Wednesday, December 19, 2007

Embarrassed by incontinence? Now you don't have to be
What started as one woman's attempt to help her mother with an embarrassing condition has just won a major medical award - and could help transform the lives of thousands of others who suffer from incontinence.

The device - Incostress - had the most unlikely of beginnings.

On a shopping trip in Swansea ten years ago, Gaynor Morgan noticed her mother Carole freeze in the middle of a department store, and then panic, insisting that they had to go home immediately.

It was only when they were safely back that Carole burst into tears and explained that she had wet herself. She had coughed and leaked urine, and was terrified other shoppers would notice the wet patch.

'She was so embarrassed,' says Gaynor. 'It was only then that she told me it had been going on for months.'

Carole, then only 51, withdrew to the house, rarely going out - 'she wouldn't go shopping or out with friends for fear of wetting herself,' says Gaynor.

When Carole saw her GP and told her about the incontinence, he treated her for depression, prescribing antidepressants.

Prompted by her mother's distress, Gaynor searched the market for products that might help but found only incontinence pads.

The lightbulb moment came two years after Carole first developed the problem when she mentioned that it wasn't as bad during menstruation when using a tampon.

As Carole had previously been a nurse (for 15 years), and Gaynor had geriatric nursing experience, they used their physiological knowledge to devise something which would reduce the flow through the urethra and support the bladder.

The solution was a type of tampon. They sat down at the kitchen table to make a simple prototype using Gaynor's five-yearold daughter's art material - self-hardening clay - then sealing it with silicone sealant.

Carole covered it with a condom for hygiene reasons, and tested it.

'She started doing star jumps in the middle of the kitchen,' says Gaynor, 'and though she had a full bladder, she didn't leak at all. "It works, it works!" she yelled. She wore it every day after that, and started to go out again without the slightest leak.'

Her confidence - and social life - returned and she no longer needed antidepressants.

Carole told a friend about her transformation; the friend told another, who wanted one too, and soon the women had made half a dozen.

Then Gaynor found a liquid latex which dried faster than silicone - and in 2000, she got a patent for her groundbreaking invention.

Incostress is shaped like a ribbed tampon and made of medical grade silicone. Gaynor had samples made commercially, and once the product was properly validated to EC standards, in 2005, she approached urologists at her local hospital in Swansea to run trials.

'Though it didn't work for everybody it worked very well for between a quarter and a third of women,' says Simon Emery, consultant urogynaecologist at Singleton Hospital.

Although some women found it hard to hold the early prototype in, it's now been altered and the ribbing was added, so it stays in place more easily. So effective was it for some women that they took their names off the list for surgery.

As well as closing the urethra and supporting the neck of the bladder to stop an involuntary leakage, the minor effort to keep the device in place strengthens the pelvic floor, by encouraging the muscles to work. Those with weak pelvic floor muscles may need to remove the device to urinate normally.

Carole's sudden death in 2004, from fluid in the lungs after a heart attack, spurred Gaynor on to form her own company, and with backing from the Wales Innovative Network-UK she went into production with more sophisticated versions of the Incostress.

The device has just won a gold medal for innovation in the medical category at the British Innovation and Technical awards.

Urinary incontinence affects nearly ten million women in the UK, according to the charity Continence Foundation.

'It is a huge problem for millions of women in this country,' says Frank Chinegwundoh, consultant urological surgeon at Barts Hospital and Newham University Hospital in London.

'Although it's not painful, it is a socially embarrassing condition which can prevent women from going out or taking exercise, and can affect sexual relationships.'

As a consultant urological surgeon at Bristol Urological Institute, Marcus Drake regularly sees women who burst into tears in his clinic in despair.

'If it was cancer, say, there would be a huge amount of sympathy for these women. But incontinence is a huge problem which is massively underestimated and yet very prevalent. The trouble is, women daren't talk about it even with their closest friends - they're ashamed of it.'

The most common form is stress incontinence - when a small amount of urine is leaked during activity or coughing and sneezing.

This is sometimes combined with urge incontinence where the bladder suddenly empties.

Urine is held in the bladder and emptied through the urethra to outside of the body. The bladder is supported and kept in shape by the pelvic floor muscles, a large hammock of muscles. The openings from the bladder and urethra, bowels and vagina all pass through the pelvic floor.

