Botox - a potential for therapy of weak bladders in women

By Dr. Ananya Mandal, MDMar 13 2012

Botox could help people with weak bladders – a common condition called urinary incontinence.

The study, published in the journal European Urology, was carried out at eight uro-gynecology centers in the UK from 2006 to 2009 by researchers from the University of Leicester. A total of 240 women were split into two groups, with 122 women given Botox and 118 receiving a dummy treatment. Researchers found improvements across a range of symptoms, including wetting oneself and feeling a need to rush to the toilet, and how often the women 'leaked' urine.

Injecting the toxin directly into the wall of the organ was found to improve symptoms among women with incontinence. On average, the number of times they suffered an episode of incontinence fell from six times a day to under once a day. The number of times they felt an urgent need to go to the toilet also fell, from around eight times a day to three times a day. About four out of 10 women treated with the powerful neurotoxin became continent again after six weeks and a third were still continent six months after treatment. The effects started to wear off after about six months.

However, there were side-effects - including some women needing to use a catheter to go to the toilet because of paralysis in the bladder muscle. Urinary tract infection was reported at least once during six months by a one-third of women in the botox treatment group, compared to 10% in the placebo group. Those given botox also reported greater difficulty emptying their bladders that required self-catheterisation to remove their urine: 16% of the botox group compared to 4% of the placebo group.

It is unclear how many people in the UK suffer urinary incontinence, but it is thought to affect more than 50 million people in the developed world. Figures from a previous UK study found that 13 per cent of women and five per cent of men had some degree of urinary incontinence. Women are more at risk, owing in part to the effects of childbirth. Current treatments include pelvic floor exercises, behavioral therapy and drugs that can have side-effects, such as a dry mouth, constipation and blurred vision.

Dr Douglas Tincello, senior lecturer from the University of Leicester and honorary consultant gynecologist at University Hospitals of Leicester NHS Trust, led the latest study. He said some patients affected by the condition 'find it hard to cope'. He continued, “We found that a single treatment with botulinum toxin was a very effective treatment for the symptoms; patients were able to pass water one or two times less often during the day, and also noticed far fewer times when they had bad feelings of urgency and had to rush to the bathroom.”

Dr Tincello said he was 'excited' by the results of the trial, saying Botox “works so much better than the drugs we have.” “Our work may lead to Botox being licensed to treat overactive bladder syndrome in the UK,” he said.

The study was funded by the Moulton Charitable Trust, Wellbeing of Women and the Rosetrees Trust, and is the largest of its kind into Botox not to be funded by drug firms. Liz Campbell, director of Wellbeing of Women, said, “This is a horrible condition and often means otherwise healthy active women curtail their lives, becoming prisoners in their homes. It is rarely discussed but affects many women.”

Botox is currently not approved for the treatment of an overactive bladder in the UK, according to the Medicines and Healthcare products Regulatory Agency (MHRA). It is licensed in some European countries and Ireland for patients whose incontinence results from conditions such as spinal cord injury and multiple sclerosis (MS).

It is important to note that the study participants did not have stress incontinence, which is a common cause of urinary incontinence. Therefore, the results of this study cannot be generalised to all women with symptoms of overactive bladder or incontinence, but can only be applied to those with diagnosed overactive bladder syndrome (or detrusor overactivity).