Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis
BAAT
The Efficacy of Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis - a Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Enuresis is the scientific term for bedwetting. Modern research has established three pathogenic mechanisms as crucial:
- 1.Excessive urine production at night (nocturnal polyuria).
- 2.Detrusor over activity. The bladder may contract regardless of whether it is full or not.
- 3.Difficulties to arouse from sleep and will not wake up when the bladder is full or contracts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 22, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedDecember 30, 2021
December 1, 2021
1.9 years
January 7, 2019
December 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of wet nights per two weeks as compared to baseline enuresis frequency.
Respons to treatment is at least 3 nights per two weeks
14 days mesurement before study compered to 14 days in treatment week 7 and 8
Study Arms (3)
Basic Bladder advice
ACTIVE COMPARATORBasic bladder advice as given from a pre-specified document, study nurse
Alarm
ACTIVE COMPARATORAlarm Enurad 400
No treatment
NO INTERVENTIONNo treatment during study period.
Interventions
Eligibility Criteria
You may qualify if:
- Children 6-11 Years
- Enuresis (monosymtomatic enuresis)
You may not qualify if:
- Day incontinence (nonmonosymtomatic enuresis)
- Neurological disease
- Urological malformation
- Kidney disease
- Previous alarm treatment for enuresis
- Don´t want to stop medication whit Vasopressin (if currant)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dalarna County Council, Swedenlead
- Uppsala Universitycollaborator
Study Sites (1)
Center for Clinical Research Dalarna
Falun, 79182, Sweden
Related Publications (1)
Borgstrom M, Bergsten A, Tunebjer M, Hedin Skogman B, Neveus T. Daytime urotherapy in nocturnal enuresis: a randomised, controlled trial. Arch Dis Child. 2022 Jun;107(6):570-574. doi: 10.1136/archdischild-2021-323488. Epub 2022 Jan 24.
PMID: 35074830DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Malin Borgström
Center for Clinical Research Dalarna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, associate professor
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 22, 2019
Study Start
July 1, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
December 30, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share