Incontinence, UrinaryABDENCT04260646
Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children
A study testing Enuresis Alarm Rodger and Timer watch (Rodger) and Timer watch (Rodger) in people with Incontinence, Urinary and Enuresis, Nocturnal, run by Aalborg University Hospital at 4 sites in Denmark.
Trial summary
The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
- What is being tested?
- Enuresis Alarm Rodger and Timer watch (Rodger) and Timer watch (Rodger)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 May 2017to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-14 years
- Completed "Tørfisk" (Danish version of the Bower "Dry pie" Incontinence diary 1) and bladder diary (containing frequency and volume of voiding, fluid intake through 48 hours as well as 7 days night registering of nocturnal urine production (NUP) and wet nights.)
- A minimum of 2 wet days per week
- A minimum of 2 wet nights per week.
- Average NUP (aNUP) on wet nights of less than 130 % of expected bladder capacity (EBC=30*(age+1))
- Obtained oral and written informed consent from the participant and both custody holders.
Who cannot join
- Known renal- or urinary tracts anomalies that affects the incontinence
- Ongoing urinary tracts infection (UTI)
- Ongoing obstipation defined by ROM IV criteria
- Glycosuria or proteinuria
- Previously received treatment with anticholinergics
- Previously received treatment with enuresis alarm
- Sign on neurological or structural cause of the incontinence
- Reduced compliance for alarm treatment defined as use of the alarm less than 80 % of the nights of the treatment period.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Dept pediatrics, Aalborg University Hospital
Aalborg, 9000
dept Pediatrics, Aarhus University Hospital
Aarhus N, 8200
Børneafdelingen, Herning
Herning, 7400
Dept pediatrics, North Denmark Regional Hospital Hjoerring Hjoerring
Hjørring, 9800
About this study
Official title: Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. The study will include children who suffers for combined daytime incontinence and enuresis and referred to one of the pediatric departments were offed to participate. Participants are randomized to 8 weeks treatment with either enuresis alarm and timer watch assist urotherapy or solely timer watch assisted urotherapy.
Read the detailed description
Urinary incontinence are common disorders of school age children. Approximately 3.8 - 16.9 % of first grade children suffer from daytime incontinence (DUI) depending on the definitions. Half of the children with DUI suffers for enuresis (NE) too. The background for combined DUI and enuresis is in most children functional overactive bladder (OAB).
At present DUI is treated first with urotherapi, if insufficient bladder modulating drugs are added. When daytime continence is achieved, the enuresis is handled using (in cases of small bladder capacity) an enuresis alarm.
Whether daytime continence is a prerequisite for treating NE or whether enuresis alarm may positively influence DUI treatment has not been studies in a RCT previously.
The aim of this study is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating children with combined daytime incontinence and enuresis. Thus the hypothesis are:
- That the enuresis alarm therapy is beneficial in DUI treatment.
- That it is possible to treat enuresis before daytime continence has been achieved
Methods: The study is a randomized controlled trial. The participants will be approx. 90 children that suffers from combined enuresis and daytime urinary incontinence. The participants will be equally randomized to 8 week of timer watch assisted urotherapy 1) with or 2) without addition of enuresis alarm treatment. The study includes 3 outpatient visits and 2 phone contacts.
The participants will complete bladder diaries as well as drypie and nocturnal urine production registrations. Also registrations on number and time of enuresis will be recorded for the alarm group children. All children will be provided a timer watch.
- Conditions
- Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
- Being tested
- Enuresis Alarm Rodger and Timer watch (Rodger), Timer watch (Rodger)
- Medical subject headings
- Urinary Incontinence, Nocturnal Enuresis, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enuresis Alarm Rodger and Timer watch (Rodger)Device
Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
Timer watch (Rodger)Device
Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
| Study group | Role | What they receive |
|---|---|---|
| Standard Urotherapy without enuresis alarm | Active comparator | Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. Receives: Device: Timer watch (Rodger) |
| Standard Urotherapy with enuresis alarm | Experimental | Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. In addition an enuresis alarm will be provided and worn by the participants during the night. Receives: Device: Enuresis Alarm Rodger and Timer watch (Rodger); Device: Timer watch (Rodger) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daytime incontinence-score
Incontinence-score calculated from Drypie scale between 0-21
Measured: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Change in Relative number of wet nights
Number of wet nights pr week
Measured: Will be calculated from registrations at baseline and week 8 of intervention
Secondary outcomes (2)
Change in MVV (maximal voided volume)
maximal voided volume from bladder diary in ml
Measured: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Change in Daytime urinary incontinence episodes (DUI episodes)
Daytime urinary incontinence episodes by bladder diary (episodes per day)
Measured: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 May 2017
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regional Hospital West Jutland, Regionshospital Nordjylland
- Responsible party
- Principal investigator, Søren Hagstrøm, MD PhD, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260646
- Sponsor's protocol ID
- N-20170005
- Acronym
- ABDE
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
- ClinicalTrials.gov ID
- NCT04260646
- Acronym / sponsor ID
- ABDE / N-20170005
- Conditions
- Incontinence, Urinary, Enuresis, Nocturnal, Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regional Hospital West Jutland, Regionshospital Nordjylland
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. The study will include children who suffers for combined daytime incontinence and enuresis and referred to one of the pediatric departments were offed to participate. Participants are randomized to 8 weeks treatment with either enuresis alarm and timer watch assist urotherapy or solely timer watch assisted urotherapy.
