NL-OMON42096
Completed
Phase 3
BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age - BOTOX®for Paediatric Urinary Incontinence
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Allergan Limited
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* male or female, aged \* 12 years to \* 17 years of age at the time of informed consent;\* 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;\* 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 night);\* 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;\* patient has not been adequately managed with 1 or more anticholinergic agents for the treatment of OAB in the opinion of the investigator, ie, all patients are incontinent despite anticholinergic therapy, experiencing intolerable side effects, or are unwilling to continue to take the medication for any reason;\* patient is willing and able to use clean intermittent catheterization (CIC) to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator;\* patient agrees to a minimum fluid intake of 1500 mL/m2 body surface area (BSA) per day, 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;\* negative urine pregnancy test for females who are postmenarche
Exclusion Criteria
- •1\. patient has an uncontrolled systemic disease, 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 urinary tract infections (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;5\. patient has predominance of stress incontinence, or \*giggle\* incontinence, or any condition other than OAB that in the investigator\*s opinion may account for the patient being incontinent;6\. patient has unmanaged, unresolved bowel problems (eg, constipation, encopresis);7\. patient currently uses or plans to use medications or therapies to treat symptons of OAB, including nocturnal enuresis or nocturia. Patients previously receiving these medications must have discontinued their use prior to the start of the first screening procedure as follows:
- •\-for desmopressin, at least one day prior
- •\-for anticholinergic therapy, at least 7 days prior
- •\-for intravesical anticholinergic therapy, at least 4 weeks prior
Outcomes
Primary Outcomes
Not specified
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