The bion device: a minimally invasive implantable ministimulator for pudendal nerve neuromodulation in patients with detrusor overactivity incontinence.

The results of the bion pilot studies indicate that a considerable reduction in the degree of detrusor overactivity incontinence can be obtained in severely refractory cases, including women who had failed sacral nerve neuromodulation. The described technique is well tolerated by the patients. It is minimally invasive and relatively simple. Clinical trials of the bion-r device involving larger numbers of patients are underway in the United States and Europe. A subchronic instead of the currently used acute screening test might increase the percentage of patients assessed as suitable candidates for implantation. There-fore, methods of performing a subchronic test of the pudendal nerve also are being investigated.