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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wet Nights | Average number of wet nights | Last week of the 4-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Riting | Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mounts Bay Medical | Connor | Haley | TR27 5DT | United Kingdom | ||
| Siddarth Marnekar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38472381 | Derived | 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. |
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Assessed for eligibility (n = 116). Excluded pré randomization(n = 11)
participants were recruited both from the community and from primary and tertiary care centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wet Nights | Average number of wet nights | Posted | Mean | Standard Deviation | wet nights per week | Last week of the 4-week intervention period |
|
56 +/- 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| subglottic laryngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| genital candidiasis, | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Science Manager | kimberlyClark | +55 11 45034500 | debora.rodrigues@kcc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2022 | Dec 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2020 | Dec 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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 | 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. | 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 | Assessment will be done at each study clinic visit (Day 56 +/- 7 ) |
| Hull |
| HU12 8JD |
| United Kingdom |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessment will be done at each study clinic visit (Day 56 +/- 7) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Assessment will be done at each study clinic visit (Day 56 +/- 7) |
|
|
|
| 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 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. | Posted | Mean | Standard Deviation | score on a scale | Assessment will be done at each study clinic visit (Day 56 +/- 7) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Assessment will be done at each study clinic visit (Day 56 +/- 7 ) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | 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. | 0 | 70 | 1 | 70 | 4 | 70 |
| pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| subglottic laryngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pyrexia | Infections and infestations | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |