Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL
      and to compare their efficacy for overactive bladder syndrome in children.
    

Detailed description: 
      Overactive bladder (OAB) is a highly prevalent disorder in the pediatric population. This
      condition comprises many urinary symptoms, such as urgency, increased daytime frequency of
      micturition, urge incontinence and nocturia1, 2. These symptoms are especially troublesome
      for the pediatric patients and their family since it causes embarrassment and it limits
      everyday activities and impairs children's development. Furthermore, serious complications
      are seen if this condition is not treated properly, as urinary tract infection,
      vesico-ureteral reflux and dysfunctional voiding. Antimuscarinic agents are the current
      pharmacologic mainstay for OAB. Many side effects are reported with the clinical use of
      antimuscarinics. In the last years, Fesoterodine, a new antimuscarinic, has been developed
      for the treatment of OAB. Studies show significant improvement of clinical symptoms in adults
      with OAB and fewer side effects. The outcomes for the pediatric population remain unknown due
      to lack of studies. Antimuscarinic agents are the mainstay of the current treatment of OAB.
      Oxybutynin is the most widely antimuscarinic agent used in the pediatric population and is
      the only molecule approved by Health Canada for children with OAB. However, some patients
      have a suboptimal response to antimuscarinic and many experience side effects. Children with
      OAB therefore represent a disease population with a need for an alternative effective, safe
      and well-tolerated therapy to help manage the overactive detrusor, reducing or preventing
      incontinence. Fesoterodine is a new antimuscarinic drug available as a prolonged release (PR)
      tablet formulation, and is approved in Europe, Canada and the USA at doses of 4 mg and 8 mg
      once daily for the treatment of OAB in adults; it is not approved for use in the pediatric
      population. Before randomization, subjects will undergo 2 weeks of urotherapy. At the end of
      these 2 weeks, the inclusion and exclusion criteria will be reassessed and the subjects
      admissible for the study will be randomized for a 8 week-treatment period during which the
      urotherapy will be continued. Eligible subjects will be randomized to 8 weeks of single-blind
      treatment with Fesoterodine 4 mg Po Die or Oxybutynin XL 10 mg Po Die. At the end of the 8
      week-treatment period, subjects will stop their current therapy for one week. At week 9, both
      cohorts will do a cross over. The cohort on Fesoterodine will be on Oxybutynin XL and vice
      versa. After 4 weeks on any given medication, the possibility of up-titration will be
      assessed. On a telephone interview with the research nurse, patients and parents will be
      questioned on compliance, tolerability and efficacy. If the patient is taking the medication
      ≥80% of the time, does not have any significant side effects and still has significant OAB
      symptoms, the investigators will offer a dose increase (Fesoterodine 8mg or Oxybutynin XL
      20mg daily). If accepted, the medication will be provided with instructions to report any new
      side effects. Oxybutynin XL (Ditropan XL) is the extended release and once a day formulation
      of Oxybutynin (actual gold standard for OAB in children). By using this formulation with
      children who can swallow pills, the control group has the same once a day regimen as
      Fesoterodine (Toviaz), thus avoiding this possible bias. The bid or tid immediate release
      formulation is known to create more side effects and decreases the compliance (sometime hard
      to administer the afternoon dose to children at school).

      Subjects will complete a 3-day voiding diary prior to each medical visit to assess the
      efficacy of the single-blind treatment and urotherapy. Visits will be done on week -2, 0, 8
      and 17 (+/- 5 days)
    

Intervention name(s): Fesoterodine; Oxybutynin XL
Intervention type(s): Drug; Drug
Intervention description(s): Administer medication to patients with overactive bladder; Administer medication to patients with overactive bladder
Other intervention name(s): Toviaz; Ditropan XL
Intervention MeSH terms: Fesoterodine; Oxybutynin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment