Efficacy of Oxybutynin in Paediatric Cystitis
Condition: Cystitis
MeSH terms: Cystitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of this study is to determine if the addition of the bladder antispasmotic
      oxybutynin to standard antimicrobial therapy in the treatment of childhood cystitis will
      decrease the associated pain and discomfort. A randomized, double blind, placebo-controlled
      clinical trial design will be used. The second goal of this study will be to describe the
      nature and duration of symptoms associated with uncomplicated cystitis in the paediatric age
      group. Finally, adverse side effects associated with short term use of oxybutynin will be
      monitored.
    

Detailed description: 
      Roughly half of children age 4 to 16 who are diagnosed with a UTI have cystitis. Adult
      sufferers of cystitis report terrible scorching with voiding, frequent sensation of the need
      to void with little results, and aching and pressure in the abdomen and genitals. The
      management of cystitis in adulthood often includes medication directed at easing pain and
      discomfort. Little research has been directed at documenting the true incidence of these
      unpleasant symptoms in paediatric cystitis and virtually no literature exists on the
      management of the associated pain and discomfort. This study will aim to describe the nature
      and duration of unpleasant symptoms suffered by children with cystitis and will investigate
      the efficacy of a possible therapy to ease their suffering.

      Hypothesis: The investigators feel that oxybutynin is the most suitable agent for the first
      trial of bladder antispasmodics in paediatric cystitis. The investigators reasoning is as
      follows:

        1. Previous adult studies have favored an anticholinergic agent (flavoxate) over the
           topical analgesic phenazopyridine in the symptomatic treatment of cystitis.

        2. Newer anticholinergic agents such as oxybutynin and tolterodine have been shown to be
           superior to older anticholinergic agents (such as flavoxate) in the treatment of many
           uncomfortable conditions of the bladder.

        3. Oxybutynin has been extensively studied in children for several non-infectious
           conditions of the bladder. The safety profile, expected side effects and dosage range
           have therefore been established for children.

        4. Oxybutynin is marketed in a palatable syrup. A placebo can easily be manufactured that
           is identical in taste, texture, smell, color, and volume.

      The study will be a randomized, double-blind, placebo controlled clinical trial of oxybutynin
      therapy for symptom control in paediatric cystitis. Toilet trained children aged 4 - 16 years
      who present to the Alberta Children's Hospital (ACH) emergency room and receive a diagnosis
      of cystitis are eligible to participate.
    

Intervention name(s): Oxybutynin; "Orasweet" Liquid Placebo; Antibiotics
Intervention type(s): Drug; Other; Drug
Intervention description(s): Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.; A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.; All patients in treatment and control arms were treated as a co-intervention with an oral antibioitic, the type of which was chosen by the child's attending physician.
Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile, Cefaloridine, Cefroxadine, Cefatrizine, Cefuroxime, Cefixime, amoxicillin/clavulanic acid (Clavulin), and Nitrofurantoin.
Intervention MeSH terms: Anti-Bacterial Agents; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: pediatrics; cystitis; UTI; oxybutynin