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

Nocturnal Enuresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620356
• Other study ID #: KCC-DN-001
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Kimberly-Clark Corporation
• Contact: Siddarth Marnekar
• Phone: +91 9850072432
• Email: siddarth.marnekar[@]iqvia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Aalborg Universitetshospital, Borne og Ungeafdelingen	Aalborg	Connor Downs
United Kingdom	Aarhus Universitetshospital, Center for Borneinkontinens	Arhus N	Connor Downs
United Kingdom	Mounts Bay Medical	Connor Downs
United Kingdom	Essex Partnership University NHS Foundation Trust	Essex
United Kingdom	UZ Gent	Ghent	Connor Downs
United Kingdom	Siddarth Marnekar	Hull

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wet nights	Average number of wet nights	Last week of the 4-week intervention period
Secondary	Impact of urinary incontinence on emotional wellbeing of child as assessed by PinQ survey	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])
Secondary	Impact of child nighttime enuresis on parent/carer quality of life as assessed by the WHOQoL-BREF Questionnaire	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])
Secondary	Child daytime sleepiness as assessed by PDSS Questionnaire	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])
Secondary	Parent/Carer fatigue as assessed by CIS Questionnaire	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])