Comprehensive Urology

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Imaging Services

The daVinci System

Intravesical BCG Therapy

Definition

Intravesical = in the urinary bladder

BCG = agent instilled into the bladder to kill bladder cancer

Bacillus Calmette-Guerin (named after the bacterial type and the original investigativescientist) is a live tuberculosis bacteria that was originally used in the 1920s (and still today) asa vaccine to prevent tuberculosis. Vaccines are an antigen. An antigen is a protein introducedinto your body that you immune system views as foreign. In response to a foreign antigen, ahealthy immune system will produce antibodies (cells that fight foreign material such as infections). Antibodies have memory so that if that one is exposed to the same antigen again inthe future, the antibodies made previously will attack that antigen. This occurs because ofnormal "immune response." In other words, a person will have already made antibodies inresponse to the vaccine antigen; antibodies that now immediately attack following new antigenexposure. This is the basic principle behind all vaccines such as polio, measles, mumps,rubella, rabies, tetanus, etc.

Almost 20 years ago, BCG was first reported to have anti-tumor effects against TCC or transitional cell carcinoma (the most common type of cancer occurring in the bladder). WhenTCC is directly exposed to BCG, an immune response is stimulated, one that has the potentialto kill the cancer cells. In order to treat a patient, the BCG is placed directly into the bladderthrough a catheter. The BCG used is called a "live-attenuated strain." This means that thebacteria are live but greatly weakened so as to minimize the chance of causing TB in the treatedpatient. There are many theories as to why BCG works against TCC in the bladder. Althoughthe mechanism is not fully understood, it is known that the BCG activates a specific part of theimmune system called T-cells. These cells are important in fighting many types of infections and cancers.

BCG may be used for three different reasons in the bladder. While the intended outcome is notguaranteed, there is a lot of literature to support its use in an attempt to:

  1. kill remaining tumor cells that may still exist after the primary tumor has been surgically removed
  2. prevent new tumors from forming after all known tumor cells have been cleared from the bladder
  3. decrease the incidence of progression (advancement to a higher stage of cancer)

Preparation

There is no particular preparation for BCG therapy. If you are currently sick (i.e. a severecold or flu) or have gross hematuria (blood in the urine that you can actually see), you musttell your urologist as BCG will not be administered under those conditions.

It will also not be given if a bladder infection is present, or if you are on antibiotics for anyother reason (unless OK'd by your urologist).

Procedure

To review the basics of what we discussed in the office: The actual procedure typically takesjust a few minutes. The initial treatment of BCG is once a week for six consecutive weeks.Prophylactic treatment schedules for prevention of future tumor recurrences vary and you willbe given a very specific schedule if you are going to be enrolled in a "BCG maintenance" program.

You will lie down on your back on a table. Under sterile conditions, a small soft catheter willbe gently advanced into your urethra and into your bladder. All of the urine in your bladderwill be emptied. Once your bladder is empty, the BCG medicine will be slowly poured into thecatheter through a large syringe or funnel attached to the catheter. The medicine is allowed toslowly run into the catheter until it is all administered. The amount is small and is usually farless than the volume capacity of your bladder. The catheter is then slowly and gently removed.

It is important for you to hold the medicine in your bladder for two hours so that the medicinecan remain in contact with the inner tissue lining of the bladder for that amount of time. If youtypically have a problem holding urine for that long, you may want to limit fluid consumptionfor a few hours prior to the treatment. Certainly, caffeine beverages (coffee, sodas, tea, etc.)should be avoided that day prior to your appointment. These drinks will make you have tourinate more frequently.

Post Procedure

*It is important for you to understand the discard precautions for the first time you urinateafter the treatment each week. Both men and women must sit on the toilet to urinate so that the BCG medicine does not splash anywhere but in the water. The toilet is then immediatelyflushed. Afterward, bleach should be poured into the toilet and allowed to remain for a coupleof minutes while the sides of the toilet are gently cleaned. Do not put your hands in the waterto clean. The toilet is then flushed again.

You might have a little stinging in the urethra the first time you urinate. This is usually due tothe catheterization and is not a cause for concern. Each week, the stinging may last a bitlonger than the prior week. This is due to cystitis (inflammation of the bladder wall) and/orurethritis (inflammation of the urethra). Although the sensation can last for two or threeurinations after several weeks of treatment, it is rare for it to persist beyond the day of thetreatment. In 25% of patients, there may be a little blood in the urine with the first fewurinations after each treatment. It will typically resolve in one to two days. If the urine is notclear to the eye by the next week, the following treatment will be delayed. Perhaps 20% ofpatients may have minor flu-like symptoms the day of the treatment. They include fatigue,muscle aches, and maybe even a low grade fever. Again, these symptoms usually resolve in 24hours. If you feel feverish, you should take your temperature. Any temperatures equal to orabove 101 degrees should be immediately reported to your physician.

