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Discontinuing absorbent pants in children with bedwetting: a randomized controlled trial
Anders Breinbjerg1,2, Konstantinos Kamperis3,4, Kristina Thorsteinsson5
1Department of Pediatrics, Aarhus University Hospital, Palle Juul-Jensens blvd. 99, 8200, Aarhus N, Denmark. andbre@clin.au.dk.
Insights
Discontinuing absorbent pyjama pants (APP) in children with severe nocturnal enuresis (NE) led to fewer wet nights. However, this intervention
Area of Science:
- Pediatric Urology
- Sleep Medicine
- Quality of Life Research
Background:
- Severe childhood nocturnal enuresis (NE) affects many children, often necessitating nighttime protection.
- Absorbent pyjama pants (APP) are commonly used for managing NE, but their long-term impact on spontaneous resolution is unclear.
- Understanding the effects of discontinuing APP is crucial for guiding treatment decisions in pediatric NE management.
Purpose of the Study:
- To investigate the efficacy of discontinuing absorbent pyjama pants (APP) in children with severe nocturnal enuresis (NE).
- To evaluate the impact of APP discontinuation on the rate of wet nights, quality of life (QoL), and sleep.
- To assess the clinical relevance and potential side effects of stopping APP use in pediatric NE.
Main Methods:
- A multicenter, parallel, randomized controlled trial involving 105 children (4-8 years) with severe NE.
- Participants underwent a 4-week run-in period using APP, followed by randomization to either continue or discontinue APP for 4-8 weeks.
- Primary outcome: difference in wet nights during the final intervention week; secondary outcomes: QoL and sleep.
Main Results:
- Children who discontinued APP experienced significantly fewer wet nights (2.3 fewer nights, p<0.0001) compared to those who continued.
- A ~10% complete resolution rate was observed in the no-pants group, with clinical improvement noted within 2 weeks.
- APP discontinuation negatively impacted QoL and sleep in the extension period, though not in the core 4-week period; 21% stopped due to stress.
Conclusions:
- Discontinuing absorbent pyjama pants (APP) shows a statistically significant reduction in wet nights for children with severe nocturnal enuresis (NE).
- While a ~10% complete resolution rate was observed, the clinical relevance is debatable, and the intervention requires motivated families.
- APP discontinuation may negatively affect quality of life and sleep, and should be approached cautiously, with no severe side effects reported.
Abstract:
The objective of this study is to examine the effect of discontinuing wearing protective garments (absorbent pyjama pants - APP) in children with severe childhood nocturnal enuresis (NE). The study employs a multicenter, parallel, randomized controlled trial. Following a 4-week run-in period, participants were randomly allocated in a 2:1 group allocation to discontinue or continue using APP. The research was conducted across seven European pediatric incontinence centers. The study included treatment-naïve children aged 4-8 years with severe (7/7 wet nights per week) mono-symptomatic NE, who had used nighttime protection for at least 6 months prior to the study. The study consisted of a 4-week run-in period (± 7 days), where all children slept wearing APP (DryNites®). At week 4 (± 7 days), if meeting randomization criteria (7/7 wet nights during the last week of run-in), participants were randomized to continue to sleep in APP or to discontinue their use for a further 4 weeks, with the option of another 4 weeks in the extension period. The primary outcome was the difference between groups of wet nights during the last week of intervention. Quality of life (QoL) and sleep were secondary endpoints. In total, 105 children (43 girls and 62 boys, mean age 5.6 years [SD 1.13]) were randomized (no-pants group n = 70, pants group n = 35). Fifteen children (21%) in the no-pants group discontinued early due to stress related to the intervention. Children in the no-pants group experienced fewer wet nights compared to the pants group during the last week (difference 2.3 nights, 95% CI 1.54-3.08; p < 0.0001). In the no-pants group, 20% responded to the intervention, of whom 13% had a full response. Clinical improvement was detected within 2 weeks. Sleep and QoL were reported as negatively affected by APP discontinuation in the extension period but not in the core period. Conclusion: A ~ 10% complete resolution rate was associated with discontinuing APP. While statistically significant, the clinical relevance is debatable, and the intervention should be tried only if the family is motivated. Response was detectable within 2 weeks. Discontinuing APP for 4-8 weeks was reported to negatively affect QoL and sleep quality. No severe side effects were seen.Trial registration: Clinicaltrials.gov Identifier: NCT04620356; date registered: September 23, 2020. Registered under the name: "Effect of Use of DryNites Absorbent Pyjama Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)."
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