Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

Urinary Incontinence Clinical Trial

Official title:

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852045
• Other study ID #: 191622-120
• Secondary ID: 2012-004877-26
• Status: Completed
• Phase: Phase 3
• Start date: July 2, 2013
• Est. completion date: October 11, 2018

Study information

• Verified date: November 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Urinary incontinence due to neurogenic detrusor overactivity

• Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Biological:
• OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Antwerpen
Belgium	UZ Gent , Urology	Gent
Belgium	UZ Leuven	Leuven
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Králové
Czechia	Fakultni nemocnice Olomouc	Olomouc
France	Hopital Pellegrin - Enfants	Bordeaux
France	CHU de Limoges - Hopital Mere et l'Enfant	Limoges
France	Hopital Trousseau	Paris
France	Necker Enfants Malades Hospital	Paris
Italy	Seconda Università di Napoli	Caserta
Italy	IRCCS Ospedale Pediatrico Bambino Gesu	Roma
Poland	Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed	Gdansk
Poland	Specjalistyczny Gabinet Lekarski	Poznan
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu	Wroclaw
Turkey	Ankara University Medical Faculty Cebeci Hospital	Ankara
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	McKay Urology Carolinas Medical Center	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University Health System	Durham	North Carolina
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Oklahoma Childrens Hospital	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	William Beaumont Hospital Research Institute	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Pediatric Urology Associates, PC	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Italy,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Secondary	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.	First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Secondary	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.	Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Secondary	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).	Baseline (Day -28 to Day -1), Week 6
Secondary	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.	Baseline (Day -28 to Day -1) to Week 6
Secondary	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.	Baseline (Day -28 to -1) and Week 6
Secondary	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.	Baseline (Day-28 to Day-1) to Week 6
Secondary	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.	Baseline (Day 1) to Week 6
Secondary	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.	Baseline (Day -28 to -1) to Week 6
Secondary	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.	48 weeks
Secondary	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.	48 weeks

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.