ABOUT THIS STUDY
- Male or female ≥ 5 years old and ≤14 years old, and that completed the initial randomized study (Foxy2014).
- OAB diagnostic according to the International Children Continence Society (ICCS) and less than 65% of the expected mean bladder capacity for age is confirmed (30 + (age in years x 30) mL) on a 3-day voiding diary.
- Weight and height are within the normal percentile (3rd to 97th percentile) and weight is ≥ 20 kg (3rd percentile of a 8 y.o. child, boy or girl), according to the CDC growth chart
- Ability to swallow pills
- Subjects/parents (vs. legal guardian) agree to participate to the following study and sign the informed consent
- Subjects/parents (vs. legal guardian) are able to comply with the study requirements and with the medication restrictions.
Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. Sexually active male subjects agree to use a barrier method of birth control with female partner for the duration of the study and at least one month after ending study treatment. Sexually active male subjects agree to use a condom for the duration of the study and for at least one month after ending study treatment and the female partner to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment.
- Subject has a diagnostic of dysfunctional voiding
- Post-voiding residue > 20 cc
- Polyuria (> 75 ml/kg/b.w./24 hours)
- Nephrogenic of central diabetes insipidus
- Constipation at screening (if the patient is treated and the treatment is successful,
the patient will be eligible to the study)
- Urinary tract infection at visit 2-3-4. If UTI is present at the screening visit, the
UTI must be treated and the success of the treatment must be documented with a
negative urinalysis at visit 2.
- QTc interval greater than 460 ms, or any increase of 30 ms on follow-up EKG (mean of 6
separate EKG-3 from visit week-2 and 3 from visit week 0). If a patient meets those
criteria in the first month (initial dose), he will be excluded from the study. If the
QTc change is noted after the up-titration, the dose will be decreased and EKG will be
repeated within 1 week to ensure normalization of QTc.
- Clinically significant unstable medical condition or disorder
- Subject is pregnant or intends to become pregnant
- Serum creatinin more than or equal to 2 times the upper limit of normal
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal
to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN.
- Known hypersensitivity to Oxybutynin or Fesoterodine or any contraindication to the
use of those 2 molecules, in accordance to the product monography (to the exception of
- Subject is taking medication that interact with Fesoterodine and this medication can't
be discontinued (see appendix 1 of excluded drugs)
- Known urological pathology other than OAB that could explain urinary symptoms (as
- Non-treated or non-controlled arterial hypertension
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