Ability to Awaken in Nonmonosymptomatic Enuresis | NCT02845648

Studies
Ability to Awaken in Nonmonosymptomatic Enuresis

NCT02845648

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

119Actual

Phase

Not provided

Conditions

Enuresis, Nocturnal, 2 (Disorder)

Interventions

anticholinergic

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 12, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwanjin Park, professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anticholinergic	Drug	Initial anticholinergic therapy to all patients		Vesicare BUP-4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

Exclusion Criteria:

any urological abnormalities including neuropathic bladder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Children with primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwanjin PArk, Pf.	Seoul National University Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Oct 12, 2020
Reset	Nov 3, 2020
Release	Nov 4, 2020
Reset	Dec 3, 2020

Submission Tracking

Estimated Results First Submitted Date

Oct 12, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 12, 2020			Nov 3, 2020
Nov 4, 2020

Condition Browse Module

MeSH Terms

ID	Term
D004775	Enuresis

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018680	Cholinergic Antagonists
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D018678	Cholinergic Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided