Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03877289
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2019-01-16
Brief Title:
Efficacy of Oxybutynin in Paediatric Cystitis
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Efficacy of Oxybutynin in Paediatric Cystitis
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Childrens Hospital ACH emergency room and receive a diagnosis of cystitis are eligible to participate
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 Childrens Hospital ACH emergency room and receive a diagnosis of cystitis are eligible to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None