VOCARE Bladder System

Questions And Answers For People Who May Be Interested In Obtaining The VOCARE Bladder System

What is the VOCARE Bladder System?

The VOCARE Bladder System is a medical device which has been used by people with spinal cord injuries to empty their bladder (or urinate) on demand..

The VOCARE Bladder system includes surgically implanted internal components and an external control unit. Internally, a pacemaker-type receiver-stimulator is surgically implanted under the skin of the abdomen. The System sends electrical signals through electrodes to the nerves that lead to the bladder.

The user controls this implant with an external controller which is about the size of a stereo cassette player. This unit consists of internal circuitry and a small transmitter antenna that is used when bladder stimulation is needed. This External Controller can be stored and used as needed.

Who can use the VOCARE Bladder System?

Candidates for the System are individuals who have a clinically complete spinal cord injury with resulting paraplegia or quadriplegia.

What are the criteria for receiving the VOCARE Bladder System?

The following list includes some of the guidelines for the device

• Skeletally mature
• Clinically complete spinal cord lesion
• Neurologically stable
• Intact reflex bladder contractions.

How could the VOCARE Bladder System help me?

The VOCARE Bladder System is designed to allow the user to empty the bladder when appropriate and, after voiding the bladder, to have a low residual volume of urine.

How long does it take to get ready for surgery, have a system implanted, and be comfortable using the system?

It depends on you and your schedule. The preoperative testing takes two to three days, usually as an outpatient, over a period of several weeks. Typically, you will be discharged in four to five days after the surgery with a functioning device. Follow-up visits may be required for post-surgical check-ups, and adjustments to the external controller.

What happens during surgery?

You will have general anesthesia and will be asleep during the six to 12 hour procedure. You will typically have two incisions on your back and smaller incisions on your side and abdomen (approximately four in all). At the lower end of the spine, the surgeon will perform a posterior rhizotomy (the surgical cutting of spinal nerve roots to prevent reflex incontinence) and place flexible electrodes on the nerves that run to the bladder. The electrodes are connected by thin wiring to an implantable receiver-stimulator under the skin of the abdomen.

Is the surgery painful?

Any level of discomfort depends upon your level of sensation. You may feel some slight discomfort while your body heals from the surgery. You may have a headache for a few days due to the spinal surgery. Your doctor can prescribe pain medication if it is appropriate.

What happens right after surgery?

You will probably stay in bed for two to three days after the surgery or until you can sit up without any discomfort. The VOCARE Bladder System will then be tested and programmed by your doctor. You should be able to use the device for a few days before leaving the hospital. You may expect to be discharged four to five days after surgery barring any unforeseen complications.

How soon after the surgery can I start using the VOCARE Bladder System?

You should be able to use the VOCARE Bladder System about three to four days after the surgery. Your doctor will test and adjust the device (a two to three hour task) approximately three days after the surgery. You will be able to start using the implant after the initial tests and adjustments.

How much time will I have to spend in check-ups after the surgery?

During the first few weeks after surgery your doctor will keep in close touch with you as an outpatient to check that the device is working properly. Typically, you will see your doctor three months after surgery and annually thereafter.

What does the device feel like?

You may notice a slight sensation when you use the device. Stimulation may also cause movement of the muscles of the lower extremities when you use the VOCARE Bladder System.

Is the implant noticeable to others?

Generally not. The Implantable-Receiver-Stimulator is usually located to the abdomen below the ribs under the skin. In thin people, a slight lump might be noticeable. The implant is usually not noticeable to people with average to heavy builds

What precautions will I need to take with the VOCARE Bladder System?

The external components are manufactured with durable materials, however, they need to be protected from water and physical abuse.

Will the implant ever need to be replaced ?

The implanted components of the VOCARE Bladder System do not have batteries and have been designed to last for several years. Based on many years of field experience, the VOCARE Bladder System has proven to be very reliable.

What are the chances that my body will reject the implant?

Very minimal. The materials used in the VOCARE Bladder System are inert and are materials that have been successfully used in implants for many years.

What is the cost?

The cost of the surgery, hospitalization and device vary depending on where your surgery is performed. Each site will work closely with you and your medical insurance carrier to determine exactly what benefits will be provided. If insurance benefits are not available, the site will assist you to identify any alternative funding sources.

Is the VOCARE Bladder System right for me?

As with any surgery, there are many considerations involved. We encourage you to investigate the VOCARE Bladder System as well as alternative methods of treatment which may be suitable for you. Please discuss this with your physician, family members and caregivers.

What do I do next?

Learn as much as you can so that you are comfortable making a decision. Talk with family and friends, and with your doctor. You may find it helpful to talk with someone who has received the VOCARE Bladder System. Please ask your VOCARE site to help you get in touch with a recipient for a confidential conversation.

What is the background of this technology?

The VOCARE Bladder System is based on the Finetech-Brindley Bladder Controller originally developed in England with the support of the Medical Research Council of Great Britain. The initial testing of the device in the United States was conducted by researchers at Case Western Reserve University, the Cleveland Veterans Affairs Medical Center and the MetroHealth Medical Center in conjunction with the Cleveland FES Center. A clinical trial was conducted and sponsored by NeuroControl Corporation.

Financial support for the clinical study in the United States was provided by:

• Office of Research and Development, Rehabilitation Research and Development Service, Department of Veterans Affairs;
• National Center for Medical Rehabilitation Research, National Institute of Child Health and Human Development, national Institutes of Health; and
• Spinal Cord Research Foundation, Paralyzed Veterans of America.

ADDITIONAL INFORMATION

INDICATIONS FOR USE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• X-rays, diagnotstic ultrasound
• Therapeutic ultrasound, therapeutic diathermy, and microwave therapy
• Electrocautery
• Antibiotic prophylaxis
• Drug interactions
• Prior procedures or conditions
• Post-operative incontinence
• Bowel motility
• The rhizotomy procedure
• Spinal instability
• Studies have not been conducted
• Post-operatively
• Unintended Stimulation
• Keep it dry
• Avoid possible interference
• External Defibrillation
• When to turn VOCARE Bladder System off

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