This study compares intravesical oxybutynin and oral fesoteridine in children with a neurogenic overactive bladder. Both antimuscarinics lower the activity of the overactive bladder and by consequence lower the pressure in the bladder, what is important to protect the higher urinary tract system. Fesoterodine works more bladderspecific, that's why it's better tolerated than oxybutynin. 1 pill of fesoterodine a day would be more practical to use than 2 bladderinstillations of oxybutynin a day

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
INTERVENTION: Trade Name: Toviaz Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: fesoterodinefumaraat Other descriptive name: FESOTERODINE Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 8‐ Product Name: Oxybutynine.HCl 5mg/5ml Product Code: 110073 Pharmaceutical Form: Intravesical solution INN or Proposed INN: Oxybutynine.HCl 5mg/5ml CAS Number: 1508‐65‐2 Other descriptive name: OXYBUTYNIN HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Trade Name: Detrusitol retard Pharmaceutical Form: Capsule, hard INN or Proposed INN: TOLTERODINE CAS Number: 124937‐51‐5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2‐4 CONDITION: 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 Therapeutic area: Diseases [C] ‐ Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] PRIMARY OUTCOME: Main Objective: Efficiency and tolerance of fesoterodine in comparison with intravesical oxybutynin +/‐ tolterodine in children with neurogenic detrusor overactivity. Primary end point(s): maximum cystometric bladder capacity=; maximal tolerable cystometric capacity ; ‐ until voiding; ‐ until leaking; ‐ at 40 cmH2O; Secondary Objective: not applicable Timepoint(s) of evaluation of this end point: week 1 and 7, before and after admission of fesoterodine SECONDARY OUTCOME: 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? ; 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
Epistemonikos ID: 14cf94fac51c8a013a691174cbd26ff10775ad00
First added on: Jul 27, 2021