Status:

COMPLETED

The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

University Ghent

First Affiliated Hospital of Zhengzhou University, China

Conditions:

Enuresis, Nocturnal

Eligibility:

All Genders

6-14 years

Phase:

PHASE4

Brief Summary

The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. The hypothesis is...

Detailed Description

This is a randomized, controlled study. This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) followin...

Eligibility Criteria

Inclusion

  • Age 6-14 years.
  • Three or more wet nights per week regarding the home registrations.

Exclusion

  • Ongoing constipation and/or faecal incontinence.
  • Daytime symptoms such as urgency, frequency or incontinence.
  • Recurrent urinary tract infections.
  • Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated.
  • Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
  • Former operations in the urinary tract.
  • Prior or ongoing treatment with alarm, desmopressin or anticholinergics.
  • Ongoing medication that may interfere with the parameters tested.
  • Pregnant or lactating girl.
  • Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH.
  • Hypersensitivity / allergy to substances in the tablets.

Key Trial Info

Start Date :

October 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 3 2023

Estimated Enrollment :

324 Patients enrolled

Trial Details

Trial ID

NCT03389412

Start Date

October 1 2017

End Date

January 3 2023

Last Update

August 2 2023

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Algemeen Ziekenhuis Sint-Jan Brugge

Bruges, Belgium, 8000

2

Ghent University Hospital

Ghent, Belgium, 9000

3

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

4

Aalborg University Hospital

Aalborg, Jylland, Denmark, 9000