Ability to Awaken in Nonmonosymptomatic Enuresis

Enuresis, Nocturnal, 2 (Disorder) Clinical Trial

Official title:

The Ability to Awaken Can be Improved With Control of Lower Urinary Tract Symptoms in Children With Nonmonosymptomatic Enuresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845648
• Other study ID #: SNUHPEDURO-01
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 27, 2016
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic enuresis and evaluate the potential implication of improved AA for treatment response prediction.

Description:

Nocturnal enuresis is associated with three main etiologies, including nocturnal polyuria secondary to abnormal anti-diuretic hormone levels, low bladder capacity related to lower urinary tract dysfunction, and sleep disorders causing problems in arousal. Among them, the association between enuresis and lower urinary tract symptoms (LUTS) has gained importance. If these two conditions coexist, the diagnosis is nonmonosymptomatic enuresis (NME). The reported prevalence of LUTS among enuretic patients ranges widely from 21% to 99%. Moreover, it was reported that spontaneous resolution can be prolonged, and some cases of NME are likely to become refractory if treated like monosymptomatic enuresis (ME) cases. A possible explanation for this may be the presence of bladder dysfunction that is not addressed properly by the standard treatment of ME. However, this explanation is only speculative.

By showing a paradoxical increase in light sleep and higher cortical arousal index in enuretic children with reduced bladder capacity, one of the reason for impaired ability to awaken (AA) in enuretic patients may lie in the chronic stimulation of the bladder. This kind of bladder dysfunction leading to an abnormal bladder-brain dialogue has been further elaborated by an experiment showing brain dysfunction in the ventrolateral periaqueductal gray matter as a result of the experimental reduction of the bladder capacity. If this is true for enuretic children, we may be able to improve arousal (improved AA) by increasing their bladder capacity.

Based on this hypothesis, the present study aimed to evaluate to the effects of anticholinergic therapy with standard urotherapy on improvement of AA and show the effect of improved AA on treatment response in children with NME.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

Exclusion Criteria:

• any urological abnormalities including neuropathic bladder

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal, 2 (Disorder)
• Lower Urinary Tract Symptoms
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• anticholinergic
Initial anticholinergic therapy to all patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ability to awaken	Visual analog scale for ability to awaken (grade 1 = wake up before bed-wetting, grade 2 = wake up after bed-wetting, and grade 3 = failure of waking up around bed-wetting)	Baseline, 3 months and 6 months	No
Secondary	Change of enuresis events	enuresis events as assessed by modified dysfunctional voiding symptoms score questionnaire (number of wet-nights per week, range 0 to 7)	Baseline, 3 months and 6 months	No