Urinary IncontinencePhase 3NCT01852045
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
A Phase 3 study testing OnabotulinumtoxinA in people with Urinary Incontinence, run by Allergan at 31 sites in 8 countries.
Trial summary
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- OnabotulinumtoxinA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 2 Jul 2013to 11 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Urinary incontinence due to neurogenic detrusor overactivity
- Regularly using clean intermittent catheterization to empty the bladder
Who cannot join
- Surgery of the spinal cord within 6 months
- Diagnosis of cerebral palsy
- Current or planned use of a baclofen pump
- Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
- Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
- Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States14 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
McKay Urology Carolinas Medical Center
Charlotte, North Carolina, 28207
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Health System
Durham, North Carolina, 27710
Riley Hospital for Children
Indianapolis, Indiana, 46032
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Oklahoma Childrens Hospital
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
William Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073
Washington University School of Medicine
St Louis, Missouri, 63110
Pediatric Urology Associates, PC
Tarrytown, New York, 10591
France4 sites
Hopital Pellegrin - Enfants
Bordeaux, 33076
CHU de Limoges - Hopital Mere et l'Enfant
Limoges, 87000
Hopital Trousseau
Paris, 75012
Necker Enfants Malades Hospital
Paris, 75015
Belgium3 sites
UZ Antwerpen
Antwerp, 2650
UZ Gent , Urology
Ghent, 9000
UZ Leuven
Leuven, 3000
Poland3 sites
Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
Gdansk, 80-803
Specjalistyczny Gabinet Lekarski
Poznan, 61-512
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-369
Canada2 sites
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Czechia2 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Fakultni nemocnice Olomouc
Olomouc, 77520
Italy2 sites
Seconda Università di Napoli
Caserta, 80138
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
Turkey (Türkiye)1 site
Ankara University Medical Faculty Cebeci Hospital
Ankara, 6100
About this study
Official title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
- Conditions
- Urinary Incontinence
- Being tested
- OnabotulinumtoxinA
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA 50 U | Experimental | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified. Receives: Biological: OnabotulinumtoxinA |
| OnabotulinumtoxinA 100 U | Experimental | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. Receives: Biological: OnabotulinumtoxinA |
| OnabotulinumtoxinA 200 U | Experimental | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. Receives: Biological: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Measured: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Secondary outcomes (10)
Number of Participants With Treatment Emergent Adverse Events (TEAE)
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
Measured: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Change From Baseline in Average Urine Volume at First Morning Catheterization
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Measured: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories (0, 1, 2 nights).
Measured: Baseline (Day -28 to Day -1), Week 6
Change From Baseline in Maximum Cystometric Capacity (MCC)
The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model.
Measured: Baseline (Day -28 to Day -1) to Week 6
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement.
Measured: Baseline (Day -28 to -1) and Week 6
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Measured: Baseline (Day-28 to Day-1) to Week 6
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Measured: Baseline (Day 1) to Week 6
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model.
Measured: Baseline (Day -28 to -1) to Week 6
Time to Participant Request for Retreatment
Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit.
Measured: 48 weeks
Time to Participant Qualification for Retreatment
In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study start2 Jul 2013
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margarita Furmanov, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852045
- Sponsor's protocol ID
- 191622-120
- Other IDs
- 2012-004877-26
- Status last verified
- Nov 2019
- First submitted
- 9 May 2013
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
- ClinicalTrials.gov ID
- NCT01852045
- Acronym / sponsor ID
- 191622-120
- Conditions
- Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA 50 U | Experimental | Biological: OnabotulinumtoxinAOnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified. |
| OnabotulinumtoxinA 100 U | Experimental | Biological: OnabotulinumtoxinAOnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. |
| OnabotulinumtoxinA 200 U | Experimental | Biological: OnabotulinumtoxinAOnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Urinary incontinence due to neurogenic detrusor overactivity
- Regularly using clean intermittent catheterization to empty the bladder
Key exclusion criteria (7 listed)
- Surgery of the spinal cord within 6 months
- Diagnosis of cerebral palsy
- Current or planned use of a baclofen pump
- Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
- Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
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 |
|---|---|---|
| OnabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AOnabotulinumtoxinA injected into the detrusor wall on Day 1. | Biological | OnabotulinumtoxinA 100 U, OnabotulinumtoxinA 200 U, OnabotulinumtoxinA 50 U |
Primary outcome
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
10 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Change From Baseline in Average Urine Volume at First Morning Catheterization
Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Percentage of Participants With Night Time Urinary Incontinence
Time frame: Baseline (Day -28 to Day -1), Week 6
Change From Baseline in Maximum Cystometric Capacity (MCC)
Time frame: Baseline (Day -28 to Day -1) to Week 6
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
Time frame: Baseline (Day -28 to -1) and Week 6
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
Time frame: Baseline (Day-28 to Day-1) to Week 6
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
Time frame: Baseline (Day 1) to Week 6
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
Time frame: Baseline (Day -28 to -1) to Week 6
Time to Participant Request for Retreatment
Time frame: 48 weeks
Time to Participant Qualification for Retreatment
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Margarita Furmanov study director
Allergan
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OnabotulinumtoxinA in people with Urinary Incontinence, run by Allergan at 31 sites in 8 countries.
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 2 inclusion and 7 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, France, Belgium, Poland, Canada and 3 more countries. 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. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes (time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6). 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 21 Nov 2019.