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

April 1, 2022 updated by: Kimberly-Clark Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Connor Downs, United Kingdom, TR27 5DT
        • Not yet recruiting
        • Mounts Bay Medical
        • Contact:
        • Principal Investigator:
          • Adam Ellery
      • Essex, United Kingdom, SS4 1RB
        • Not yet recruiting
        • Essex Partnership University NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Rachael Edwards
      • Hull, United Kingdom, HU12 8JD
        • Recruiting
        • Siddarth Marnekar
        • Contact:
        • Principal Investigator:
          • Margaret Ikpoh
    • Connor Downs
      • Aalborg, Connor Downs, United Kingdom, 9000
        • Not yet recruiting
        • Aalborg Universitetshospital, Borne og Ungeafdelingen
        • Contact:
        • Principal Investigator:
          • Soren Hagstrom
        • Sub-Investigator:
          • Kristina Thorsteinsson
      • Arhus N, Connor Downs, United Kingdom, 8200
        • Recruiting
        • Aarhus Universitetshospital, Center for Borneinkontinens
        • Contact:
        • Principal Investigator:
          • Soren Rittig
        • Sub-Investigator:
          • Cecilie Jorgensen
        • Sub-Investigator:
          • Anders Breinbjerg
        • Sub-Investigator:
          • Konstantinos Kamperis
      • Ghent, Connor Downs, United Kingdom, 9000
        • Recruiting
        • UZ Gent
        • Contact:
        • Principal Investigator:
          • Johan Vande Walle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Children in foster/court care
  • Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for > 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 by Kimberly-Clark, holding stocks or share in Kimberly-Clark)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DryNites arm
Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night.
Device: DryNites Pyjama Pants
DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
No Intervention: No Pants arm
Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wet nights
Time Frame: Last week of the 4-week intervention period
Average number of wet nights
Last week of the 4-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of urinary incontinence on emotional wellbeing of child as assessed by PinQ survey
Time Frame: Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
The Paediatric Incontinence Questionnaire (PinQ) measures the emotional impact of urinary incontinence in children with bladder dysfunction. It is comprised of 20 urinary incontinence quality of life questions and rated on a 5-point scale with 0 = No and 4 = All the time. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater emotional impact of urinary incontinence on the child's quality of life.
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Impact of child nighttime enuresis on parent/carer quality of life as assessed by the WHOQoL-BREF Questionnaire
Time Frame: Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
The World Health Organization Quality of Life Brief Version (WHOQoL-BREF) questionnaire measures an individual's perceptions of well-being in the context of their culture and value systems and their personal goals, standards and concerns. It is comprised of 26 items grouped into four domains (physical health, psychological, social relationships, and environment) along with 2 separate items asking the respondent about overall perception of quality of life and the individual's overall perception of their health. Each question is rated on a 5-point scale with 1 corresponding to the most negative response and 5 corresponding to the most positive response. Higher scores indicate a higher quality of life.
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Child daytime sleepiness as assessed by PDSS Questionnaire
Time Frame: Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
The Paeditric Daytime Sleepiness Scale (PDSS) questionnaire measures daytime sleepiness in children. It is comprised of 8 items assessing daytime sleepiness and rated on a 5-point scale with 0 = Never and 4 = Always/Very Often. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater daytime sleepiness.
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Parent/Carer fatigue as assessed by CIS Questionnaire
Time Frame: Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
The Checklist Individual Strength (CIS) questionnaire measures fatigue-related problems. It is compromised of 20 statements on fatigue-related problems respondents might have experienced in the past two weeks, and respondents indicate on a 7-point scale to what extent the particular statement applies to him or her. The CIS measures four dimensions of fatigue (fatigue severity, concentration problems, reduced motivation, and activity). A CIS total score is calculated by adding the 4 dimensions, and higher scores indicate greater fatigue.
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimberly-Clark Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCC-DN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nocturnal Enuresis

Clinical Trials on DryNites Pyjama Pants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe