A Phase 4 interventional study of Oxybutynin and "Orasweet" Liquid Placebo in Cystitis, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-12-12.
Sponsored by University of Calgary · Phase 4, Interventional, and Supportive care
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.
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:
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children aged 4 - 6 years: Oxybutynin 2.5 mg (2.5ml) po TID Children aged 7 - 16 years: Oxybutynin 5 mg (5ml) po TID
Drug: Oxybutynin · Drug: Antibiotics
Orasweet liquid placebo
Other: "Orasweet" Liquid Placebo · Drug: Antibiotics
Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.
A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.
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.
Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication.
Participants will be asked to rate how they feel at each of these times using the McGrath Facial Affective Scale (MFAS). The MFAS ranges from the lowest pain score A (happy face) to the highest pain score I (very unhappy crying face). Data will be acquired over a 4 hours after the oxybutynin is given, therefore the investigators can expect that some of the measurements will be disrupted by nighttime sleep for some of the participants. Parents will be asked to document if their child is sleeping during the time when measurements are to be made.
Time frame: Four hours after each of the three doses of study medication.
Measurements of pain/discomfort with each urination recorded during the first 24 hours.
Measurements will be made using the McGrath Facial Affective Scale and will be recorded by the participant or family member at home.
Time frame: Immediate 24 hours after presenting to the ED.
Number of supplemental doses of acetominophen used during the first 24 hours of the study.
This information will be recorded by the participant or caregiver at home.
Time frame: Immediate 24 hours after presenting to the ED.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University of Calgary