks of intervention in responders in the no-pants group. The difference in number of wet nights in the last 7 days of intervention in favour of the no-pants group was 2.3 (1.54-3.08), p<0.05, with mean wet nights of 6.71 in the pants group and 4.42 in the no-pants group. In secondary analysis, negative QoL impact seemed largest in the extension period, suggesting a larger impact of the intervention over time, in the no-pants group. Compared to the no-pants group, improved QoL and better sleep (less tiredness and waking) were observed overall for children and parents/caregivers in the pants group, particularly in the extension.

Conclusion

About 13% of families achieved full resolution of NE in the no-pants group compared to 3% in the pants group. Removal of PP significantly decreases incidence of enuresis episodes after 4 weeks, detectable within 2 weeks in responders. Discontinuation was intolerable in a large proportion of families (21%). Recommendations for future guidelines may include attempting discontinuation and advising that children who do not achieve improvement within 2 weeks, revert to PP to sustain their QoL and sleep quality, as well as that of their parents or carers.