BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
- Conditions
- Overactive Bladderurinary incontinence10004994
- Registration Number
- NL-OMON42096
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* 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
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
-for mirabegron, at least 14 days prior;8. patient currently uses or plans to use an implantable or nonimplantable electrostimulation/ neuromodulation device for treatment of OAB. (If a nonimplantable device is used, it must be discontinued at least 7 days prior to the first screening procedure; if a device is implanted, it must be inactive for at least 4 weeks prior to the first screening procedure; neither should be used during the study.);9. patient plans to start using psychiatric medications or medications for attention deficit hyperactivity disorder during the study. If the patient is already using such medications they should be on a stable dose prior to randomization/day 1 and agree to remain on the same dose during the study if possible when medically indicated.;10. patient uses CIC or an indwelling catheter to manage their OAB;11. patient has had previous or current botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months of randomization/ day 1 for any other condition or use;12. patient has been treated with intravesical capsaicin or resiniferatoxin within 12 months of screening ;13. patient has a post-void residual (PVR) urine volume of > 40 mL at screening. The PVR measurement can be repeated once on the same day; the patient is to be excluded if the repeated measure is above 40 mL.;14. patient has a daytime (waking hours) total volume of urine voided > 3000 mL, collected over one daytime period during the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* number of daytime urinary incontinence episodes</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>* number of daytime micturition episodes<br /><br>* number of daytime urgency episodes<br /><br>* presence or absence of night time urinary incontinence<br /><br>* volume voided per micturition<br /><br><br /><br>Health Outcomes:<br /><br>* Pediatric Incontinence Questionnaire (PinQ)<br /><br>* modified Treatment Benefit Scale (TBS)<br /><br><br /><br>Safety:<br /><br>* adverse events<br /><br>* serious adverse events<br /><br>* physical examination<br /><br>* vital signs (heart rate, blood pressure, respiration rate, and body<br /><br>temperature)<br /><br>* urine dipstick reagent strip test<br /><br>* urinalysis (with urine culture/sensitivity, as applicable)<br /><br>* hematology and clinical chemistry<br /><br>* PVR urine<br /><br>* immunogenicity testing<br /><br>* kidney and bladder ultrasound<br /><br>* urine pregnancy test for females who are postmenarche<br /><br>* concomitant medications<br /><br>* concurrent procedures</p><br>