NCT02845648

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

July 12, 2016

Last Update Submit

July 27, 2016

Conditions

Enuresis, Nocturnal, 2 (Disorder)

Keywords

anticholinergicsawakener

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change of enuresis events

    Baseline, 3 months and 6 months

Interventions

anticholinergicDRUG

Initial anticholinergic therapy to all patients

Also known as: Vesicare, BUP-4

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

You may qualify if:

  • primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

You may not qualify if:

  • any urological abnormalities including neuropathic bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Enuresis

Interventions

Cholinergic AntagonistsSolifenacin Succinate

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kwanjin PArk, Pf.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 27, 2016

Study Start

July 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share