This is a multicenter study is to investigate the long-term safety and effectiveness of BOTOX® injections into the bladder of children that have accidental loss of urine due to neurogenic detrusor overactivity (NDO). Approximately 100 subjects will participate in this study. Patients have to have completed the Allergan Study 191622-120 and be qualified to be retreated.
This is a multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of BOTOX in patients with urinary incontinence due to neurogenic detrusor overactivity who are 8 to 17 years of age. Patients will be evaluated during a screening period for eligibility. Eligible patients will be randomized and receive treatment on day 1.Patients will have posttreatment follow-up clinic visits at weeks 2, 6, and 12. Thereafter, patients will have alternating telephone and clinic follow-up visits every 6 weeks until they exit the study. Patients exit the study once they qualify for retreatment, or at week 48 if the patient never qualifies for retreatment. Request for retreatment can occur at any scheduled clinic or telephone visit or between scheduled visits from week 12 onwards. If the patient qualifies for retreatment they will exit the study, so the visit at which the patient qualifies for retreatment will also become the exit visit..