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Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis (BAAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812094
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : December 30, 2021
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Barbro Hedin Skogman, Dalarna County Council, Sweden

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trail
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Alarm treatment

No Intervention: No treatment
No treatment during study period.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Children 6-11 Years
  • Enuresis (monosymtomatic enuresis)

Exclusion criteria:

  • 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)

Information from the National Library of Medicine

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


Locations
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Sweden
Center for Clinical Research Dalarna
Falun, Sweden, 79182
Sponsors and Collaborators
Dalarna County Council, Sweden
Uppsala University
Investigators
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Study Director: Malin Borgström Center for Clinical Research Dalarna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barbro Hedin Skogman, MD, associate professor, Dalarna County Council, Sweden
ClinicalTrials.gov Identifier: NCT03812094    
Other Study ID Numbers: BAAT-01
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbro Hedin Skogman, Dalarna County Council, Sweden:
paediatric, children, treatment, intervention
Additional relevant MeSH terms:
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Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations