Overactive BladderPhase 3FOXYNCT02327936
Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children
A Phase 3 study testing Fesoterodine and Oxybutynin XL in people with Overactive Bladder, run by Stéphane Bolduc.
Trial summary
The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL and to compare their efficacy for overactive bladder syndrome in children. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Fesoterodine and Oxybutynin XL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2018
- Phase
- Phase 3
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female ≥ 5 years old and ≤14 years old
- OAB diagnostic according to the International Children Continence Society (ICCS) and less than 65% of the expected mean bladder capacity for age is confirmed (30 + (age in years x 30) mL) on a 3-day voiding diary.
- Weight and height are within the normal percentile (3rd to 97th percentile) and weight is ≥ 20 kg (3rd percentile of a 8 y.o. child, boy or girl), according to the CDC growth chart
- Ability to swallow pills
- Subjects/parents (vs. legal guardian) agree to participate to the following study and sign the informed consent
- Subjects/parents (vs. legal guardian) are able to comply with the study requirements and with the medication restrictions.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. Sexually active male subjects agree to use a barrier method of birth control with female partner for the duration of the study and at least one month after ending study treatment. Sexually active male subjects agree to use a condom for the duration of the study and for at least one month after ending study treatment and the female partner to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment.
Who cannot join
- Subject has a diagnostic of dysfunctional voiding
- Post-voiding residue > 20 cc
- Polyuria (> 75 ml/kg/b.w./24 hours)
- Nephrogenic of central diabetes insipidus
- Constipation at screening (if the patient is treated and the treatment is successful, the patient will be eligible to the study)
- Urinary tract infection at visit 2-3-4. If UTI is present at the screening visit, the UTI must be treated and the success of the treatment must be documented with a negative urinalysis at visit 2.
Show all 15Show fewer
- QTc interval greater than 460 ms, or any increase of 30 ms on follow-up EKG (mean of 6 separate EKG-3 from visit week-2 and 3 from visit week 0). If a patient meets those criteria in the first month (initial dose), he will be excluded from the study. If the QTc change is noted after the up-titration, the dose will be decreased and EKG will be repeated within 1 week to ensure normalization of QTc.
- Clinically significant unstable medical condition or disorder
- Subject is pregnant or intends to become pregnant
- Serum creatinin more than or equal to 2 times the upper limit of normal
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN.
- Known hypersensitivity to Oxybutynin or Fesoterodine or any contraindication to the use of those 2 molecules, in accordance to the product monography (to the exception of pediatric age).
- Subject is taking medication that interact with Fesoterodine and this medication can't be discontinued (see appendix 1 of excluded drugs)
- Known urological pathology other than OAB that could explain urinary symptoms (as bladder stone…)
- Non-treated or non-controlled arterial hypertension
About this study
Official title: Efficacy and Tolerability of Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children: a Comparative Study.
The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL and to compare their efficacy for overactive bladder syndrome in children.
Read the detailed description
Overactive bladder (OAB) is a highly prevalent disorder in the pediatric population. This condition comprises many urinary symptoms, such as urgency, increased daytime frequency of micturition, urge incontinence and nocturia1, 2. These symptoms are especially troublesome for the pediatric patients and their family since it causes embarrassment and it limits everyday activities and impairs children's development. Furthermore, serious complications are seen if this condition is not treated properly, as urinary tract infection, vesico-ureteral reflux and dysfunctional voiding. Antimuscarinic agents are the current pharmacologic mainstay for OAB. Many side effects are reported with the clinical use of antimuscarinics. In the last years, Fesoterodine, a new antimuscarinic, has been developed for the treatment of OAB. Studies show significant improvement of clinical symptoms in adults with OAB and fewer side effects. The outcomes for the pediatric population remain unknown due to lack of studies. Antimuscarinic agents are the mainstay of the current treatment of OAB. Oxybutynin is the most widely antimuscarinic agent used in the pediatric population and is the only molecule approved by Health Canada for children with OAB. However, some patients have a suboptimal response to antimuscarinic and many experience side effects. Children with OAB therefore represent a disease population with a need for an alternative effective, safe and well-tolerated therapy to help manage the overactive detrusor, reducing or preventing incontinence. Fesoterodine is a new antimuscarinic drug available as a prolonged release (PR) tablet formulation, and is approved in Europe, Canada and the USA at doses of 4 mg and 8 mg once daily for the treatment of OAB in adults; it is not approved for use in the pediatric population. Before randomization, subjects will undergo 2 weeks of urotherapy. At the end of these 2 weeks, the inclusion and exclusion criteria will be reassessed and the subjects admissible for the study will be randomized for a 8 week-treatment period during which the urotherapy will be continued. Eligible subjects will be randomized to 8 weeks of single-blind treatment with Fesoterodine 4 mg Po Die or Oxybutynin XL 10 mg Po Die. At the end of the 8 week-treatment period, subjects will stop their current therapy for one week. At week 9, both cohorts will do a cross over. The cohort on Fesoterodine will be on Oxybutynin XL and vice versa. After 4 weeks on any given medication, the possibility of up-titration will be assessed. On a telephone interview with the research nurse, patients and parents will be questioned on compliance, tolerability and efficacy. If the patient is taking the medication ≥80% of the time, does not have any significant side effects and still has significant OAB symptoms, the investigators will offer a dose increase (Fesoterodine 8mg or Oxybutynin XL 20mg daily). If accepted, the medication will be provided with instructions to report any new side effects. Oxybutynin XL (Ditropan XL) is the extended release and once a day formulation of Oxybutynin (actual gold standard for OAB in children). By using this formulation with children who can swallow pills, the control group has the same once a day regimen as Fesoterodine (Toviaz), thus avoiding this possible bias. The bid or tid immediate release formulation is known to create more side effects and decreases the compliance (sometime hard to administer the afternoon dose to children at school).
