The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.
People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.
Follow the recommendations on communication and patient‑centred care in NICE's guideline on patient experience in adult NHS services and the advice in NICE's guidelines on improving outcomes in urological cancers and improving supportive and palliative care for adults with cancer throughout the person's care.
Offer clinical nurse specialist support to people with bladder cancer and give them the clinical nurse specialist's contact details.
Ensure that the clinical nurse specialist:
acts as the key worker to address the person's information and care needs
has experience and training in bladder cancer care.
Use a holistic needs assessment to identify an individualised package of information and support for people with bladder cancer and, if they wish, their partners, families or carers, at key points in their care such as:
when they are first diagnosed
after they have had their first treatment
if their bladder cancer recurs or progresses
if their treatment is changed
if palliative or end of life care is being discussed.
When carrying out a holistic needs assessment, recognise that many of the symptoms, investigations and treatments for bladder cancer affect the urogenital organs and may be distressing and intrusive. Discuss with the person:
the type, stage and grade of their cancer and likely prognosis
treatment and follow‑up options
the potential complications of intrusive procedures, including urinary retention, urinary infection, pain, bleeding or need for a catheter
the impact of treatment on their sexual health and body image, including how to find support and information relevant to their gender
diet and lifestyle, including physical activity
smoking cessation for people who smoke
how to find information about bladder cancer, for example through information prescriptions, sources of written information, websites or DVDs
how to find support groups and survivorship programmes
how to find information about returning to work after treatment for cancer
how to find information about financial support (such as free prescriptions and industrial compensation schemes).
Offer smoking cessation support to all people with bladder cancer who smoke, in line with NICE's guideline on tobacco: preventing uptake, promoting quitting and treating dependence.
Offer people with bladder cancer and, if they wish, their partners, families or carers, opportunities to have discussions at any stage during their treatment and care with:
a range of specialist healthcare professionals, including those who can provide psychological support
other people with bladder cancer who have had similar treatments.
Clinicians caring for people with bladder cancer should ensure that there is close liaison between secondary and primary care with respect to ongoing and community‑based support.
Trusts should consider conducting annual bladder cancer patient satisfaction surveys developed by their urology multidisciplinary team and people with bladder cancer, and use the results to guide a programme of quality improvement.
Do not substitute urinary biomarkers for cystoscopy to investigate suspected bladder cancer or for follow‑up after treatment for bladder cancer, except in the context of a clinical research study.
Consider CT or MRI staging before transurethral resection of bladder tumour (TURBT) if muscle‑invasive bladder cancer is suspected at cystoscopy.
Offer white‑light‑guided TURBT with one of photodynamic diagnosis, narrow‑band imaging, cytology or a urinary biomarker test (such as UroVysion using fluorescence in‑situ hybridization [FISH], ImmunoCyt or a nuclear matrix protein 22 [NMP22] test) to people with suspected bladder cancer. This should be carried out or supervised by a urologist experienced in TURBT.
Obtain detrusor muscle during TURBT.
Do not take random biopsies of normal‑looking urothelium during TURBT unless there is a specific clinical indication (for example, investigation of positive cytology not otherwise explained).
Record the size and number of tumours during TURBT.
Offer people with suspected bladder cancer a single dose of intravesical mitomycin C given at the same time as the first TURBT.
Consider further TURBT within 6 weeks if the first specimen does not include detrusor muscle.
Offer CT or MRI staging to people diagnosed with muscle‑invasive bladder cancer or high-risk non-muscle-invasive bladder cancer (see the section on risk classification in non-muscle-invasive bladder cancer) that is being assessed for radical treatment.
Consider CT urography, carried out with other planned CT imaging if possible, to detect upper tract involvement in people with new or recurrent high‑risk non‑muscle‑invasive or muscle‑invasive bladder cancer.
Consider CT of the thorax, carried out with other planned CT imaging if possible, to detect thoracic malignancy in people with muscle‑invasive bladder cancer.
Consider fluorodeoxyglucose positron emission tomography (FDG PET)‑CT for people with muscle‑invasive bladder cancer or high‑risk non‑muscle‑invasive bladder cancer before radical treatment if there are indeterminate findings on CT or MRI, or a high risk of metastatic disease (for example, T3b disease).
