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

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ClinicalTrials.gov Identifier: NCT03389412
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Our 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.


Condition or disease Intervention/treatment Phase
Enuresis, Nocturnal Drug: Desmopressin Device: Conditional alarm Phase 4

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: We will evaluate the home recordings and choose treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled study
Masking: Single (Participant)
Masking Description: The children and the parents will not know, if there treatment is based on home recordings or not.
Primary Purpose: Treatment
Official Title: The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 received 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 Name: 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 Name: 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.
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 Name: Minirin, melt
Device: Conditional alarm
Eight weeks of treatment.


Outcome Measures

Primary Outcome Measures :
  1. Reduction in number of wet nights. [ Time Frame: Eight weeks. ]
    Evaluated by home recordings.


Secondary Outcome Measures :
  1. Reduction in nocturnal urine production. [ Time Frame: Eight weeks. ]
    Evaluated by home recordings.

  2. Increase in bladder capacity (maximal voided volume). [ Time Frame: Eight weeks. ]
    Evaluated by home recordings.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, hyponatraemia or SIADH.
  • Hypersensitivity / allergy to substances in the tablets.
Contacts and Locations

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): NCT03389412


Contacts
Contact: Søren Rittig, Professor 0045 78 45 15 23 rittig@clin.au.dk
Contact: Cecilie Siggaard Jørgensen, PhD student 0045 61 16 16 06 cecilie.siggaard@clin.au.dk

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Lien Dossche, MD    003293320648    lien.dossche@uzgent.be   
China, Henan
First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Jianguo Wen       wenjg@hotmail.com   
Denmark
Aarhus University Hospital Recruiting
Aarhus, Jylland, Denmark, 8200
Contact: Cecilie Siggaard Jørgensen, PhD student    0045 61161606    cecilie.siggaard@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
University Ghent
First Affiliated Hospital of Zhengzhou University, China
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03389412     History of Changes
Other Study ID Numbers: DRYCHILD
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

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

Additional relevant MeSH terms:
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs