An interventional study of DryNites Pyjama Pants in Nocturnal Enuresis, sponsored by Kimberly-Clark Corporation. Completed at 2 sites in United Kingdom. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Kimberly-Clark Corporation · Not applicable, Interventional, and Other
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.
Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.
104 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
This study's enrollment of 105 is above the median of 68 across 76 interventional studies indexed under Nocturnal Enuresis.
Browse Nocturnal Enuresis studies →Kimberly-Clark Corporation is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Wet Nights
Average number of wet nights
Time frame: Last week of the 4-week intervention period
Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)
The PinQ will be used to assess the child's QoL. The PinQ is a validated cross-cultural continence-specific paediatric QoL questionnaire to assess children with bladder dysfunction, developed by Bower el al (Bower et al. 2006). It is available as self-rated and proxy versions. This will be completed by the child themselves in the older participant group and will be completed by the parent/carer on behalf of the child in the younger participant group. The PinQ measures the emotional impact that urinary incontinence has on a child. It consists of 20 urinary incontinence QoL related questions divided in 2 dimensions: intrinsic (14 items) and extrinsic (6 items), which are graded on a scale of 0 to 4 (0=No, 1=Hardly ever,2=Sometimes, 3=Often, 4=All the time) with a score range of 0 to 80. The total score indicates the impact urinary incontinence has on the child's QoL with the higher scores indicating a more significant effect.
Time frame: 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
The WHOQoL-BREF questionnaire (WHO 1996) will be completed directly by the parent/carer. . The WHOQoL-BREF questionnaire is derived from a larger instrument, the WHOQoL-100. It includes 26 items, grouped in 4 domains: Physical Heath, Psychological, Social Relationships, and Environment, and 2 separate items asking the crespondent about overall perception of QoL (item 1) and an individual's overall perception of their health (item 2). The scores of items 3, 4 and 5, which are negatively phrased, need to be reversed. The mean score of items within each domain is used to calculate the domain scores, which are converted into a 0-100 scale. Higher scores denote higher QoL. Where more than 20% of data is missing from an assessment, the assessment should be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than 2 items are missing from the domain, the domain score should not be calculated
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
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 scale ranges from 0 to 32. 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. Higher scores indicate greater daytime sleepiness, and were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness.
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)
The CIS questionnaire was used to assess the parents' sleep. It was completed directly by the parent/carer. The CIS consists of 20 statements on fatigue-related problems responders might have experienced in the past 2 weeks. A Likert scoring scheme from 1 to 7 ranging from 1-"no, that is not true" to 7-"yes, that is true" with items 2, 5, 6, 7, 8, 11, 12, 15 and 20 hold inverted scores. The total score ranges from 20 to 140. The questionnaire covers measures 4 dimensions of fatigue: Subjective fatigue severity (8 items), Concentration problems (5 items), Reduced motivation (4 items) and Physical activity (3 items). Dimensions can be analyzed separately, with higher scores indicating higher levels of subjective fatigue (8-56), reduced concentration (5-35), reduced motivation (4-28), and lower levels of physical activity (3-21). A total score over 76 is considered at risk of a fatigue disorder, while 36 provides the cutoff score on the subjective experience of fatigue sub-scale
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7 )
participants were recruited both from the community and from primary and tertiary care centers.
| Milestone | DryNites Arm | No Pants Arm |
|---|---|---|
| Started | 35 | 70 |
| Completed | 31 | 49 |
| Not completed | 4 | 21 |
Average number of wet nights
| wet nights per week | DryNites Arm | No Pants Arm |
|---|---|---|
| Wet Nights | 2.4 ± 2.21 | 4.6 ± 1.99 |
The PinQ will be used to assess the child's QoL. The PinQ is a validated cross-cultural continence-specific paediatric QoL questionnaire to assess children with bladder dysfunction, developed by Bower el al (Bower et al. 2006). It is available as self-rated and proxy versions. This will be completed by the child themselves in the older participant group and will be completed by the parent/carer on behalf of the child in the younger participant group. The PinQ measures the emotional impact that urinary incontinence has on a child. It consists of 20 urinary incontinence QoL related questions divided in 2 dimensions: intrinsic (14 items) and extrinsic (6 items), which are graded on a scale of 0 to 4 (0=No, 1=Hardly ever,2=Sometimes, 3=Often, 4=All the time) with a score range of 0 to 80. The total score indicates the impact urinary incontinence has on the child's QoL with the higher scores indicating a more significant effect.
