Intravesical BCG: induction and maintenance

Operative visualisation

UrOops3D · UroRef · © Nity G

Operative steps

1. Who gets BCG High-risk non-muscle-invasive bladder cancer: high-grade Ta or T1 disease, carcinoma in situ, and selected intermediate-risk disease where recurrence has been frequent. The premise is a complete resection, with detrusor muscle in the specimen for anything high grade, and a re-resection at two to six weeks for T1 disease, for high-grade tumour without muscle in the specimen, and where the first resection was incomplete. BCG given after an inadequate resection treats nothing and delays the cystectomy that a man with unrecognised muscle invasion needs. The multidisciplinary meeting confirms the risk group and the plan, and the patient is told that this is a course of treatment lasting years, not a single dose.
2. Timing and the checks before every dose The first dose is given two to four weeks after resection, once the resection bed has healed; earlier risks systemic absorption through raw urothelium. Before every dose, induction or maintenance, the same questions: any visible haematuria, any symptoms of infection or a positive urine culture, any traumatic catheterisation in the last two weeks, any fever or illness since the last dose, and any new immunosuppression. A yes to any of them defers the dose by a week. The tuberculin test is not required, but active tuberculosis, immunosuppression and pregnancy are contraindications that are asked about at the start.
   where it bites: haematuria, infection or a traumatic catheter in the last fortnight means the dose is deferred; BCG into a bleeding urothelium is BCG into the blood.
3. Preparation The dose is reconstituted by pharmacy or in a designated area under the local protocol, never on the open ward, and delivered in a closed syringe or bag. The person giving it wears gloves, a gown and eye protection; BCG is a live organism and a spill is cleaned with the local disinfectant. The patient has restricted fluids for a few hours beforehand and stops diuretics on the morning, so that the dose is not diluted and can be held. The patient empties the bladder before the catheter goes in, the identity and the dose are checked against the prescription by two people, and the bladder is confirmed empty on the catheter before anything is instilled.
4. The catheter, passed atraumatically A 12 or 14 French catheter, plenty of lidocaine gel and time, the penis held up to straighten the bulbar curve and the patient breathing at the sphincter: the least traumatic catheterisation of the day. Any blood on the catheter or in the drained urine means the urothelium is open and the dose is deferred, however far the patient has travelled. The catheter is advanced to the hub and the residual drained completely, because BCG needs an empty bladder to reach the whole urothelium. A difficult catheter is not forced; the dose is deferred and the next attempt is with a coudé or under vision.
   where it bites: blood on the catheter is the one absolute rule: the dose is not given today.
5. Instillation The reconstituted dose, a full vial in about 50 ml of saline, is instilled slowly through the catheter by gravity or gentle syringe pressure into the empty bladder, followed by a small flush of saline so that none is left in the catheter. Then either the catheter is removed, which is usual and most comfortable, or it is clamped for the dwell and removed afterwards in a patient who cannot hold the dose. The syringe, the catheter and the gloves go into the clinical waste for live organisms. The patient is told the time and that nothing should be drunk until the dose has been voided.
6. Two hours, turning, then the toilet The dose is held for two hours, or as long as the patient can manage up to two hours, turning from side to side and front to back every fifteen minutes so that the whole urothelium is bathed. Then the patient voids, sitting down to avoid splashing, and for the next six hours after each void undiluted household bleach is poured into the toilet, left for fifteen minutes and flushed with the lid down. Hands and genitals are washed after voiding, fluids are increased to flush the bladder, and a condom is used for sex for a week. The patient goes home with the contact number and the fever rule written down.
7. The schedule Induction is six instillations at weekly intervals. Maintenance follows for the patient who tolerates induction: three weekly instillations at three months, six months and then every six months, for one year in intermediate-risk disease and for three years in high-risk disease, which is the schedule that has been shown to reduce progression as well as recurrence. Many patients do not complete three years because of toxicity, and a reduced schedule is a shared decision with the multidisciplinary team, particularly during BCG shortages when a priority pathway applies. Each dose is preceded by the same checks as the first.
8. Toxicity and the fever rule Cystitis with frequency, dysuria and haematuria for a day or two after each dose is expected and treated with fluids, analgesia and anticholinergics; if it lasts beyond a few days the next dose is deferred or reduced. A low fever under 38.5 for less than 48 hours is common and settles. The rule is a fever over 38.5, or any fever lasting beyond 48 hours, or rigors, malaise or a systemically unwell patient: that is systemic BCG until proved otherwise. It needs admission, cultures for bacteria and mycobacteria, a chest radiograph, and antituberculous treatment with isoniazid, rifampicin and ethambutol, with steroids for BCG sepsis, on the advice of infectious diseases. BCG is stopped permanently after sepsis.
   where it bites: fever over 38.5 or beyond 48 hours after a dose is systemic BCG until proved otherwise; not another course of ciprofloxacin.
9. Response and failure Cystoscopy at three months, after induction, with cytology, is the first assessment; carcinoma in situ is also judged with cytology and biopsy. Persistent or recurrent high-grade disease defines the failures: BCG-refractory disease with high-grade tumour at three months, BCG-relapsing disease with high-grade recurrence within six to twelve months of adequate treatment, and together these form BCG-unresponsive disease, for which more BCG does not work. The treatment is radical cystectomy, offered promptly because progression to muscle invasion during further intravesical treatment loses the window of cure. Bladder-sparing alternatives are for the unfit or unwilling within a trial or a specialist pathway. The note for every dose records the checks, the catheter, the dose and the tolerance.

Complications and immediate saves

Trigger each of these live in the Animation tab, then read the save: the first move, the escalation trigger, and the line that goes in the op note.

FRCS viva questions

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Evidence and guidance