Research and Clinical Trials

Title  
BOTOX®
Brief Description  
This study is to investigate the safety and effectiveness of BOTOX® injections into the bladder of children that have accidental loss of urine due to overactive bladder. BOTOX (1 or more of the treatment groups) has an acceptable safety profile when injected into the detrusor of patients 12 to 17 years of age with OAB. BOTOX (1 or more treatment groups) improves the symptoms of OAB as measured by a reduction from baseline in daytime urinary incontinence episodes.
Who may be Eligible  
Inclusion: Male or female, aged =12 years to =17 years of age at the time of informed consent; 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 has not been adequately managed with 1 or more anticholinergic agents for the treatment of OAB; 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; Negative urine pregnancy test for females who are postmenarche. Exclusion: Patient has an uncontrolled systemic disease, previous or current diagnosis of malignancy; Patient has symptoms of OAB due to any known neurological reason (eg, spina bifida, spinal cord injury, or cerebral palsy); 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. Patient has a history or evidence of any pelvic or urological abnormalities; 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; Patient has unmanaged, unresolved bowel problems (eg, constipation, encopresis); Patient currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturnal enuresis or nocturia; Patient currently uses or plans to use an implantable or nonimplantable electrostimulation/neuromodulation device for treatment of OAB; Patient uses CIC or an indwelling catherer to manage their OAB; 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; Patient has been treated with intravesical capsaicin or resiniferatoxin within 12 months of screening; Patient has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis; Patient cannot withhold any antiplatelet,anticoagulant therapy, or other medications with anticoagulant effects for 3 days prior to randomization/day 1.
Specialty/Disorder  
Urinary Bladder
Start Date  
07/01/2016
IRB Number  
CHS1-14-510
Principal Investigator  
Kennelly, Michael
Contact Name  
Robbin

For More Information, Contact   Robbin  Clark , BS
Phone:  (704) 355-7466  Email:  robbin.clark@carolinashealthcare.org
Address:  1023 Edgehill Road
Charlotte, NC 28207
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