Detailed description
Urinary incontinence are common disorders of school age children. Approximately 3.8 - 16.9 % of first grade children suffer from daytime incontinence (DUI) depending on the definitions. Half of the children with DUI suffers for enuresis (NE) too. The background for combined DUI and enuresis is in most children functional overactive bladder (OAB).
At present DUI is treated first with urotherapi, if insufficient bladder modulating drugs are added. When daytime continence is achieved, the enuresis is handled using (in cases of small bladder capacity) an enuresis alarm.
Whether daytime continence is a prerequisite for treating NE or whether enuresis alarm may positively influence DUI treatment has not been studies in a RCT previously.
The aim of this study is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating children with combined daytime incontinence and enuresis. Thus the hypothesis are:
- That the enuresis alarm therapy is beneficial in DUI treatment.
- That it is possible to treat enuresis before daytime continence has been achieved
Methods: The study is a randomized controlled trial. The participants will be approx. 90 children that suffers from combined enuresis and daytime urinary incontinence. The participants will be equally randomized to 8 week of timer watch assisted urotherapy 1) with or 2) without addition of enuresis alarm treatment. The study includes 3 outpatient visits and 2 phone contacts.
The participants will complete bladder diaries as well as drypie and nocturnal urine production registrations. Also registrations on number and time of enuresis will be recorded for the alarm group children. All children will be provided a timer watch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Urotherapy without enuresis alarm | Active comparator | Device: Timer watch (Rodger)Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. |
| Standard Urotherapy with enuresis alarm | Experimental | Device: Enuresis Alarm Rodger and Timer watch (Rodger), Device: Timer watch (Rodger)Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. In addition an enuresis alarm will be provided and worn by the participants during the night. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 5-14 years
- Completed "Tørfisk" (Danish version of the Bower "Dry pie" Incontinence diary 1) and bladder diary (containing frequency and volume of voiding, fluid intake through 48 hours as well as 7 days night registering of nocturnal urine production (NUP) and wet nights.)
- A minimum of 2 wet days per week
- A minimum of 2 wet nights per week.
- Average NUP (aNUP) on wet nights of less than 130 % of expected bladder capacity (EBC=30*(age+1))
Key exclusion criteria (8 listed)
- Known renal- or urinary tracts anomalies that affects the incontinence
- Ongoing urinary tracts infection (UTI)
- Ongoing obstipation defined by ROM IV criteria
- Glycosuria or proteinuria
- Previously received treatment with anticholinergics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enuresis Alarm Rodger and Timer watch (Rodger)Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals | Device | Standard Urotherapy with enuresis alarm |
| Timer watch (Rodger)Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals | Device | Standard Urotherapy with enuresis alarm, Standard Urotherapy without enuresis alarm |
Primary outcome
Change in Daytime incontinence-score
Time frame: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Incontinence-score calculated from Drypie scale between 0-21
Change in Relative number of wet nights
Time frame: Will be calculated from registrations at baseline and week 8 of intervention
Number of wet nights pr week
2 secondary outcomes
Change in MVV (maximal voided volume)
Time frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Change in Daytime urinary incontinence episodes (DUI episodes)
Time frame: Will be calculated from 48h registrations at baseline and at week 8 of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enuresis Alarm Rodger and Timer watch (Rodger) and Timer watch (Rodger) in people with Incontinence, Urinary and Enuresis, Nocturnal, run by Aalborg University Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daytime incontinence-score (time frame: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.