Effective – at a heavy price.

It sounds crazy, but Botox injections in the bladder may help women with urinary incontinence – the idea is to paralyse troublesome overactivity of the detrusor (bladder wall) muscle.

But detrusor over activity is tricky. It waxes and wanes, and some cases may even be psychological. If symptoms improve, we can’t be sure the Botox did the trick. Complications like urine infection and retention happen without treatment, so it’s difficult to know how much to blame on the Botox. We need good quality, randomised controlled trials.

Unfortunately previous trials have been small, badly designed and have failed to give clear answers. But my colleague from Leicester, Doug Tincello, has just published the best yet. I chaired the independent committee that made sure it was done right, so perhaps I’m biased. But it really is a good trial.

It was funded by a charity set up by Jon Moulton, the venture capitalist behind Alchemy Partners, who has turned round dozens of ailing British firms and made zillions along the way.  Early on Moulton gave Doug a hard time. He wanted results today, and was hacked off at the slow rate of progress. He had a point. The NHS needs a few more Jon Moulton’s!

But eventually 240 women participated. Neither they nor their doctors knew if they had got Botox or placebo, and nearly all were followed-up. The design was pre-specified so there was no possibility of selective reporting of what enthusiasts wanted to hear. And the results?

The stuff works. It really does. Botox-treated women were much less likely to be incontinent at all the time points assessed.

But the side effects were considerable. 1 in 3 women had a urine infection after Botox, compared with 1 in 10 in controls.  Maybe a 3-fold increase doesn’t matter, antibiotics should cure it.

More worryingly 16% of Botox-treated women (4% of controls) were unable to pass urine at all and were still regularly self catheterising at 6 months! It’s not just the indignity. Serious infection may spread to the kidneys. Doug is following them up long term.

Finally Botox gradually wears off – symptoms had recurred in 70% by 6 months – so the whole procedure, which usually requires a general anaesthetic, has to be repeated.

Personally I’d advise women against Botox. But I don’t suffer from detrusor overactivity. Some women find it so disabling that they would put up with even these side effects for relief. At least they know what they’re letting themselves in for now.

For the full report click here.

Jim Thornton