DEVICE: RED (B960RED201)

Device Description: The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted into the rectum. RED is used to evaluate the neuromuscular function of the patient's ability to expel its content from the rectum and a qualitative test for rectal hypersensitivity. It is intended to be used in a clinical setting by providers in adult populations. RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume the foam displaces when inflated with room air is 52 - 60 ml. This passive expansion provides the same function as filling an empty balloon with water or air, but the proprietary foam behaves and feels like normal stool. When expanded, the volume of material inside the patient’s rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate at lower volumes. This is measured by asking patients a few questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually. Cartons may have 1-5 devices as needed.