In April, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on reclassifying Aquiette 2.5mg tablets (oxybutynin hydrochloride) from a POM to a Pharmacy medicine. The indication: milder symptoms of overactive bladder in women aged between 18 and 65 that can’t be controlled by bladder training alone. 

According to Bladder Health UK, one in six adults over the age of 40 suffer from overactive bladder, and nearly 50 per cent of patients don’t seek help. Women are more likely than men to be affected. Last November, GlobalData reported that cases of overactive bladder are increasing worldwide, and are expected to rise further as populations continue to age. 

Overactive bladder often occurs when the detrusor muscles of the bladder are contracting too often, or spontaneously. There is often no obvious cause. Symptoms include having to urinate at least eight times in the day, more than once during the night, sometimes leading to accidental leaks (bladder incontinence). 

Bladder training helps people to regain control by suppressing the bladder muscle contractions. Instead of rushing to the toilet as soon as they get the urge, they have to try to hold on for as long as possible. Over time, they should gradually increase the capacity of their bladder and the time interval between passing urine.

Oxybutynin is an anticholinergic drug that helps overactive bladder symptoms by relaxing the detrusor muscles. The reclassification consultation has been welcomed by many healthcare professionals, as women are often reluctant to discuss sensitive issues such as bladder control with their GP, but may be more likely to seek help if they know that an effective medicine is available without a prescription. 

“As a pharmacist myself, I know how important we are in helping people to self care, and I see that pharmacists will play an increasingly important role in communities as medical advisors,” says Anna Maxwell, Maxwellia CEO. “It’s vital that more medicines are reclassified, enabling people to access them following a short consultation with a pharmacist.”

Some healthcare professionals are concerned that oxybutynin can cause side effects, such as a dry mouth, vertigo and constipation, and recent research has linked the use of anticholinergic medicines with dementia in later life. If oxybutynin is reclassified, pharmacists would have access to training materials and a checklist to enable them to identify women who can be supplied with it safely.

"women at the highest risk of pelvic floor dysfunction should be identified early and offered interventions to prevent symptoms developing"

“The switch may work as long as community pharmacists review all of the patient/customer’s medicines and consider the anticholinergic burden,” says Dr Nuttan Tanna, pharmacist consultant at NW London Hospitals NHS Trust. “There is also some debate as to whether the oxybutynin dose at P level would be enough to help with overactive bladder symptoms, and whether it’s best to just recommend pelvic floor exercises with or without bladder retraining. With serious overactive bladder symptoms, the patient is reviewed by their GP or a urogynaecologist, who prescribes and takes responsibility for the medication.”

Bladder health awareness raising

As cases of overactive bladder and bladder incontinence continue to rise, raising awareness of bladder health is becoming increasingly important. Essity – through its TENA brand – has worked with the charity Bladder Health UK and ITN to produce a video that was premiered at a major conference for healthcare professionals. The Bladder Health: Breaking Boundaries news and current affairs-style video, anchored by ITN presenters Sharon Thomas and Duncan Golestani, was screened at the Association for Continence Advice annual conference in May. 

Also in May, the Pelvic Floor Society published Seizing the opportunity to improve patient care: Pelvic Floor Services in 2021 and beyond. Developed by more than 30 pelvic floor and continence experts, the report highlights that a lack of ‘joined-up’ services for pelvic floor disorders has led to inefficiencies in care and frustration for patients, and that pelvic floor disorders and continence issues have long been neglected. 

“Millions of people are suffering life-changing bladder and bowel problems that can, and should, be fixed,” says Professor Charles H Knowles, professor of surgery at Queen Mary University of London and consultant surgeon at Barts Health NHS Trust. “Our report puts forward six areas where small changes will make a big impact on services, enabling patients to receive the timely care they need.”

According to the report, the taboo surrounding pelvic floor disorders is a major barrier to treatment, while some patients don’t realise that treatments may be available. A national, well-funded campaign is needed to break down the taboo and raise awareness of the treatment options; it should offer education on the maintenance of bladder and bowel health. More also needs to be done to ensure that when people do seek help from a healthcare professional, they are taken seriously and signposted to someone who can help them. 

A new NICE guideline on pelvic floor dysfunction was published in December 2021. This condition affects the normal function of the pelvic floor muscles around the bladder, anal canal and vagina, and can lead to a range of problems, including urinary incontinence and emptying disorders of the bladder. It can have a significant impact on people’s quality of life.

The guideline states that, ideally, women at the highest risk of pelvic floor dysfunction should be identified early and offered interventions to prevent symptoms developing. 

Modifiable risk factors include a body mass index (BMI) over 25 kg/m², smoking, a lack of exercise, constipation and diabetes. Non-modifiable risk factors include age, family history of incontinence or overactive bladder, gynaecological cancer (and treatments), gynaecological surgery, fibromyalgia, chronic respiratory disease and cough, pregnancy over the age of 30, and assisted vaginal delivery. 

Treatments and preventative measures vary, but include pelvic floor muscle training, which involves squeezing the pelvic floor muscles 10 to 15 times, several times a day. Information on pelvic floor training could be given alongside over-the-counter continence products, tailored for different age groups and times of life (e.g pregnancy). It could also be provided when women ask for advice about perimenopause and menopause.

"There are a range of factors that cause urinary incontinence, such as a urinary tract infection, certain types of medication and even lifestyle choices like drinking caffeine and alcohol"

While education and literature often focus on bladder incontinence in women, it’s important that bladder incontinence in men is not overlooked. According to Saheed Rashid, managing director at BXTA, bladder incontinence can be a sign of prostate cancer. “It is important that men, and also pharmacists, are aware of the potential symptoms, which will help to identify the men most at risk,” he says. “In turn, pharmacy teams can help redirect patients to their GP to double-check any concerns they have.” 

