NCT02704013

Brief Summary

It is a single-center, prospective, interventional, single-arm study. Aim is to investigate which variables are significantly correlated with prolonged anticholinergic treatment (\>6 months) in children with overactive bladder (OAB). Investigated variables will include urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics and treatment outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

March 4, 2016

Last Update Submit

March 9, 2016

Conditions

Overactive Bladder

Keywords

NeurotrophinsNerve Growth FactorBrain-Derived Neurotrophic FactorUrinary BiomarkersUrodynamicsAnticholinergicsChildren

Outcome Measures

Primary Outcomes (1)

  • Initial success

    Nonresponse is defined as a 0% to 49% decrease, partial response is defined as a 50% to 89% decrease, response is defined as a 90% or greater decrease and full response is defined as a 100% decrease or less than 1 symptom occurrence monthly. Symptoms include urgency, daily incontinence, increased daytime frequency, enuresis, nocturia. Symptom frequency will be assessed using validated diary.

    6 months after start of intervention

Secondary Outcomes (6)

  • Long-term success

    6 months after stop of intervention

  • Bladder wall thickness

    6 months after start of intervention

  • Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire

    6 months after start of intervention

  • Urinary neurotrophins

    6 months after start of intervention

  • Urinary cytokines

    6 months after start of intervention

  • +1 more secondary outcomes

Study Arms (1)

Intervention

OTHER

Patients with overactive bladder will receive anticholinergic therapy: oral oxybutynin in daily dose 0.2-0.5 mg/kg divided in two daily doses for 3 to 6 months depending on treatment outcome assessed 3 months after start of intervention.

Drug: Oxybutynin

Interventions

OxybutyninDRUG

Anticholinergic

Also known as: Driptane
Intervention

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • urgency with or without frequency, incontinence, enuresis, or nocturia
  • an unremarkable clinical examination
  • a minimum of 3 micturitions per day
  • informed oral and written consent from the child and both parents/legal guardian

You may not qualify if:

  • acute urinary tract infection
  • diseases of central or peripheral nerve system
  • anomalies of lumbosacral region
  • bladder outlet obstruction
  • operative procedures or anomalies of urinary or genital tract
  • hypercalcuria, diabetes mellitus, diabetes insipidus
  • neurogenic bladder
  • constipation or fecal incontinence
  • urolithiasis, depression, eating disorders or cardio-metabolic diseases
  • prior use of anticholinergic treatment during the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveHereditary Sensory and Autonomic Neuropathies

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Slaven Abdovic, MD, PhD

    Children's Hospital Zagreb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Slaven Abdovic, MD, PhD

CONTACT

+385911144333sabdovic@gmail.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 9, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

CR(1)