The Viscera Bladder Control Balloon is an investigational device intended to treat female stress urinary incontinence. The balloon is designed to reduce rapid increases in intravesical pressure through the placement of a compressible air-filled balloon inside the bladder. The balloon acts like a shock absorber to slow rapid changes in pressure and reduce leakage. Placement and removal is intended to be performed in an office setting. The following video presentation will include examination of the indwelling Viscera Bladder Control Balloon at 12 months, removal of the balloon, and the insertion of a new balloon per the SUCCESS clinical trial protocol. The SUCCESS clinical trial is a randomized multi-center controlled clinical trial aimed at assessing the safety and effectiveness of the Viscera Bladder Control Balloon system in women who have predominant stress urinary incontinence. At the start of the procedure, a single-use cystoscopic sheath is removed from the sterile packaging and placed onto the sterile field. Ten minutes prior to the procedure, the patient will be prepped with 10% lidocaine jelly injected into the urethra. Then, the protective sheath is placed into the patient's urethra, and the obturator is removed. A 30-degree rigid rod lens scope is advanced to examine the bladder and the balloon prior to removal. Once the bladder and the balloon have been examined, the camera and the light source are attached to an optical grasper. The grasper used for the removal of the indwelling balloon has been specially designed with 19-gauge needle tips welded inside the jaws of the grasper. This design allows the balloon to be punctured and for the air to escape the balloon prior to removing it through the sheath. Once the optical grasper has been assembled, the grasper is advanced through the sheath. Once the balloon has been located, it is captured by the grasper and punctured. As the deflated balloon is pulled through the sheath, it is pulled against the distal edge of the sheath, helping to evacuate any remaining air and protecting the patient's urethra as the deflated balloon and grasper are removed. After the balloon is removed, a new vascular bladder control delivery system is prepared for a new balloon insertion. The vascular bladder control delivery system consists of a sterile delivery catheter loaded with an uninflated balloon, a sterile pre-filled air syringe, and a sterile syringe of airlock. Note that the instructions for assembling the device are clearly marked on the delivery handle. Once the delivery device is assembled, it is passed to the physician and inserted through the sheath for balloon deployment. Steps for the deployment of the balloon occur in a similar order as the assembly instructions. 0.7 cc's of airlock is injected. Airlock is a proprietary biocompatible formulation of plefluorocarbon, which is used to keep the balloon inflated for up to 12 months. Next, 30 cc's of air is injected. The red safety lever is released, and the purple trigger is pulled to release the inflated balloon from the tip of the delivery catheter. And the delivery catheter is removed from the sheath. While maintaining the sheath inside the patient's urethra, a 30 degree scope is passed through the sheath to examine the new balloon to ensure it has properly inflated. At the conclusion of the final examination, the scope is removed followed by the disposable sheath. Most patients tolerate both the removal and placement of the balloon well. Patients citing discomfort voice similar comments regarding diagnostic cystoscopy. Patients are prescribed prophylactic antibiotics 24 hours prior to and 24 hours after the procedure. Enrollment into the success trial was completed in August of 2015. Data from this trial is pending submission to the FDA later this year.

Viscera Bladder Control Balloon

female stress urinary incontinence

compressible air-filled balloon

SUCCESS clinical trial

device's safety and effectiveness