| score on a scale | DryNites Arm | No Pants Arm |
|---|---|---|
| Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ) | 12.9 ± 8.17 | 15.2 ± 10.83 |
The WHOQoL-BREF questionnaire (WHO 1996) will be completed directly by the parent/carer. . The WHOQoL-BREF questionnaire is derived from a larger instrument, the WHOQoL-100. It includes 26 items, grouped in 4 domains: Physical Heath, Psychological, Social Relationships, and Environment, and 2 separate items asking the crespondent about overall perception of QoL (item 1) and an individual's overall perception of their health (item 2). The scores of items 3, 4 and 5, which are negatively phrased, need to be reversed. The mean score of items within each domain is used to calculate the domain scores, which are converted into a 0-100 scale. Higher scores denote higher QoL. Where more than 20% of data is missing from an assessment, the assessment should be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than 2 items are missing from the domain, the domain score should not be calculated
| score on a scale | DryNites Arm | No Pants Arm |
|---|---|---|
| Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire | 21.3 ± 3.13 | 21.5 ± 3.86 |
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 scale ranges from 0 to 32. 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. Higher scores indicate greater daytime sleepiness, and were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness.
| score on a scale | DryNites Arm | No Pants Arm |
|---|---|---|
| Child Daytime Sleepiness as Assessed by PDSS Questionnaire | 7.7 ± 3.63 | 8.5 ± 4.13 |
The CIS questionnaire was used to assess the parents' sleep. It was completed directly by the parent/carer. The CIS consists of 20 statements on fatigue-related problems responders might have experienced in the past 2 weeks. A Likert scoring scheme from 1 to 7 ranging from 1-"no, that is not true" to 7-"yes, that is true" with items 2, 5, 6, 7, 8, 11, 12, 15 and 20 hold inverted scores. The total score ranges from 20 to 140. The questionnaire covers measures 4 dimensions of fatigue: Subjective fatigue severity (8 items), Concentration problems (5 items), Reduced motivation (4 items) and Physical activity (3 items). Dimensions can be analyzed separately, with higher scores indicating higher levels of subjective fatigue (8-56), reduced concentration (5-35), reduced motivation (4-28), and lower levels of physical activity (3-21). A total score over 76 is considered at risk of a fatigue disorder, while 36 provides the cutoff score on the subjective experience of fatigue sub-scale
| score on a scale | DryNites Arm | No Pants Arm |
|---|---|---|
| Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire) | 43.7 ± 16.88 | 46.1 ± 22.75 |
Collected over 56 +/- 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DryNites Arm | 0/35 (0%) | 0/35 (0%) | 1/35 (2.9%) |
| No Pants Arm | 0/70 (0%) | 1/70 (1.4%) | 4/70 (5.7%) |
| Event | DryNites Arm | No Pants Arm |
|---|---|---|
| subglottic laryngitisRespiratory, thoracic and mediastinal disorders | 0/35 | 1/70 |
| Event | DryNites Arm | No Pants Arm |
|---|---|---|
| rashSkin and subcutaneous tissue disorders | 1/35 | 0/70 |
| genital candidiasis,Infections and infestations | 0/35 | 1/70 |
| pharyngitisRespiratory, thoracic and mediastinal disorders | 0/35 | 1/70 |
| subglottic laryngitisRespiratory, thoracic and mediastinal disorders | 0/35 | 1/70 |
| pyrexiaInfections and infestations | 0/35 | 1/70 |
| Age, Continuous(years) | DryNites Arm | No Pants Arm | Total |
|---|---|---|---|
| Mean | 5.4 ± 1.22 | 5.6 ± 1.09 | 5.6 ± 1.13 |
| Sex: Female, Male(Participants) | DryNites Arm | No Pants Arm | Total |
|---|---|---|---|
| Female | 14 | 29 | 43 |
| Male | 21 | 41 | 62 |
| Ethnicity (NIH/OMB)(Participants) | DryNites Arm | No Pants Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 35 | 69 | 104 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | DryNites Arm | No Pants Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 35 | 70 | 105 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Jan 2023, 35 months.
Results were first posted in Dec 2024, 1 year 10 months after primary completion.
Of 40 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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