Augmentation Cystoplasty Using an Autologous Neo-Bladder

An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida

Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Inclusion Criteria:

• subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria:

• prior augment procedures
• recent urologic surgery
• requires concomitant urologic intervention