Kimberly-Clark DryNites Paediatric Nocturnal Enuresis Study

• Research type

  Research Study

• Full title

  Effect of use of DryNites® absorbent pants on the rate of spontaneous resolution of paediatric nocturnal enuresis (NE)

• IRAS ID

  275273

• Contact name

  Adam Ellery

• Contact email

  a.ellery@nhs.net

• Sponsor organisation

  Kimberly-Clark

• Clinicaltrials.gov Identifier

  NCT04620356

• Duration of Study in the UK

  1 years, 6 months, 31 days

• Research summary

  Research Summary:
  This is an 8-week randomised, open-label, 2-arm, parallel-group Phase IV trial of use of DryNites® absorbent pants in children with monosymptomatic NE does not have a negative effect in children with a clinical diagnosis of monosymptomatic NE, and an optional 4-week extension period.

  This study aims to show that on the speed that children become dry, compared with removing absorbent pants. It also aims to show that using DryNites® improves the overall quality of life (QoL) and sleep quality of both children and their parents/carers.

  Children/parents/carers actively seeking help for NE can be recruited via specialist centres, clinician
  visits, referrals and collaboration with primary care providers.

  Approximately 120 participants aged 4-8 years from a total of 4-6 sites will be randomised in 3 countries (Belgium, Denmark, and the United Kingdom) over a 6-month enrolment period. Participants will be divided in 2 age groups of similar size (4–<6 years and ≥6–8 years old).

  This study will last up to 12 weeks and consists of 3 consecutive periods. Participant will be asked to come to 2 visits, one after the first 4 weeks and another one after the 2nd period, after 8 weeks of participation, at which point participant will be asked for optional continuation for a further 4-weeks period.

  Study specific mandated clinic visits will be required as part of the participation in this study. Participants will be reimbursed for their travel expenses.

  Dry and wet nights will be captured every day from the start of the run-in period to discontinuation of the study through an electronic diary, accessible through the parent’s/carer’s own device (smart phone, tablet or computer).

  QoL and sleep questionnaires will be completed in electronic format on-site during the clinic visits from randomisation onwards. The perception of DryNites® attributes, compared to previously used absorbent products will be evaluated through 2 specific questionnaires designed for this study, at study entry (for previous absorbent pants/nappies) and at the end of the run-in period (for DryNites®).

  Summary of Results

  Overall Conclusions Among the families of children randomized to the intervention, a marked percentage (21.4%) could not tolerate stopping the use of the absorbent pants and discontinued the study, many citing QoL challenges associated with unmanaged NE. At the end of the intervention period, the group of children who tolerated the discontinuation of absorbent pants had a lower number of wet nights equivalent to a decrease of 2 wet nights per week. In post-hoc analyses on an intention-to-treat population, the rate of full response in the group that stopped wearing pants was 12.9% (9/70), with an overall percentage of responders (defined as those with 50.0% improvement of symptoms compared to baseline) of 20.0% (14/70). NE resolution in the group that continued wearing pants was observed for 2.9% of the participants (1/35; with the only responder being a full responder). The overall response in the intervention arm was observed within the first 2 weeks of the discontinuation of the absorbent pants (with the initial effect being mainly composed of partial responders). In conclusion, post-hoc analyses confirmed the findings of the primary outcome analysis, despite differential dropout and missing data. The full and partial response sub-groups were presented in both study arms; these percentages are important for clinicians when choosing treatment options. Furthermore, time-to-response and time-to-dropout analyses highlighted important implications for the intervention and its potential implementation in clinical practice. Compared to the group that stopped wearing absorbent pants at night, improved QoL, improved daytime activity (less tiredness) and sleep quality (more rested) metrics were observed overall for children and parents/caregivers in the group randomized to continue the use DryNites Pyjama Pants, particularly among the Extension Analysis Set. There was high acceptability of DryNites among parents/caregivers, as observed by the responses to the DryNites Questionnaire at the end of the run-in period. No safety concerns were identified over the course of the study.
  The relatively small percentage of full responders in the intervention arm must be considered in light of the possible negative impact on QoL and sleep quality experienced by children and parents soon after stopping the use of absorbent pants at night. While stopping the use of absorbent pants may present an attractive strategy for the treatment of NE, families should be aware of the potential impact of unmanaged NE on the QoL of their children, and themselves, when considering treatment options. It would be advisable for children who attempt discontinuation of absorbent pants, but do not achieve improvement in NE within 2 weeks, to continue wearing absorbent pants to improve their QoL, sleep and emotional well-being, as well as that of their parents or caregivers

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  19/NE/0370

• Date of REC Opinion

  20 Jan 2020

• REC opinion

  Favourable Opinion