Status:
COMPLETED
Efficacy of Oxybutynin in Paediatric Cystitis
Lead Sponsor:
University of Calgary
Conditions:
Cystitis
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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 associ...
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 ...
Eligibility Criteria
Inclusion
- Age 4 - 16 years
- Suspected diagnosis of cystitis based on a clean catch or catheter urinalysis (must have at least one of the three screening tests positive - leukocyte esterase, nitrites, or leukocytosis or bactiuria on microscopy)
- Intention to manage patient as an out-patient with oral antibiotics
- Parent must be available to assist younger children with the measurements for 24 hours and must be willing to receive follow-up calls daily until symptoms resolve
- Written informed consent (and assent when age-appropriate)
Exclusion
- Clinically suspected pyelonephritis (ED temperature \> 38.5, significant flank pain, vomiting \> 3 times/24 hours)
- Patient not toilet trained
- Patient with significant language delays (preventing use of the facial pain scale)
- Patient with sensory deficits at the sacral level
- Inability of the patient and parent to speak and understand English
- Known contraindication to Oxybutynin (hypersensitivity, glaucoma, bowel obstruction, megacolon, ulcerative colitis, myesthenia gravis, renal or hepatic disease, hyperthyroidism, heart disease, and obstructive uropathy)
- Patient on any medications during the preceding 8 hours that have analgesic or anticholinergic properties (acetominophen, and inhaled medications will be permitted)
- Patients who have been previously enrolled in the study
- Lack of a telephone in the home
- Known or suspected pregnancy or lactation in the patient
- Treating physician uses pyridium
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03877289
Start Date
October 1 2008
End Date
July 1 2014
Last Update
December 12 2022
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8