Pelvic floor muscles naturally squeeze when put under pressure - for instance when you laugh, lift anything heavy or cough - and so ensure the bladder outlet remains closed. But these muscles can become weakened.

Ageing and being overweight can exacerbate the problem, but many women's problems start in pregnancy, as childbearing and childbirth weaken the pelvic floor.

One study found that 38 per cent of women experience continence problems three months after birth - and around 42 per cent of women wait 15 years before seeking treatment.

The good news, say the experts, is that something can always be done to improve - and cure - bladder weakness.

Last October, the National Institute for Health and Clinical Excellence launched new guidelines for treatment.

The first step is lifestyle changes, including losing weight for women who are very overweight, and giving up smoking, since a chronic cough can make leakage worse.

Women then do pelvic floor exercises for at least three months.

If this doesn't work women may by offered drug treatment to - tighten the valve in the urethra.

And if this fails women can be offered surgery. One option is using a strip of synthetic tape to form a sling supporting the urethra.

'Surgery is reasonably effective, but all procedures carry risks, including infection and blood vessel injury,' says Dr Chinegwundoh.

'Things can go wrong, so women need to try simple methods before considering surgery.'

It seems nothing could be simpler than the Incostress - as Gaynor herself discovered when she, too, developed incontinence.

'I know now that there are lots of people like me, but they won't talk about it, and many won't look for help,' she says. 'But if the kitchen tap was leaking, we'd get it fixed, not just put a cloth under it.

'If you've got a leak, don't suffer in silence - go out and get some help, because you are not alone.'


Thursday, December 13, 2007

'Mixed blessing' statins cut risk of stroke - but can trigger brain bleeds

Taking statins can significantly cut the risk of having a repeat stroke, research has shown.

The drugs have already been prescribed to millions of Britons because they are believed to cut the risk of heart attacks.

They do this by reducing a patient's cholesterol - which is also believed to be a risk factor for strokes. A U.S. study found that those who had already had one ischaemic stroke - caused by a clot blocking a blood vessel in the brain - reduced their chances of having another by 16 per cent if they took a statin called atorvastatin.

However, a secondary analysis published in the journal Neurology discovered that this benefit was partially undermined by a slight increase in the risk of suffering a haemorrhagic stroke, where a ruptured blood vessel bleeds into the brain.

This type of stroke is far less common, accounting for just one in ten of all cases.
Of those taking atorvastatin, 2.3 per cent experienced a haemorrhagic stroke compared with 1.4 per cent of those taking a placebo.

However, the study in Neurology also backed up the U.S. research's findings that statins are effective at lowering the risk of the more common ischaemic stroke.

Experts said yesterday that having high cholesterol is one of the biggest risk factors for a stroke and patients should not stop taking preventative drugs without seeking medical advice. Ellen

Mason, of the British Heart Foundation, said: 'Haemorrhagic strokes are rare in comparison to ischaemic strokes, which are caused by blood clots.

"Taking a statin, such as atorvastatin, reduces the risk of having an ischaemic stroke and people should not be frightened of taking these."

She added: "People who have had a haemorrhagic stroke before will probably continue to benefit from taking atorvastatin - as there is a substantial drop in the overall risk of heart attacks and ischaemic strokes, but only a small increased risk of haemorrhagic stroke."

Around 3.4million Britons are prescribed statins, which are said to save around 10,000 lives a year.

The five-year study involved 4,700 patients, who had suffered a full-blown stroke or mini-stroke.

It was funded by Pfizer - the manufacturer of atorvastatin, which is also known as Lipitor.

It looked at patients aged around 63 from Europe, Africa, Australia, the Middle East and the U.S., who were recruited within six months of suffering a stroke.

Most were already being treated with aspirin - which thins the blood, reducing the chances of having a heart attack - and those with high blood pressure were taking medication to lower it.

The researchers randomly assigned patients to receive either the maximum recommended dose of atorvastatin or an inactive pill.

The study found that 80mg a day of statins reduced the risk of fatal and non-fatal ischaemic strokes by 16 per cent, probably by lowering levels of cholesterol.

This compared with an increase in the risk of haemorrhagic strokes of 0.7 points - from 1.4 per cent to 2.3 per cent.

Dr Larry Goldstein, of Duke University Medical Center in North Carolina, who led the study, said this small increase "must be balanced" against the overall drop in risk.