children with neurogenic detrusor overactivity MedDRA version: 14.1 Level: PT Classification code 10041524 Term: Spina bifida System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Toviaz
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: fesoterodinefumaraat
Other descriptive name: FESOTERODINE
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
UZ Leuven-Department of Urology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - the study population consists of 20 patients - age: 5-16y - bodyweight: >20kg - stable neurogenic detrusor overactivity prooved with urodynamic investigation - all of them need intermittent catheterisation - the study patients take already oxybutynin+/-tolterodine - they will be all informed and one of the parents need to sign an informed consent when they agree with the participation of their child Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - high sensibility for fesoterodin, tolterodin or oxybutinin - pinda/soya allergy - galactose-intolerance, lactase-deficiency, glucose-galactose-malabsorption - pathologies/surgeries that can disturb the absorption of fesoterodine: gastrectomy, stomach-retention, hypoperistalsis, myasthenia gravis, intestinal obstruction, severe colitis ulcerosa, toxic megacolon - surgeries who raise the risk of fesoterodine or who interact with the study results eg urinary sfincterotomy, artificial urinary sfincter, bladder augmentation - comorbidities who raise the risk of fesoterodine or who interact with the study results eg bladderlithiasis, closed-angle glaucoma, severe liver dysfunction(child pugh C) - autonomic dysreflexia - autonomic neuropathy - transurethral catheterization for 4 weeks prior to the study - relevant abnormal laboratory parameters(hematology, biochemic) - relevant abnormal heart frequency or an irregular heartbeat - medication who can interact with fesoterodine: CYP3A4-inductors or strong CYP3A4-inhibitors for 3 weeks prior to/during the study or the possibility that they need to start this type of medication during the study - botox treatment 9 months prior to the study - antispasmodic, parasympatomimetic, cholinergic medication during the study - intermittent or unstable use of diuretics, alfa-blockers, tricyclic antidepressants, neuroleptica - use of other experimental medication 4 weeks prior to the study - electrostimulation therapy that was started during the month prior to the study - pregnancy - family members of the investigators of the study take caution when there is: - mild liver dysfunction - kidney dysfunction - higher risk at long QT(low potassium, bradycardy, medication that prolong QT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficiency and tolerance of fesoterodine in comparison with intravesical oxybutynin +/- tolterodine in children with neurogenic detrusor overactivity.;Secondary Objective: not applicable;Primary end point(s): maximum cystometric bladder capacity= maximal tolerable cystometric capacity - until voiding - until leaking - at 40 cmH2O ;Timepoint(s) of evaluation of this end point: week 1 and 7, before and after admission of fesoterodine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): urodynamic investigation: - detrusor pressure at maximal bladder capacity - bladder volume at first involuntary detrusor contraction(IDC)(= detrusor pressure higher than 10cmH2O) miction diary: - mean number of catheterizations/24hrs - mean volume per catheterization - mean number of incontinence episodes/24hrs Anamnestic: - most frequent complications of anticholinergics: dry mouth, dry eyes, constipation, nausea, hyperthermia, behavioral changes, decreased cognitive function, headache, seizures, somnolence, accommodation disorder, blurred vision, amblyopia Urinalysis: urinary tract infection Vital signs: body temperature, heart rate, tension Clinical laboratory evaluations: liver function, kidney function, hematology, biochemics Pregnancy test when there is a possibility Post-void residual volume when there is more than 1 urinary tract infection during the study ;Timepoint(s) of evaluation of this end point: history, medication, vital signs, clinical examination,blood, pregnancytest,urinanalysis:DAY14 until -1 mictiondiary I:3 DAYS before WEEK 1 urodynamics, child behavior checklist, snellen test, push up test: WEEK 1 miction diary II: WEEK 2 day 4-7, the period that they stop their current anticholinergics (oxy bladder instillations+/- tolt) WEEK 3: stop oxy and tolt, start feso 25kg-40kg 4mg/day, >40kg 8mg/day, inform how the first intake went WEEK 4: complications? WEEK 6: complications? miction diary III:3 DAYS before WEEK 8 WEEK 8:urodynamics, complications?, vital signs, clinical examination, blood, urinanalysis, child behavior checklist, snellen test, push up test STOP feso,restart oxy+/- tolt WEEK 10:late complications?preference of the patient? | — |
Countries
Belgium
Contacts
Public ContactGuy Bogaert
UZ Leuven-Department of Urology
Outcome results
None listed