BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
- Conditions
- rinary Incontinence Due to Overactive BladderMedDRA version: 17.0Level: PTClassification code 10046543Term: Urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disorders
- Registration Number
- EUCTR2014-000464-17-IT
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
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
night)
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
11. patient is able to complete study requirements including completion of bladder diaries and HRQOL questionnaires (these can also be completed by the parent/legally authorized representative), and is likely to attend study visits in the opinion of the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range: 108
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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)
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 history or evidence of any pelvic or urological abnormalities (including clinically relevant kidney abnormality), bladder surgery or disease, 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 has received anticholinergics or any other medications or therapies to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures, or intravesical anticholinergic therapy within 4 weeks of the start of screening (note: anticholinergic use is not allowed throughout study participation)
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 have been taking them for at least 6 months 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 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 2-day bladder diary collection period prior to randomization/day 1
15. postmenarche female patients of childbearing potential who are pregnant, nurs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method