Population to be Studied. This study will recruit adult subjects with UI caused by NDO due to either SCI or MS, who have not been adequately managed with oral medication. In order to ensure a homogenous population of subjects with SCI and MS for efficacy and safety assessments, all subjects will be required to be routinely performing CIC to manage bladder function, prior to study entry. This is also expected to reduce the risk of urinary tract infection (UTI) due to impaired voiding following BTX-A treatment, which is observed in subjects not performing CIC. In addition to BTX-A bladder-naive subjects who have never previously received intradetrusor BTX-A for UI, the study will also enrol BTX-A bladder-non-naive subjects, who have previously received intradetrusor BTX-A for NDO. This will reflect real world usage and it has been demonstrated previously that treatment response does not vary significantly following retreatment in subjects treated with intradetrusor BTX-A for UI due to NDO [18]. In order to be eligible for entry into the study, more than 9 months must have elapsed since any previous intradetrusor BTX-A treatment administration.
Population to be Studied. It is planned that this study will enroll approximately 200 men and women between 18 and 70 years of age who have serologically active SLE with moderate disease activity on the basis of a standard assessment of disease activity, validated for use as a measure in clinical studies. To be considered for inclusion in this study, patients must have a positive test for antinuclear antibodies (XXX) and/or a positive test for anti-dsDNA Ab and a clinical SLEDAI-2K score of at least 6 points and may not have an “A” score on the BILAG-2004 scale. In addition, patients who are using or were previously using oral corticosteroids or antimalarials, methotrexate, leflunomide, mycophenolate mofetil (MMF), or azathioprine must meet certain dosage requirements regarding these drugs (see section 4.1).
