NCT03877289

Efficacy of Oxybutynin in Paediatric Cystitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystitis

Interventions

Type	Name	Description
DRUG	Oxybutynin	Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.
OTHER	"Orasweet" Liquid Placebo	A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.
DRUG	Antibiotics	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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2019-03-15
• Last updated: 2022-12-12

Locations

1 site across 1 country: Canada