Subjects will complete a 3-day voiding diary prior to each medical visit to assess the efficacy of the single-blind treatment and urotherapy. Visits will be done on week -2, 0, 8 and 17 (+/- 5 days)
- Conditions
- Overactive Bladder
- Being tested
- Fesoterodine, Oxybutynin XL
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Also called Toviaz
Administer medication to patients with overactive bladder
Oxybutynin XLDrug
Also called Ditropan XL
Administer medication to patients with overactive bladder
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine 4mg | Experimental | Fesoterodine 4 mg Po Die, dose could be increased to 8mg Po Die after 4 weeks, for a total of 8 weeks Receives: Drug: Fesoterodine |
| Oxybutynin XL 10mg | Active comparator | Oxybutynin XL 10 mg Po Die, dose could be increased to 20 mg Po Die after 4 weeks, for a total of 8 weeks Receives: Drug: Oxybutynin XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Fesoterodine and Oxybutynin XL
Side effects: the number of patients in each arm presenting side effects of grade 1, 2 and 3 (mild, moderate, severe).
Between study arms, for cardiovascular safety: mean difference in blood pressure, mean difference in heart rate, mean difference in QTcB.
- Vital signs (blood pressure and heart rate),
- Increase of more than 20% of heart rate at rest
- Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg
- Or symptoms suggesting it, without reaching those variations. o Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication.
Blood tests profile comparing number of subjects with significant changes: Blood work (including hepatic and renal workups, electrolytes, Hb-Ht).
Measured: 4 months
Secondary outcomes (2)
Number of Participants with Improved Overactive Bladder Symptoms as a Measure of Efficacy of Fesoterodine and Oxybutynin XL
Improved symptoms: Change from baseline to final voiding diary (after completion of each treatment on week 8 and week 17) in mean volume per micturition (first micturition of the day excluded).
Measured: 4 months
Number of urgency and urinary incontinence episodes as a Measure of Efficacy of Fesoterodine and Oxybutynin XL
- Mean number of daytime incontinence per 24 h.
- Mean number of nighttime incontinence per 24 h.
- Mean number of grade 2 and 3 urgency episodes (according to the CUA voiding diary; 0-3) per 24 h.
- Mean number of micturition per 24 h.
- Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6, at study initiation and every visit.
- Results will be documented based on subjective relief of symptoms and objective voiding diaries following the ICCS classification.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stéphane Bolduc
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Stéphane Bolduc, CHU de Quebec-Universite Laval
- Investigators
- Stéphane Bolduc, MD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327936
- Sponsor's protocol ID
- FOXY2014
- Acronym
- FOXY
- Status last verified
- Jul 2019
- First submitted
- 10 Dec 2014
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication to be submitted in peer reviewed journal, end of 2019
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children: a Comparative Study.
- ClinicalTrials.gov ID
- NCT02327936
- Acronym / sponsor ID
- FOXY / FOXY2014
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Stéphane BolducUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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 purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL and to compare their efficacy for overactive bladder syndrome in children.
