Study of AOBO-001 for Overactive Bladder With Urge Urinary Incontinence and Frequency

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the study product, AOBO-001, when taken by adults with symptoms of overactive bladder. AOBO-001, is experimental, which means that the U. S. Food and Drug Administration (FDA) has not yet approved it for use. AOBO-001 has been approved in China as a prescription drug product to treat bedwetting in children. AOBO-001 is also approved in Hong Kong as a dietary supplement to improve quality of life for people with urinary incontinence. AOBO-001 is a botanical (from a plant) product. It is prepared from the seeds of Xanthoceras sorbifolia bunge plant, which is a flowering tree grown in Northern China. Approximately 60 subjects who are 18 years of age and older are expected to participate in this study at up to 8 investigational sites. Each subject will complete 6 visits to the study site over a 14-week period. Subjects will consume 8 capsules of the assigned test product twice daily (that is, 16 capsules daily). Capsules will be taken with at least 6 ounces of water approximately 30 minutes before breakfast and 30 minutes before dinner. If a subject qualifies, he/she will be randomly (by chance) assigned to one of three study treatment groups. Subjects in one group will consume capsules containing a daily dose of 3.2 grams of AOBO-001; a second group will consume capsules containing a daily dose of 6.4 grams of AOBO-001; and a third group will consume capsules containing a placebo (no active ingredients). Subjects will have a 2 in 3 chance of being assigned to an active study treatment group. Neither the subject nor the study doctor will know to which study treatment group the subject has been assigned, but this information is available in case of a medical emergency. There will be a time during the study dosing schedule when all subjects will consume capsules containing a placebo (no active ingredients). Subjects will not be told when they are receiving the placebo.