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

NCT04620356 | Completed Results

• 1 other identifier: KCC-DN-001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

• Wet Nights

  Average number of wet nights

  Last week of the 4-week intervention period

Secondary Outcomes (4)

• Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)

  Assessment will be done at each study clinic visit (Day 56 +/- 7)

• Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire

  Assessment will be done at each study clinic visit (Day 56 +/- 7)

• Child Daytime Sleepiness as Assessed by PDSS Questionnaire

  Assessment will be done at each study clinic visit (Day 56 +/- 7)

• Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)

  Assessment will be done at each study clinic visit (Day 56 +/- 7 )

Study Arms (2)

DryNites arm

EXPERIMENTAL

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

No Pants arm

NO INTERVENTION

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.

Interventions

DryNites Pyjama Pants DEVICE

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.

DryNites arm

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kimberly-Clark Corporation: lead

Study Sites (2)

Mounts Bay Medical

Connor, Haley, TR27 5DT, United Kingdom

Location

Siddarth Marnekar

Hull, HU12 8JD, United Kingdom

Location

Related Publications (1)

• Breinbjerg A, Kamperis K, Thorsteinsson K, Jorgensen CS, Dossche L, Rayner J, Zhang J, Rodrigues DG, Borch L, Hagstrom S, Tekgul S, Walle JV, Rittig S. Discontinuing absorbent pants in children with bedwetting: a randomized controlled trial. Eur J Pediatr. 2024 May;183(5):2443-2453. doi: 10.1007/s00431-024-05502-w. Epub 2024 Mar 12.

  PMID: 38472381 DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Science Manager
• Organization: kimberlyClark

debora.rodrigues@kcc.com

+55 11 45034500

Study Officials

• Søren Riting

  Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: November 9, 2020
• Study Start: February 21, 2020
• Primary Completion: January 28, 2023
• Study Completion: June 28, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)