Efficacy of Oxybutynin in Paediatric Cystitis

NCT03877289 | Completed Phase 4

• 1 other identifier: OxyRCT1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis

Keywords

pediatrics; cystitis; UTI; oxybutynin

Outcome Measures

Primary Outcomes (1)

• 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.

  Four hours after each of the three doses of study medication.

Secondary Outcomes (2)

• Measurements of pain/discomfort with each urination recorded during the first 24 hours.

  Immediate 24 hours after presenting to the ED.

• Number of supplemental doses of acetominophen used during the first 24 hours of the study.

  Immediate 24 hours after presenting to the ED.

Study Arms (2)

Oxybutynin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Orasweet liquid placebo

Other: "Orasweet" Liquid Placebo; Drug: Antibiotics

Interventions

Oxybutynin DRUG

Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.

Oxybutynin

"Orasweet" Liquid Placebo OTHER

A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.

Placebo

Antibiotics DRUG

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.

Oxybutynin; Placebo

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Cystitis

Interventions

oxybutynin; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: March 15, 2019
• Study Start: October 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)