There is no widely accepted classification of risk in non‑muscle‑invasive bladder cancer. To make clear recommendations for management, the Guideline Development Group developed the consensus classification in table 1, based on the evidence reviewed and clinical opinion.
| Low risk |
Urothelial cancer with any of:
|
|---|---|
| Intermediate risk |
Urothelial cancer that is not low risk or high risk, including:
|
| High risk |
Urothelial cancer with any of:
|
Ensure that for people with non‑muscle‑invasive bladder cancer all of the following are recorded and used to guide discussions, both within multidisciplinary team meetings and with the person, about prognosis and treatment options:
recurrence history
size and number of cancers
histological type, grade, stage and presence (or absence) of flat urothelium, detrusor muscle (muscularis propria), and carcinoma in situ
the risk category of the person's cancer
predicted risk of recurrence and progression, estimated using a risk prediction tool.
For the treatment of low‑risk non‑muscle‑invasive bladder cancer, see recommendations 1.2.3 to 1.2.8.
Offer people with newly diagnosed intermediate‑risk non‑muscle‑invasive bladder cancer a course of at least 6 doses of intravesical mitomycin C.
If intermediate‑risk non‑muscle‑invasive bladder cancer recurs after a course of intravesical mitomycin C, refer the person's care to a specialist urology multidisciplinary team.
If the first TURBT shows high‑risk non‑muscle‑invasive bladder cancer, offer another TURBT as soon as possible and no later than 6 weeks after the first resection.
Offer the choice of intravesical BCG (Bacille Calmette‑Guérin) or radical cystectomy to people with high‑risk non‑muscle‑invasive bladder cancer, and base the choice on a full discussion with the person, the clinical nurse specialist and a urologist who performs both intravesical BCG and radical cystectomy. Include in your discussion:
the type, stage and grade of the cancer, the presence of carcinoma in situ, the presence of variant pathology, prostatic urethral or bladder neck status and the number of tumours
risk of progression to muscle invasion, metastases and death
risk of understaging
benefits of both treatments, including survival rates and the likelihood of further treatment
risks of both treatments
factors that affect outcomes (for example, comorbidities and life expectancy)
impact on quality of life, body image, and sexual and urinary function.
Offer induction and maintenance intravesical BCG to people having treatment with intravesical BCG.
If induction BCG fails (because it is not tolerated, or bladder cancer persists or recurs after treatment with BCG), refer the person's care to a specialist urology multidisciplinary team.
For people in whom induction BCG has failed, the specialist urology multidisciplinary team should assess the suitability of radical cystectomy, or further intravesical therapy if radical cystectomy is unsuitable or declined by the person, or if the bladder cancer that recurs is intermediate‑ or low‑risk.
Consider fulguration without biopsy for people with recurrent non‑muscle‑invasive bladder cancer if they have all of the following:
no previous bladder cancer that was intermediate‑ or high‑risk
a disease‑free interval of at least 6 months
solitary papillary recurrence
a tumour diameter of 3 mm or less.
Do not offer primary prophylaxis to prevent BCG‑related bladder toxicity except as part of a clinical trial.
Seek advice from a specialist urology multidisciplinary team if symptoms of bladder toxicity after BCG cannot be controlled with antispasmodics or non‑opiate analgesia and other causes have been excluded by cystoscopy.
Refer people urgently to urological services if they have haematuria or other urinary symptoms and a history of non‑muscle‑invasive bladder cancer.
Offer people with low-risk non-muscle-invasive bladder cancer (see the section on risk classification in non-muscle-invasive bladder cancer) cystoscopic follow‑up 3 months and 12 months after diagnosis.
Do not use urinary biomarkers or cytology in addition to cystoscopy for follow‑up after treatment for low‑risk bladder cancer.
Discharge to primary care people who have had low‑risk non‑muscle‑invasive bladder cancer and who have no recurrence of the bladder cancer within 12 months.
Do not offer routine urinary cytology or prolonged cystoscopic follow‑up after 12 months for people with low‑risk non‑muscle‑invasive bladder cancer.
Offer people with intermediate-risk non-muscle-invasive bladder cancer (see the section on risk classification in non-muscle-invasive bladder cancer) cystoscopic follow‑up at 3, 9 and 18 months, and once a year thereafter.
Consider discharging people who have had intermediate‑risk non‑muscle‑invasive bladder cancer to primary care after 5 years of disease‑free follow‑up.
Offer people with high-risk non-muscle-invasive bladder cancer (see the section on risk classification in non-muscle-invasive bladder cancer) cystoscopic follow‑up:
every 3 months for the first 2 years then
every 6 months for the next 2 years then
once a year thereafter.
For people who have had radical cystectomy for high‑risk non‑muscle‑invasive bladder cancer, see recommendations 1.6.1 and 1.6.2.
Ensure that a specialist urology multidisciplinary team reviews all cases of muscle‑invasive bladder cancer, including adenocarcinoma, squamous cell carcinoma and neuroendocrine carcinoma, and that the review includes histopathology, imaging and discussion of treatment options.