Detailed description
Overactive bladder (OAB) is a highly prevalent disorder in the pediatric population. This condition comprises many urinary symptoms, such as urgency, increased daytime frequency of micturition, urge incontinence and nocturia1, 2. These symptoms are especially troublesome for the pediatric patients and their family since it causes embarrassment and it limits everyday activities and impairs children's development. Furthermore, serious complications are seen if this condition is not treated properly, as urinary tract infection, vesico-ureteral reflux and dysfunctional voiding. Antimuscarinic agents are the current pharmacologic mainstay for OAB. Many side effects are reported with the clinical use of antimuscarinics. In the last years, Fesoterodine, a new antimuscarinic, has been developed for the treatment of OAB. Studies show significant improvement of clinical symptoms in adults with OAB and fewer side effects. The outcomes for the pediatric population remain unknown due to lack of studies. Antimuscarinic agents are the mainstay of the current treatment of OAB. Oxybutynin is the most widely antimuscarinic agent used in the pediatric population and is the only molecule approved by Health Canada for children with OAB. However, some patients have a suboptimal response to antimuscarinic and many experience side effects. Children with OAB therefore represent a disease population with a need for an alternative effective, safe and well-tolerated therapy to help manage the overactive detrusor, reducing or preventing incontinence. Fesoterodine is a new antimuscarinic drug available as a prolonged release (PR) tablet formulation, and is approved in Europe, Canada and the USA at doses of 4 mg and 8 mg once daily for the treatment of OAB in adults; it is not approved for use in the pediatric population. Before randomization, subjects will undergo 2 weeks of urotherapy. At the end of these 2 weeks, the inclusion and exclusion criteria will be reassessed and the subjects admissible for the study will be randomized for a 8 week-treatment period during which the urotherapy will be continued. Eligible subjects will be randomized to 8 weeks of single-blind treatment with Fesoterodine 4 mg Po Die or Oxybutynin XL 10 mg Po Die. At the end of the 8 week-treatment period, subjects will stop their current therapy for one week. At week 9, both cohorts will do a cross over. The cohort on Fesoterodine will be on Oxybutynin XL and vice versa. After 4 weeks on any given medication, the possibility of up-titration will be assessed. On a telephone interview with the research nurse, patients and parents will be questioned on compliance, tolerability and efficacy. If the patient is taking the medication ≥80% of the time, does not have any significant side effects and still has significant OAB symptoms, the investigators will offer a dose increase (Fesoterodine 8mg or Oxybutynin XL 20mg daily). If accepted, the medication will be provided with instructions to report any new side effects. Oxybutynin XL (Ditropan XL) is the extended release and once a day formulation of Oxybutynin (actual gold standard for OAB in children). By using this formulation with children who can swallow pills, the control group has the same once a day regimen as Fesoterodine (Toviaz), thus avoiding this possible bias. The bid or tid immediate release formulation is known to create more side effects and decreases the compliance (sometime hard to administer the afternoon dose to children at school).
Subjects will complete a 3-day voiding diary prior to each medical visit to assess the efficacy of the single-blind treatment and urotherapy. Visits will be done on week -2, 0, 8 and 17 (+/- 5 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fesoterodine 4mg | Experimental | Drug: FesoterodineFesoterodine 4 mg Po Die, dose could be increased to 8mg Po Die after 4 weeks, for a total of 8 weeks |
| Oxybutynin XL 10mg | Active comparator | Drug: Oxybutynin XLOxybutynin XL 10 mg Po Die, dose could be increased to 20 mg Po Die after 4 weeks, for a total of 8 weeks |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female ≥ 5 years old and ≤14 years old
- OAB diagnostic according to the International Children Continence Society (ICCS) and less than 65% of the expected mean bladder capacity for age is confirmed (30 + (age in years x 30) mL) on a 3-day voiding diary.
- Weight and height are within the normal percentile (3rd to 97th percentile) and weight is ≥ 20 kg (3rd percentile of a 8 y.o. child, boy or girl), according to the CDC growth chart
- Ability to swallow pills
- Subjects/parents (vs. legal guardian) agree to participate to the following study and sign the informed consent
Key exclusion criteria (15 listed)
- Subject has a diagnostic of dysfunctional voiding
- Post-voiding residue > 20 cc
- Polyuria (> 75 ml/kg/b.w./24 hours)
- Nephrogenic of central diabetes insipidus
- Constipation at screening (if the patient is treated and the treatment is successful, the patient will be eligible to the study)
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 |
|---|---|---|
| FesoterodineAlso: ToviazAdminister medication to patients with overactive bladder | Drug | Fesoterodine 4mg |
| Oxybutynin XLAlso: Ditropan XLAdminister medication to patients with overactive bladder | Drug | Oxybutynin XL 10mg |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Fesoterodine and Oxybutynin XL
Time frame: 4 months
Side effects: the number of patients in each arm presenting side effects of grade 1, 2 and 3 (mild, moderate, severe). Between study arms, for cardiovascular safety: mean difference in blood pressure, mean difference in heart rate, mean difference in QTcB. * Vital signs (blood pressure and heart rate), * Increase of more than 20% of heart rate at rest * Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg * Or symptoms suggesting it, without reaching those variations. o Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication. Blood tests profile comparing number of subjects with significant changes: Blood work (including hepatic and renal workups, electrolytes, Hb-Ht).
2 secondary outcomes
Number of Participants with Improved Overactive Bladder Symptoms as a Measure of Efficacy of Fesoterodine and Oxybutynin XL
Time frame: 4 months
Number of urgency and urinary incontinence episodes as a Measure of Efficacy of Fesoterodine and Oxybutynin XL
Time frame: 4 months
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 30 Jul 2019.
- Individual participant dataSharing planned: Yes. Publication to be submitted in peer reviewed journal, end of 2019
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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.
Stéphane Bolduc, MD principal investigator
CHU de Québec-Université Laval
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fesoterodine and Oxybutynin XL in people with Overactive Bladder, run by Stéphane Bolduc.
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 7 inclusion and 15 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Fesoterodine and Oxybutynin XL (time frame: 4 months). 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 30 Jul 2019.