Back to resultsEffect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Primary Purpose
Nocturnal Enuresis
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DryNites Pyjama Pants
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Enuresis
Eligibility Criteria
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)
Sites / Locations
- Aalborg Universitetshospital, Borne og Ungeafdelingen
- Aarhus Universitetshospital, Center for BorneinkontinensRecruiting
- UZ GentRecruiting
- Mounts Bay Medical
- Essex Partnership University NHS Foundation Trust
- Siddarth MarnekarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DryNites arm
No Pants arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wet nights
Average number of wet nights
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04620356
First Posted
September 23, 2020
Last Updated
April 1, 2022
Sponsor
Kimberly-Clark Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04620356
Brief Title
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Official Title
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kimberly-Clark Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DryNites arm
Arm Type
Experimental
Arm Description
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.
Arm Title
No Pants arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DryNites Pyjama Pants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wet nights
Description
Average number of wet nights
Time Frame
Last week of the 4-week intervention period
Secondary Outcome Measure Information:
Title
Impact of urinary incontinence on emotional wellbeing of child as assessed by PinQ survey
Description
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.
Time Frame
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Title
Impact of child nighttime enuresis on parent/carer quality of life as assessed by the WHOQoL-BREF Questionnaire
Description
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.
Time Frame
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Title
Child daytime sleepiness as assessed by PDSS Questionnaire
Description
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.
Time Frame
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
Title
Parent/Carer fatigue as assessed by CIS Questionnaire
Description
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.
Time Frame
Assessment will be done at each study clinic visit (Day 0, Day 28 +/- 7, Day 56 +/- 7 and Day 84 +/- 7 [optional])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siddarth Marnekar
Phone
+91 9850072432
Email
siddarth.marnekar@iqvia.com
Facility Information:
Facility Name
Aalborg Universitetshospital, Borne og Ungeafdelingen
City
Aalborg
State/Province
Connor Downs
ZIP/Postal Code
9000
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth B Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Soren Hagstrom
First Name & Middle Initial & Last Name & Degree
Kristina Thorsteinsson
Facility Name
Aarhus Universitetshospital, Center for Borneinkontinens
City
Arhus N
State/Province
Connor Downs
ZIP/Postal Code
8200
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth B Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Soren Rittig
First Name & Middle Initial & Last Name & Degree
Cecilie Jorgensen
First Name & Middle Initial & Last Name & Degree
Anders Breinbjerg
First Name & Middle Initial & Last Name & Degree
Konstantinos Kamperis
Facility Name
UZ Gent
City
Ghent
State/Province
Connor Downs
ZIP/Postal Code
9000
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth B Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Johan Vande Walle
Facility Name
Mounts Bay Medical
City
Connor Downs
ZIP/Postal Code
TR27 5DT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Adam Ellery
Facility Name
Essex Partnership University NHS Foundation Trust
City
Essex
ZIP/Postal Code
SS4 1RB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth B Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Rachael Edwards
Facility Name
Siddarth Marnekar
City
Hull
ZIP/Postal Code
HU12 8JD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth Marnekar
Phone
+919850072432
Email
siddarth.marnekar@iqvia.com
First Name & Middle Initial & Last Name & Degree
Margaret Ikpoh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
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