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Oxybutynin for Bladder Infection

Phase 4
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four hours after each of the three doses of study medication.
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four hours after each of the three doses of study medication.
This trial's timeline: 3 weeks for screening, Varies for treatment, and four hours after each of the three doses of study medication. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication.
Secondary study objectives
Measurements of pain/discomfort with each urination recorded during the first 24 hours.
Number of supplemental doses of acetominophen used during the first 24 hours of the study.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxybutyninExperimental Treatment2 Interventions
Children aged 4 - 6 years: Oxybutynin 2.5 mg (2.5ml) po TID Children aged 7 - 16 years: Oxybutynin 5 mg (5ml) po TID
Group II: PlaceboPlacebo Group2 Interventions
Orasweet liquid placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxybutynin
FDA approved
Antibiotics
2017
Completed Phase 4
~5180

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Who is running the clinical trial?

University of CalgaryLead Sponsor
805 Previous Clinical Trials
883,951 Total Patients Enrolled
~5 spots leftby Sep 2025
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