Overactive BladderNCT02704013
Urinary Biomarkers in Overactive Bladder in Children
A study testing Oxybutynin in people with Overactive Bladder, run by Children's Hospital Zagreb at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- neurogenic bladder
- constipation or fecal incontinence
- urolithiasis, depression, eating disorders or cardio-metabolic diseases
- prior use of anticholinergic treatment during the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Urinary Neurotrophin and Cytokine Levels in Diagnosis and Management of Overactive Bladder in Children
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.
- Conditions
- Overactive Bladder
- Being tested
- Oxybutynin
- Keywords
- Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children
- Medical subject headings
- Urinary Bladder, Overactive, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
Also called Driptane
Anticholinergic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after start of intervention
Secondary outcomes (6)
Long-term success
Relapse is defined as more than 1 symptom recurrence monthly, continued success is de-fined as no relapse in 6 months after the interruption of treatment.
Measured: 6 months after stop of intervention
Bladder wall thickness
Bladder wall thickness will be measured using ultrasonography.
Measured: 6 months after start of intervention
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Improvement is defined by increase in total and subscale scores by more than defined minimally clinical important difference for PedsQL 4.0 Generic Core questionnaire.
Measured: 6 months after start of intervention
Urinary neurotrophins
Urine samples will be collected at urge sensation before and 6 months after start of intervention. Urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) levels normalized to urinary creatinine will be measured.
Measured: 6 months after start of intervention
Urinary cytokines
Urine samples will be collected at urge sensation before and 6 months after start of intervention. Urinary inflammatory cytokines (MCP-1, MCP-2, MCP-3, CaCL-13) levels normalized to urinary creatinine will be measured.
Measured: 6 months after start of intervention
Urodynamics
Urodynamic study will be investigated prior and 6 months after start of intervention. Maximum detrusor pressure will be assessed.
Measured: 6 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital for Infectious Diseases, Croatia
- Responsible party
- Sponsor
- Investigators
- Slaven Abdovic, MD, PhD, Principal investigator, Children's Hospital Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704013
- Sponsor's protocol ID
- pOAB-CHZ-01
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Urinary Neurotrophin and Cytokine Levels in Diagnosis and Management of Overactive Bladder in Children
- ClinicalTrials.gov ID
- NCT02704013
- Acronym / sponsor ID
- pOAB-CHZ-01
- Conditions
- Overactive Bladder
- Keywords
- Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital ZagrebUniversity, hospital or other
- Collaborators
- University Hospital for Infectious Diseases, Croatia
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Drug: OxybutyninPatients 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxybutyninAlso: DriptaneAnticholinergic | Drug | Intervention |
Primary outcome
Initial success
Time frame: 6 months after start of intervention
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 secondary outcomes
Long-term success
Time frame: 6 months after stop of intervention
Bladder wall thickness
Time frame: 6 months after start of intervention
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Time frame: 6 months after start of intervention
Urinary neurotrophins
Time frame: 6 months after start of intervention
Urinary cytokines
Time frame: 6 months after start of intervention
Urodynamics
Time frame: 6 months after start of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slaven Abdovic, MD, PhD principal investigator
Children's Hospital Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutynin in people with Overactive Bladder, run by Children's Hospital Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Slaven Abdovic, MD, PhD (+385911144333, sabdovic@gmail.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial success (time frame: 6 months after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.