Autologous Neo-Bladder Construct in Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence

An Open Label Multi-center Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence

Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Subjects with non-neurogenic over-active bladder and urge predominant incontinence who are intolerant to medical therapy or have persistence of symptoms despite medical therapy and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Inclusion Criteria:

• History of non-neurogenic overactive bladder for at least 12 months prior to study entry
• Intolerance to medical therapy or persistence of symptoms despite medical therapy

Exclusion Criteria:

• Subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence
• Use of Botulinum Toxin A injections into the bladder within the previous 6 months
• Presence of a neuromodulator
• Using catheterization as a way to control incontinence
• History of bladder cancer