Expectations of Outcome

The urologic literature contains innumerable articles discussing the optimum use of BCG inbladder cancer. While we administer the medicine for a six week course initially, there areplenty of articles supporting extended regimens or repeat regimens at various intervals.

Overall, the data support the use of BCG in certain grades (aggressiveness of the cell type) and stages (degree of depth of invasion into the bladder wall) of bladder cancer. BCG has been shown to effectively eradicate residual tumor (small areas of cancer left behind after the"scraping" procedure), delay or prevent new tumors from growing, and in many studies, delayprogression (advancement of the tumor to a higher stage). In that regard, its benefits typically outweigh its potential side effects.

After your initial six week course, your urologist will discuss the pros and cons of maintenancetherapy or repeat courses.

Possible Complications of the Procedure

ALL procedures, regardless of complexity or time, can be associated with unforeseenproblems. They may be immediate or even quite delayed in presentation. While we havediscussed these and possibly others in your consultation, we would like you to have a list sothat you may ask questions if you are still concerned. Aside from anesthesia complications, itis important that every patient be made aware of all possible outcomes which may include, butare not limited to:

Urinary Tract Infection or Urosepsis (Bloodstream Infection): Even from a minor and sterile procedure, it is possible for you to get an infection with bacteria that typicallycause urinary tract infections (UTIs). It may be a simple bladder infection that presentswith symptoms of burning urination, urinary frequency and a strong urge to urinate.This will usually resolve with a few days of antibiotics. If the infection enters thebloodstream, you might feel very ill. This type of infection can present with bothurinary symptoms and any combination of the following: fevers, shaking chills,weakness or dizziness, nausea and vomiting. You may require a short hospitalization forintravenous antibiotics, fluids, and observation. This problem is more common indiabetics, patients on long-term steroids, or in patients with disorders of the immune system.

BCG sepsis is different. This is an infection that is not caused by the more commonbacteria that typically cause UTIs. This describes life-threatening infection due to theinstilled BCG agent itself, and it can occur in 1-3% of patients undergoing this type oftherapy. BCG infection requires immediate hospitalization and treatment with veryspecific antibiotic agents.

If you have high temperatures or any symptoms of severe illness (fevers, shakingchills, weakness or dizziness, nausea and vomiting, confusion) let your doctor knowimmediately and proceed to the nearest emergency room.

  • Blood or Blood Clots in the Urine: As previously mentioned, BCG can cause cystitis(inflammation in the bladder). Severe inflammatory changes in the bladder can result inhematuria (blood in the urine). In almost all instances, the urine clears on its own overthe next day or so. If severe, the blood can form clots and block the flow of urine.This is more common in men who may already have partially obstructing prostates. thetreatment may be placement of a catheter to drain the urine from the bladder and/orirrigating the clots out of the bladder.
  • Urinary Retention: Even in the absence of bleeding in men, the prostate can becomeinflamed secondary to delayed infection. As a result, the flow or urine can be blocked.In this instance, a catheter is placed and your doctor would discuss the next step.Patients at greater risk are those who already have difficulty urinating before theprocedure due to BPH (benign prostatic hyperplasia).
  • Urethral Strictures: Strictures are narrow, scarred tissue areas. Although uncommon,any patient who is catheterized often can develop scar tissue months or years later.Strictures are typically treated with minor, minimally invasive procedures.

We provide this literature for patients and family members. It is intended to be an educationalsupplement that highlights some of the important points of what we have previously discussedin the office. Alternative treatments, the purpose of the procedure/surgery, and the points inthis handout have been covered in our face-to-face consultation(s).

The information contained in this document is intended solely to inform and educate and should not be used as asubstitute for medical evaluation, advice, diagnosis or treatment by a physician or other healthcare professional.While Delta Medix endeavors to ensure the reliability of information, such information is subject to change asnew health information becomes available. Delta Medix cannot and does not guaranty the accuracy orcompleteness of the information contained in this document, and assumes no liability for its content or for anyerrors or omissions. Please call your doctor if you have any questions.

Delta Medix, P.C.