BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

Allergan Limited0 sites108 target enrollmentJune 23, 2015

Conditionsrinary Incontinence Due to Overactive Bladder MedDRA version: 18.0Level: PTClassification code 10046543Term: Urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disorders Therapeutic area: Not possible to specify

DrugsBOTOX®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: rinary Incontinence Due to Overactive Bladder
Sponsor: Allergan Limited
Enrollment: 108
Status: Active, Not Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 23, 2015

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergan Limited

Eligibility Criteria

Inclusion Criteria

•1\. written informed consent has been obtained from the legally authorized representative and written minor assent has been obtained, in accordance with local laws and institutional review board (IRB)/independent ethics committee (IEC) requirements
•2\. written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information (US sites) and written Data Protection consent (European sites)
•3\. male or female, aged \= 12 years to \= 17 years of age at the time of informed consent
•4\. patient has symptoms of OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by patient history
•5\. patient experiences a total of \= 2 episodes of daytime urinary urgency incontinence in the 2\-day patient bladder diary completed during the screening period (daytime is defined as time between waking up to start the day and going to bed to sleep for the
•6\. patient experiences urinary frequency, defined as an average of \= 8 micturitions (toilet voids) per day ie, a total of \= 16 micturitions in the 2\-day patient bladder diary completed during the screening period
•7\. patient has not been adequately managed with 1 or more anticholinergic agents for the treatment of OAB in the opinion of the investigator. This includes patients who are still incontinent despite anticholinergic therapy, experiencing intolerable side effects, or are unwilling to continue to take the medication for any reason.
•8\. patient is willing and able to use CIC to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator
•9\. patient agrees to a minimum fluid intake of 1500 mL/m2 BSA, not to exceed 3000 mL/m2 BSA per day, during the patient bladder diary completion days at screening and prior to clinic visits during the study
•10\. negative urine pregnancy test for females who are postmenarche

Exclusion Criteria

•1\. patient has an uncontrolled systemic disease, or has previous or current diagnosis of malignancy
•2\. patient has symptoms of OAB due to any known neurological reason (eg, spina bifida, spinal cord injury, or cerebral palsy)
•3\. patient has a history of 2 or more UTIs treated with antibiotics within 6 months of randomization/day 1 or is taking prophylactic antibiotics to prevent chronic UTI
•4\. patient has a history or evidence of any pelvic or urological abnormalities, except OAB, including:
•o bladder neck surgery resulting in an open bladder neck, or reconstructive surgery of the lower urinary tract (eg, urostomy, urinary diversion, or bladder augmentation)
•o anatomical evidence of bladder outlet obstruction (including functional outlet obstruction), urethral or urethral valve obstruction/stricture at screening
•o surgery of the urinary tract (including minimally invasive surgery) within 6 months of screening (except those listed above which are exclusionary for any time period)
•o circumcision within 1 month of screening
•o clinically relevant kidney abnormality, or clinically relevant vesicoureteric reflux, or disease of the bladder (other than OAB) that
•may affect bladder function