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

The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.

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 that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.

Study Overview

• Status: Completed
• Conditions: Enuresis, Nocturnal
• Intervention / Treatment: Drug: Desmopressin; Device: Conditional alarm

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) following the same protocol.

According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings.

Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings.

Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Søren Rittig, Professor; Phone Number: 0045 78 45 15 23; Email: rittig@clin.au.dk
• Study Contact Backup: Name: Cecilie Siggaard Jørgensen, PhD student; Phone Number: 0045 61 16 16 06; Email: cecilie.siggaard@clin.au.dk

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis Sint-Jan Brugge
  • Ghent, Belgium, 9000
    • Ghent University Hospital
• China
  • Henan
    • Zhengzhou, Henan, China
      • First Affiliated Hospital of Zhengzhou University
• Denmark
  • Jylland
    • Aalborg, Jylland, Denmark, 9000
      • Aalborg University Hospital
    • Aarhus, Jylland, Denmark, 8200
      • Aarhus University Hospital
• Poland
  • Gdańsk, Poland, 80-952
    • University Clinical Centre in Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment without evaluating the home recordings, medicin.; Children will receive desmopressin without evaluating the home recordings.	Drug: Desmopressin; The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).; Other Names: Minirin, melt
Experimental: Treatment without evaluating the home recordings, alarm.; Children will receive conditional alarm without evaluating the home recordings.	Device: Conditional alarm; Eight weeks of treatment.
Active Comparator: Treatment based on home recordings, polyuria.; Children with polyuria based on the home recordings will receive desmopressin.	Drug: Desmopressin; The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).; Other Names: Minirin, melt
Active Comparator: Treatment based on home recordings, reduced bladder capacity.; Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.	Device: Conditional alarm; Eight weeks of treatment.
Active Comparator: Treatment based on home recordings, both.; Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.	Drug: Desmopressin; The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).; Other Names: Minirin, melt; Device: Conditional alarm; Eight weeks of treatment.
Active Comparator: Treatment based on home recordings, none.; Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.	Drug: Desmopressin; The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).; Other Names: Minirin, melt; Device: Conditional alarm; Eight weeks of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of children who responded to the treatment	Evaluated by home recordings	Eight weeks
The number of children achieving complete dryness (complete responders)	Evaluated by home recordings	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wet nights	Evaluated by home recordings	Eight weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University Ghent; First Affiliated Hospital of Zhengzhou University, China; University Clinical Centre in Gdansk, Poland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: DRYCHILD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No