Offer neoadjuvant chemotherapy using a cisplatin combination regimen before radical cystectomy or radical radiotherapy to people with newly diagnosed muscle‑invasive urothelial bladder cancer for whom cisplatin‑based chemotherapy is suitable. Ensure that they have an opportunity to discuss the risks and benefits with an oncologist who treats bladder cancer.
Offer a choice of radical cystectomy or radiotherapy with a radiosensitiser to people with muscle‑invasive urothelial bladder cancer for whom radical therapy is suitable. Ensure that the choice is based on a full discussion between the person and a urologist who performs radical cystectomy, a clinical oncologist and a clinical nurse specialist. Include in the discussion:
the prognosis with or without treatment
the limited evidence about whether surgery or radiotherapy with a radiosensitiser is the most effective cancer treatment
the benefits and risks of surgery and radiotherapy with a radiosensitiser, including the impact on sexual and bowel function and the risk of death as a result of the treatment.
Offer people who have chosen radical cystectomy a urinary stoma, or a continent urinary diversion (bladder substitution or a catheterisable reservoir) if there are no strong contraindications to continent urinary diversion such as cognitive impairment, impaired renal function or significant bowel disease.
Members of the specialist urology multidisciplinary team (including the bladder cancer specialist urological surgeon, stoma care nurse and clinical nurse specialist) should discuss with the person whether to have a urinary stoma or continent urinary diversion, and provide opportunities for the person to talk with people who have had these procedures.
Offer people with bladder cancer and, if they wish, their partners, families or carers, opportunities to have discussions with a stoma care nurse before and after radical cystectomy as needed.
Consider adjuvant cisplatin combination chemotherapy after radical cystectomy for people with a diagnosis of muscle‑invasive or lymph‑node‑positive urothelial bladder cancer for whom neoadjuvant chemotherapy was not suitable (because muscle invasion was not shown on biopsies before cystectomy). Ensure that the person has an opportunity to discuss the risks and benefits with an oncologist who treats bladder cancer.
Use a radiosensitiser (such as mitomycin in combination with fluorouracil [5‑FU] or carbogen in combination with nicotinamide) when giving radical radiotherapy (for example, 64 Gy in 32 fractions over 6.5 weeks or 55 Gy in 20 fractions over 4 weeks) for muscle‑invasive urothelial bladder cancer.
In February 2015, this was an off-label use of mitomycin in combination with fluorouracil and carbogen in combination with nicotinamide. See NICE's information on prescribing medicines.
Seek advice from a specialist urology multidisciplinary team if symptoms of bladder toxicity after radiotherapy cannot be controlled with antispasmodics or non‑opiate analgesia and other causes have been excluded by cystoscopy.
Offer follow‑up after radical cystectomy or radical radiotherapy.
After radical cystectomy consider using a follow‑up protocol that consists of:
monitoring of the upper tracts for hydronephrosis, stones and cancer using imaging and glomerular filtration rate (GFR) estimation at least annually and
monitoring for local and distant recurrence using CT of the abdomen, pelvis and chest, carried out together with other planned CT imaging if possible, 6, 12 and 24 months after radical cystectomy and
monitoring for metabolic acidosis and B12 and folate deficiency at least annually and
for men with a defunctioned urethra, urethral washing for cytology and/or urethroscopy annually for 5 years to detect urethral recurrence.
After radical radiotherapy consider using a follow‑up protocol that includes all of the following:
rigid cystoscopy 3 months after radiotherapy has been completed, followed by either rigid or flexible cystoscopy:
every 3 months for the first 2 years then
every 6 months for the next 2 years then
every year thereafter, according to clinical judgement and the person's preference
upper‑tract imaging every year for 5 years
monitoring for local and distant recurrence using CT of the abdomen, pelvis and chest, carried out with other planned CT imaging if possible, 6, 12 and 24 months after radical radiotherapy has finished.
Discuss the role of first‑line chemotherapy with people who have locally advanced or metastatic bladder cancer. Include in your discussion:
prognosis of their cancer and
advantages and disadvantages of the treatment options, including best supportive care.
Offer a cisplatin‑based chemotherapy regimen (such as cisplatin in combination with gemcitabine, or accelerated [high‑dose] methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] in combination with granulocyte‑colony stimulating factor [G‑CSF]) to people with locally advanced or metastatic urothelial bladder cancer who are otherwise physically fit (have an Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1) and have adequate renal function (typically defined as a glomerular filtration rate [GFR] of 60 ml/min/1.73 m2 or more).
