CystitisPhase 4NCT03877289
Efficacy of Oxybutynin in Paediatric Cystitis
A Phase 4 study testing Oxybutynin and Antibiotics in people with Cystitis, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cystitis
- What is being tested?
- Oxybutynin and Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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:
- Previous adult studies have favored an anticholinergic agent (flavoxate) over the topical analgesic phenazopyridine in the symptomatic treatment of cystitis.
- Newer anticholinergic agents such as oxybutynin and tolterodine have been shown to be superior to older anticholinergic agents (such as flavoxate) in the treatment of many uncomfortable conditions of the bladder.
- Oxybutynin has been extensively studied in children for several non-infectious conditions of the bladder. The safety profile, expected side effects and dosage range have therefore been established for children.
- Oxybutynin is marketed in a palatable syrup. A placebo can easily be manufactured that is identical in taste, texture, smell, color, and volume.
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.
- Conditions
- Cystitis
- Being tested
- Oxybutynin, "Orasweet" Liquid Placebo, Antibiotics
- Keywords
- pediatrics, cystitis, UTI, oxybutynin
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.
"Orasweet" Liquid PlaceboOther
A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.
AntibioticsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oxybutynin; Drug: Antibiotics |
| Placebo | Placebo comparator | Orasweet liquid placebo Receives: Other: "Orasweet" Liquid Placebo; Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measurements will be made using the McGrath Facial Affective Scale and will be recorded by the participant or family member at home.
Measured: 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.
Measured: Immediate 24 hours after presenting to the ED.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study startOct 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W Johnson, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877289
- Sponsor's protocol ID
- OxyRCT1
- Status last verified
- Dec 2022
- First submitted
- 16 Jan 2019
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxybutynin in Paediatric Cystitis
- ClinicalTrials.gov ID
- NCT03877289
- Acronym / sponsor ID
- OxyRCT1
- Conditions
- Cystitis
- Keywords
- pediatrics, cystitis, UTI, oxybutynin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Previous adult studies have favored an anticholinergic agent (flavoxate) over the topical analgesic phenazopyridine in the symptomatic treatment of cystitis.
- Newer anticholinergic agents such as oxybutynin and tolterodine have been shown to be superior to older anticholinergic agents (such as flavoxate) in the treatment of many uncomfortable conditions of the bladder.
- Oxybutynin has been extensively studied in children for several non-infectious conditions of the bladder. The safety profile, expected side effects and dosage range have therefore been established for children.
- Oxybutynin is marketed in a palatable syrup. A placebo can easily be manufactured that is identical in taste, texture, smell, color, and volume.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin | Experimental | Drug: Oxybutynin, Drug: AntibioticsChildren aged 4 - 6 years: Oxybutynin 2.5 mg (2.5ml) po TID Children aged 7 - 16 years: Oxybutynin 5 mg (5ml) po TID |
| Placebo | Placebo comparator | Other: "Orasweet" Liquid Placebo, Drug: AntibioticsOrasweet liquid placebo |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxybutyninOxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects. | Drug | Oxybutynin |
| "Orasweet" Liquid PlaceboA formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell. | Other | Placebo |
| AntibioticsAll 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. | Drug | Oxybutynin, Placebo |
Primary outcome
Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication.
Time frame: Four 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.
2 secondary outcomes
Measurements of pain/discomfort with each urination recorded during the first 24 hours.
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.
Time frame: Immediate 24 hours after presenting to the ED.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxybutynin and Antibiotics in people with Cystitis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication. (time frame: Four hours after each of the three doses of study medication.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.