The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
Overview
- Phase
- Phase 4
- Intervention
- Desmopressin
- Conditions
- Enuresis, Nocturnal
- Sponsor
- University of Aarhus
- Enrollment
- 324
- Locations
- 6
- Primary Endpoint
- The number of children achieving complete dryness (complete responders)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
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.
Investigators
Eligibility 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, hyponatremia or SIADH.
Arms & Interventions
Treatment without evaluating the home recordings, medicin.
Children will receive desmopressin without evaluating the home recordings.
Intervention: Desmopressin
Treatment without evaluating the home recordings, alarm.
Children will receive conditional alarm without evaluating the home recordings.
Intervention: Conditional alarm
Treatment based on home recordings, polyuria.
Children with polyuria based on the home recordings will receive desmopressin.
Intervention: Desmopressin
Treatment based on home recordings, reduced bladder capacity.
Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.
Intervention: Conditional alarm
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.
Intervention: Desmopressin
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.
Intervention: Conditional alarm
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.
Intervention: Desmopressin
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.
Intervention: Conditional alarm
Outcomes
Primary Outcomes
The number of children achieving complete dryness (complete responders)
Time Frame: Eight weeks
Evaluated by home recordings
The number of children who responded to the treatment
Time Frame: Eight weeks
Evaluated by home recordings
Secondary Outcomes
- Change in wet nights(Eight weeks)