Efficacy of Oxybutynin in Paediatric Cystitis

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Anti-Bacterial Agents; Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

1. Age 4 - 16 years

2. 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)

3. Intention to manage patient as an out-patient with oral antibiotics

4. 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

5. Written informed consent (and assent when age-appropriate)

Exclusion Criteria:

1. Clinically suspected pyelonephritis (ED temperature > 38.5, significant flank pain, vomiting > 3 times/24 hours)

2. Patient not toilet trained

3. Patient with significant language delays (preventing use of the facial pain scale)

4. Patient with sensory deficits at the sacral level

5. Inability of the patient and parent to speak and understand English

6. Known contraindication to Oxybutynin (hypersensitivity, glaucoma, bowel obstruction, megacolon, ulcerative colitis, myesthenia gravis, renal or hepatic disease, hyperthyroidism, heart disease, and obstructive uropathy)

7. Patient on any medications during the preceding 8 hours that have analgesic or anticholinergic properties (acetominophen, and inhaled medications will be permitted)

8. Patients who have been previously enrolled in the study

9. Lack of a telephone in the home

10. Known or suspected pregnancy or lactation in the patient

11. Treating physician uses pyridium