Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis

NCT03812094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-30

No results posted yet for this study

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.

Conditions

  • Nocturnal Enuresis

Interventions

DEVICE

Enurad 400

Alarm treatment

BEHAVIORAL

Basic Bladder advice

Pre-specified Basic bladder advice

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER
  • Dalarna County Council, Sweden

    lead OTHER

Principal Investigators

  • Malin Borgström · Center for Clinical Research Dalarna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812094 on ClinicalTrials.gov