A study to find the best treatment for early bladder cancer (BRAVO)

The team found that it wouldn’t be possible to run a larger trial comparing the treatments. This was because it was difficult to find enough people to take part in this study.

Study design
The team screened 407 people who they thought might be suitable to take part. Of those, 215 people fitted the entry conditions  and the team asked 185 to join. 

51 people were consented  and 50 agreed to be randomised

Of those, 43 people had their trial treatment:

• 20 had surgery to remove the bladder
• 23 had BCG into the bladder

BRAVO results - randomisation diagram

Those who had BCG had it for up to 1 year as long as it was working and the side effects weren’t too bad. 

The team followed the people who took part for up to a year. Those who had BCG had regular tests to look inside the bladder (cystoscopies ). Everyone also had regular scans to check if the cancer had spread. 

Results

Why people didn’t join the study
The team looked at why some people, who had been asked to take part didn’t want to. They gave the following reasons:

• 77 people preferred to have BCG
• 39 people preferred to have surgery to remove the bladder
• 27 people didn’t want to be put into a randomised group
• 8 people were worried about joining a trial
• 3 people didn’t say why 

Results for the BCG group
23 people had BCG into the bladder. 

After the first 6 weeks of treatment everyone had a cystoscopy to look inside the bladder. The team:

• found 4 people had cancer in the lining of the bladder (non muscle invasive bladder cancer)
• found 18 people had no sign of cancer 
• didn’t have the results for 1 person

At 4 months they had the results for 16 people. They found:

• 3 people had cancer in the lining of the bladder (non muscle invasive cancer)
• 13 people had no sign of cancer 

At 4 months follow up, 4 people went on to have surgery to remove the bladder. 

Everyone had regular CT scans during the trial. At the end of the trial they found that 2 people had bladder cancer that had spread elsewhere in the body. 

Results for people who had surgery
20 people had surgery to remove the bladder. At 12 month follow up, information was available for 9 people and of these 9, everyone was free of cancer. 

Quality of life
The research team asked people taking part to fill out a quality of life questionnaire before, during and after treatment. 

The results showed that there wasn’t much of a change in quality of life for people in either group at 12 months.

For those who had surgery, quality of life went down for a few months afterwards. It then began to improve. At 6 to 12 months it was back to about the same level as before surgery. 

There was little change in quality of life in those who had BCG treatment into the bladder. 

Side effects
The team looked at the side effects of treatment. They say most of them were mild.

• 15 out of 23 people in the BCG group had at least one side effect
• 13 out of 20 people in the surgery group had at least one side effect 

The most common side effects of BCG into the bladder included:

• tiredness
• muscle pain
• pain or burning when passing urine
• passing urine frequently 

The most common side effects after surgery included:

• chest and wound infections
• a short delay before the bowels started to work properly
• sepsis
• constipation 

Conclusion
The research team concluded that it wouldn’t be possible to run a larger trial comparing these treatments. 

This study wasn’t designed to work out which treatment worked best. The team say some people are best suited to have surgery and others to have BCG treatment. 

The researchers suggest their findings are used to tell people about the risks of each treatment. The researchers hope these findings will help doctors decide the best treatment for each person based on their individual risk. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them.

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.