Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis (BAAT)
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|ClinicalTrials.gov Identifier: NCT03812094|
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : December 30, 2021
Enuresis is the scientific term for bedwetting. Modern research has established three pathogenic mechanisms as crucial:
- Excessive urine production at night (nocturnal polyuria).
- Detrusor over activity. The bladder may contract regardless of whether it is full or not.
- Difficulties to arouse from sleep and will not wake up when the bladder is full or contracts.
Children with daytime incontinence usually suffer from detrusor over activity and many of them are constipated. The reason for this connection is probably partly anatomical; constipated children have to use the rectum as a storage space, and the chronically distended rectum will compress the bladder from behind.
The link between constipation and enuresis (as opposed to daytime incontinence) is less clear although it is logically plausible. Our experience is that some enuretic children become dry at night just by treatment of constipation, but this is yet not supported by sufficient evidence The standard primary treatment of enuresis - as reflected by global consensus guidelines - rests upon three pillars. The recommended first step is 1) bladder advice. The next step, if the child is still wet at night, is either 2) the antidiuretic drug desmopressin or 3) the sleep-modifying enuresis alarm.
The underlying idea behind basic bladder advice is that the child is taught to more actively take command over the bladder by voiding according to a regular daytime schedule, using correct voiding posture and spread fluid intake evenly across the day. The rationale behind the recommendation of this strategy is that is the established cornerstone of the treatment of daytime incontinence and that detrusor over activity is a pathogenic factor common to both conditions. By influencing bladder, function during the day it is assumed that nocturnal bladder function will also normalize. The problem is a glaring lack of evidence.
Our primary aims with this study is to better understand which roles basic bladder advice, constipation therapy and/or the enuresis alarm play in the first-line therapy of enuresis.
|Condition or disease||Intervention/treatment||Phase|
|Nocturnal Enuresis||Device: Enurad 400 Behavioral: Basic Bladder advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trail|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis - a Randomized Controlled Trial|
|Actual Study Start Date :||July 1, 2019|
|Actual Primary Completion Date :||June 1, 2021|
|Actual Study Completion Date :||June 1, 2021|
Active Comparator: Basic Bladder advice
Basic bladder advice as given from a pre-specified document, study nurse
Behavioral: Basic Bladder advice
Pre-specified Basic bladder advice
Active Comparator: Alarm
Alarm Enurad 400
Device: Enurad 400
No Intervention: No treatment
No treatment during study period.
- Reduction of wet nights per two weeks as compared to baseline enuresis frequency. [ Time Frame: 14 days mesurement before study compered to 14 days in treatment week 7 and 8 ]Respons to treatment is at least 3 nights per two weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812094
|Center for Clinical Research Dalarna|
|Falun, Sweden, 79182|
|Study Director:||Malin Borgström||Center for Clinical Research Dalarna|