Intravesical treatment using BCG immunotherapy

A tumour is an abnormal growth of the body’s tissue cells and can be classified as benign (not cancer) or malignant (cancer). Benign tumours do not invade healthy tissue or spread around the body, they are not cancers. Malignant tumours have the ability to invade healthy tissue and to spread to other areas of the body.

The bladder is a hollow, muscular, balloon-like organ. It is in your lower pelvis and connected to your kidneys by two tubes called ureters. Urine passes down these tubes and is collected and stored in the bladder. Urine is passed out of the bladder through a tube like structure called the urethra.

Your Consultant Urologist has referred you for treatment of your superficial bladder cancer with BCG. Superficial bladder cancer affects the inner surface of the bladder only but has the ability to progress to more invasive disease. The aim of the treatment is to reduce the tendency for new tumours to develop in the future by instilling the BCG into the bladder.

While some side-effects can be unpleasant with BCG treatment, they are usually manageable and go away in the days following treatment. Others require specific treatment. Occasionally, it may not be possible for you to complete the course of treatment due to particular or severe side effects. Please talk to your nurse or doctor if you are worried about side-effects or feel they may prevent you from finishing the course.

Common (affecting more than one in 10 people) side effects:

• Urinary tract infection requiring postponement of the next dose of BCG.
• Some bladder discomfort and/or painful urination after treatment.
• Flu-like symptoms (chills, fever, headaches, muscle aches) which can persist for two to three days.
• Frequency and urgency of urination. This may persist for two to three days or sometimes longer. If these symptoms do not settle quickly, you should be tested for urinary infection. Urinary tract infection requires antibiotic treatment and postponement of the next dose of BCG.
• Blood in the urine.
• Debris in the urine.

Occasional (affecting between one in 10 and one in 50 people) side effects:

• Inflammatory reactions can develop in various parts of the body (including testes, liver, joints and the back of the eye). You should report symptoms that could be related to these complications immediately, as they may need treatment.
• Narrowing of the urethra (water pipe) following repeated use of a catheter.

Rare (affecting less than one in 50 people) side effects:

• Persistent or severe bladder pain after treatment.
• Generalised and potentially serious infection with the BCG bacteria requiring antibiotic treatment in hospital with powerful antibiotics. This is not TB and there is no risk of catching TB from the treatment.

Hospital-acquired infection:

• Colonisation with MRSA (0.9 to 1 per cent in 110 people).
• Clostridium difficile bowel infection (0.2 to 1 per cent in 500 people).
• MRSA bloodstream infection (0.08 to 1 per cent in 1250 people).

Following treatment, if you experience the following symptoms you must contact your doctor or seek emergency help immediately (if attending the Accident and Emergency department, please bring this information with you to aid in your treatment

• Any sign of an allergic reaction which includes difficulty in breathing, shortness of breath, wheezing, rash and/or swelling of the face.
• Any sign of a BCG infection which includes cough, high fever (temperature greater than 39.5 °C/

Your consultant has recommended BCG treatment because of your symptoms and investigation findings.

If you choose not to have this treatment your consultant will discuss any alternatives that may be suitable for your type of bladder cancer. However it is important to note that not having treatment could have serious consequences for your health.

You should not drink for four hours before coming for treatment. This is so you are able to hold the BCG more easily inside your bladder and also to keep its concentration at an acceptable level.

The influenza and COVID 19 vaccinations can occasionally cause mild flu-like symptoms, like those experienced with BCG treatment. As it is helpful to understand the cause of any symptoms you might have, we recommend that you do not have these vaccinations within 1 week of receiving BCG treatment.

Please advise your nurse or doctor of any medications you take regularly. Certain drugs, particularly immuno- suppressants and some antibiotics can affect how the treatment works. If you are on antibiotic treatment please contact us to check if you can have the treatment. Some antibiotics cause the BCG to be less effective and we would recommend you finish your course and wait at least a week before starting or carrying on BCG treatment.

Your clinical nurse specialist will discuss with you what will happen before, during and after your treatment, and you will be given the opportunity to ask any questions that you may have. This is part of the process of obtaining your informed consent to proceed. If you have already started some treatment your nurse will discuss with you how you have been feeling since the last dose and whether you have experienced any side-effects (see above). You will then be asked to empty your bladder.

For the treatment you will then be asked to lay flat on a couch. Some lubricating gel will be placed in your urethra (water pipe) and a fine plastic tube (called a catheter) will be passed through the urethra and into the bladder. Any remaining urine will be drained and the BCG will then be instilled through the catheter (this is a liquid solution of about 50 ml). The catheter will then be removed.

Most patients will be able to travel home whilst the BCG solution is being held in their bladder. They will then pass the solution down the toilet at home after the two hours are up.

When passing urine within the first six hours after you have been treated, you should flush the toilet and then flush again (double-flush). Men should sit down to pass urine on the first occasion after the instillation of treatment but may pass urine in the normal fashion (standing) thereafter.

You should drink plenty of fluids (two to three litres) for two-three days after the treatment. Avoiding caffeinated drinks (tea, coffee, and cola) which can irritate the bladder, to help to reduce any bladder symptoms.

Treatment regimens can vary slightly between hospitals but all follow established guidelines for treatment which are based on evidence from clinical trials. The course of treatment at UCLH is made up of two parts:

Induction regime:

• One dose of BCG, given every week for six weeks.
• Following this, a six week break with no treatment (to allow your bladder to recover).
• A cystoscopy (usually under general anaesthetic) is then performed to assess how well the treatment has worked. This will be planned during your treatment and you will receive an appointment letter in the post (please contact the team if you are concerned that you have not received your appointment).
• You will be seen in the general urology outpatient clinic around three weeks after your cystoscopy to discuss the results and ongoing plan.

Maintenance treatments:

• Following your initial cystoscopy, ongoing maintenance treatments may be advised.
• These are necessary when there is no tumour recurrence in order to maintain the benefit of the induction courses.
• Weekly instillations of BCG for between one and three weeks (depending on the side-effects experienced) every six months.
• We aim to begin the first maintenance course of treatment at six months from the very beginning of the induction course.
• Up to six maintenance courses can be given, which can take up to three years overall.
• Regular flexible cystoscopies (cystoscopy using local anaesthetic as an outpatient) every three to six months are needed to continue to inspect your bladder for any signs of cancer recurrence. If you are unsure when your flexible cystoscopy is due or you have not received an appointment letter, please contact the team.

The clinical nurse specialists are responsible for organising your treatment regime and administering the intravesical BCG immunotherapy in the outpatient clinic. They provide a point of contact for you for ongoing support throughout your treatment (see contact details).

A cystoscopy under general anaesthetic will require a short stay in hospital (usually as a day case, but sometimes with an overnight stay).

Macmillan Cancer Support www.macmillan.org.uk

Tel: 0808 808 0000 (Mon-Fri, 9am-8pm)

Action on Bladder Cancer (ABC-UK) www.actionbladdercanceruk.org

ABC is a UK based charity made up of healthcare professionals and patients who are dedicated purely to improving the lives of people with bladder cancer and raising awareness of the disease.

Fight Bladder Cancer www.fightbladdercancer.co.uk

Fight Bladder Cancer is a UK based bladder cancer charity founded and run by bladder cancer survivors and their families.

The British Association of Urological Nurses (BAUN) www.baun.co.uk

BAUN is a registered charity which aims to promote and maintain the highest standards in the practice and development of urological nursing and urological patient care.

The British Association of Urological Surgeons (BAUS) www.baus.org.uk