Offer carboplatin in combination with gemcitabine to people with locally advanced or metastatic urothelial bladder cancer with an ECOG performance status of 0 to 2 if a cisplatin‑based chemotherapy regimen is unsuitable, for example, because of ECOG performance status, inadequate renal function (typically defined as a GFR of less than 60 ml/min/1.73 m2) or comorbidity. Assess and discuss the risks and benefits with the person.
In February 2015 this was an off-label use of carboplatin in combination with gemcitabine. See NICE's information on prescribing medicines.
For people having first‑line chemotherapy for locally advanced or metastatic bladder cancer:
carry out regular clinical and radiological monitoring and
actively manage symptoms of disease and treatment‑related toxicity and
stop first‑line chemotherapy if there is excessive toxicity or disease progression.
Discuss second‑line chemotherapy with people who have locally advanced or metastatic bladder cancer. Include in your discussion:
the prognosis of their cancer
advantages and disadvantages of treatment options, including best supportive care.
Consider second‑line chemotherapy with gemcitabine in combination with cisplatin, or accelerated (high‑dose) MVAC in combination with G‑CSF for people with incurable locally advanced or metastatic urothelial bladder cancer whose condition has progressed after first‑line chemotherapy if:
their renal function is adequate (typically defined as a GFR of 60 ml/min/1.73 m2 or more) and
they are otherwise physically fit (have an ECOG performance status of 0 or 1).
Consider second‑line chemotherapy with carboplatin in combination with paclitaxel or gemcitabine in combination with paclitaxel for people with incurable locally advanced or metastatic urothelial bladder cancer for whom cisplatin‑based chemotherapy is not suitable, or who choose not to have it. (Also see the NICE topic page on bladder cancer for all our technology appraisal guidance on this topic.)
In February 2015, this was an off-licence use of carboplatin in combination with gemcitabine and gemcitabine in combination with paclitaxel. See NICE's information on prescribing medicines.
For recommendations on vinflunine as second‑line chemotherapy for people with incurable locally advanced or metastatic urothelial bladder cancer, see NICE's technology appraisal guidance on vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract.
For people having second‑line chemotherapy for locally advanced or metastatic bladder cancer:
carry out regular clinical and radiological monitoring and
actively manage symptoms of disease and treatment‑related toxicity and
stop second‑line chemotherapy if there is excessive toxicity or disease progression.
The point at which to use genomic biomarker-based therapy in solid tumour treatment pathways is uncertain. See the NICE topic page on genomic biomarker-based cancer treatments.
Offer palliative hypofractionated radiotherapy to people with symptoms of haematuria, dysuria, urinary frequency or nocturia caused by advanced bladder cancer that is unsuitable for potentially curative treatment.
Discuss treatment options with people who have locally advanced or metastatic bladder cancer with ureteric obstruction. Include in your discussion:
prognosis of their cancer and
advantages and disadvantages of the treatment options, including best supportive care.
Consider percutaneous nephrostomy or retrograde stenting (if technically feasible) for people with locally advanced or metastatic bladder cancer and ureteric obstruction who need treatment to relieve pain, treat acute kidney injury or improve renal function before further treatment.
If facilities for percutaneous nephrostomy or retrograde stenting are not available at the local hospital, or if these procedures are unsuccessful, discuss the options with a specialist urology multidisciplinary team for people with bladder cancer and ureteric obstruction.
Evaluate the cause of intractable bleeding with the local urology team.
Consider hypofractionated radiotherapy or embolisation for people with intractable bleeding caused by incurable bladder cancer.
If a person has intractable bleeding caused by bladder cancer and radiotherapy or embolisation are not suitable treatments, discuss further management with a specialist urology multidisciplinary team.
Evaluate the cause of pelvic pain with the local urology team.
Consider, in addition to best supportive care, 1 or more of the following to treat pelvic pain caused by incurable bladder cancer:
hypofractionated radiotherapy if the person has not had pelvic radiotherapy
nerve block
palliative chemotherapy.
A member of the treating team should offer people with incurable bladder cancer a sensitive explanation that their disease cannot be cured and refer them to the urology multidisciplinary team.
Tell the primary care team that the person has been given a diagnosis of incurable bladder cancer within 24 hours of telling the person.
A member of the urology multidisciplinary team should discuss the prognosis and management options with people with incurable bladder cancer.
Discuss palliative care services with people with incurable bladder cancer and, if needed and they agree, refer them to a specialist palliative care team (for more information, see recommendation 1.1.4 on holistic needs assessment and NICE's guidelines on improving supportive and palliative care for adults with cancer and improving outcomes in urological cancers).
Offer people with symptomatic incurable bladder cancer access to a urological team with the full range of options for managing symptoms.