Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

Last updated: October 21, 2024
Sponsor: Kimberly-Clark Corporation
Overall Status: Completed

Phase

N/A

Condition

Nocturia

Frequent Nighttime Urination (Nocturia)

Urinary Incontinence

Treatment

DryNites Pyjama Pants

Clinical Study ID

NCT04620356
KCC-DN-001
  • Ages 4-8
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged between 4-8 years at the time of enrollment

  • Have a clinical diagnosis of monosymptomatic primary NE

  • Have been dry in the day for >/= 6 months prior to enrollment

  • Have on average no more than 1 dry night per month during the past 6 months atenrollment

  • Have an informed consent signed by the their parent(s)/carer(s)

Exclusion

Exclusion Criteria:

  • Children in foster/court care

  • Have implemented any previous intervention to address NE (use of prescribed alarmschedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappiesfor > 7 days in the previous 6 months

  • Have secondary NE

  • Have wetting in the day

  • Have faecal soiling

  • Have known urinary tract disease

  • Have diabetes

  • Receive any regular intake of medication

  • Have a known developmental/neurological disorder

  • Have links to Kimberly-Clark of any kind (including family relations employed byKimberly-Clark, holding stocks or share in Kimberly-Clark)

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: DryNites Pyjama Pants
Phase:
Study Start date:
February 21, 2020
Estimated Completion Date:
June 28, 2023

Study Description

Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.

Connect with a study center

  • Aalborg Universitetshospital, Borne og Ungeafdelingen

    Aalborg, Connor Downs 9000
    United Kingdom

    Site Not Available

  • Aarhus Universitetshospital, Center for Borneinkontinens

    Arhus N, Connor Downs 8200
    United Kingdom

    Site Not Available

  • UZ Gent

    Ghent, Connor Downs 9000
    United Kingdom

    Site Not Available

  • Mounts Bay Medical

    Connor, Haley TR27 5DT
    United Kingdom

    Site Not Available

  • Mounts Bay Medical

    Connor Downs, TR27 5DT
    United Kingdom

    Site Not Available

  • Essex Partnership University NHS Foundation Trust

    Essex, SS4 1RB
    United Kingdom

    Site Not Available

  • Siddarth Marnekar

    Hull, HU12 8JD
    United Kingdom

    Site Not Available

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