Ability to Awaken in Nonmonosymptomatic Enuresis

NCT ID: NCT02845648

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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.

Conditions

Enuresis, Nocturnal, 2 (Disorder)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

anticholinergic

Initial anticholinergic therapy to all patients

Intervention Type: DRUG

Other Intervention Names

Vesicare; BUP-4

Eligibility Criteria

Inclusion Criteria

• primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

Exclusion Criteria

• any urological abnormalities including neuropathic bladder

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kwanjin Park

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwanjin PArk, Pf.

Role: STUDY_CHAIR

Seoul National University Hospital

Other Identifiers

SNUHPEDURO-01

Identifier Type: -

Identifier Source: org_study_id