When diagnosed, the treatment option is a crucial decision to determine quality of life. Low-dose rate brachytherapy (LDR-B) – a targeted form of internal radiotherapy – has been an established treatment for prostate cancer for over two decades, yet many men remain unaware of this pathway. The main type of surgery for prostate cancer, a radical prostatectomy, can often have the side effect of urinary incontinence, as well as impotence and longer recovery time.”

Bladder incontinence

“A weak bladder is no laughing matter,” says Stephanie Taylor, managing director at Kegel8. “It’s an unfortunate reality that millions will experience urinary incontinence at some point in their life. However, despite this fact, it remains a silent issue rarely discussed or reported to doctors.”

The most common types of bladder incontinence are: 

• Stress incontinence. Urine leaks out when the bladder is under pressure: for example, when someone coughs, sneezes, laughs or exercises. It may be due to weak or damaged pelvic floor muscles
• Urge incontinence. Urine leaks following a sudden, intense urge to urinate, or soon afterwards – this may be associated with overactive detrusor muscles
• Overflow incontinence (chronic urinary retention). The person is unable to fully empty their bladder because of a blockage, which causes frequent leaking. This is most common in men with an enlarged prostate, or in people with bladder stones or constipation
• Total incontinence. The bladder can’t store any urine at all, which causes frequent leaks. It may be present from birth or be associated with a spinal injury or a fistula (hole between the bladder and a nearby area)
• Mixed incontinence. A mixture of stress and urge incontinence.

Ms Taylor says that it’s important to understand factors leading to incontinence, as this will determine the best way to treat it. “If incontinence is caused by an underlying condition, ensure this is treated first,” she says. “There are a range of factors that cause urinary incontinence, such as a urinary tract infection, certain types of medication and even lifestyle choices like drinking caffeine and alcohol. Very often, incontinence is caused by problems with the muscles and nerves that help the bladder hold or pass urine. These pelvic floor muscles may weaken during pregnancy or due to obesity or ageing.”

Management tips to pass on 

Many people use pads, pants, specially adapted clothing and other incontinence products to cope with leakages. These may be helpful while waiting for a diagnosis or a treatment to work, but they are not a cure. If someone is buying products regularly, it’s important to try to broach the topic to discuss any possible underlying triggers (e.g lifestyle factors or medical conditions). 

Physical activity, weight loss, stopping smoking, managing constipation and eating a healthy diet may help to prevent pelvic floor dysfunction and treat urinary incontinence, overactive bladder and pelvic organ prolapse. If someone has an overactive bladder or urinary incontinence associated with pelvic floor function, they should reduce their caffeine intake and modify their fluid intake (aiming to drink one to one and a half litres a day). Other dietary factors that can irritate the bladder include drinks containing aspartame, hot chocolate, green tea, alcohol, citrus fruit juices, tomatoes and spicy food.

"Millions of people are suffering life-changing bladder and bowel problems that can, and should, be fixed"

Women of all ages should be encouraged to do pelvic floor muscle training for at least three months, to reduce and prevent symptoms of stress urinary incontinence or mixed urinary incontinence. This should be supervised by a physiotherapist or suitably qualified healthcare professional. Men can do pelvic floor muscle exercises as well to improve their bladder control.

“One of the easiest ways to start pelvic floor retraining is to do so with breathing exercises,” says Lyndsay Hirst, physiotherapist at Your Pilates Physio. “The diaphragm and pelvic floor work together. As we exhale, the pelvic floor muscle contracts. Sit up straight, take a deep breath in then continue to blow all that air out. Another useful tip is to use visualisation. Sit up straight and lean forward slightly. Imagine under where you are sitting there is a jellybean. Imagine trying to lift the jellybean using your pelvic floor, you can also try to do this as you exhale.” 

If women can’t perform an effective pelvic floor muscle contraction, they may benefit from biofeedback techniques, electrical stimulation or vaginal cones. Supervised exercise, such as yoga, may also help, as will increasing general activity levels.

“A pelvic floor toner takes the guesswork out of exercises,” says Ms Taylor. “But people shouldn’t use a pelvic floor toner if they have recently given birth, are pregnant or have recently had any pelvic surgery. They should start noticing a difference within six weeks, although this is not a definitive guideline. If muscles were extremely weak, they may not see improvement for double that time. Similarly, some (albeit lucky) women can see pelvic floor muscle improvement within two to three weeks. If pelvic floor exercises really aren’t working, we recommend they go and see their GP.”

If nonsurgical approaches for bladder incontinence are not successful, a GP may suggest a surgical approach instead. Overactive bladder and/or urge incontinence may be treated with a Botulinum toxin A (Botox) injection into the sides of the bladder to relax the bladder muscles. Repeated injections may be required, and this is not a licensed indication for Botox. For urge incontinence, there is sacral neuromodulation using a device that stimulates the detrusor muscles with an electrical current so they contract, to improve signals from the brain to the muscles. Overflow incontinence can be treated with catheterisation. It’s important that people discuss the pros and cons of each surgical procedure – especially the risk of complications.

Views of the P3pharmacy category panel

“This has become even more important with patients being more aware of our ability to order in items at their request. One of our staff is very keen on the promotion of this ability and her work is paying dividends. The Tena range is our go-to. Excellent branding and the large pack size means we can make these visible even on lower shelves. We only display one or two from the range as this sparks questions from customers for other sizing. This prevents taking up valuable shelf space. Bed pads are the one item that seems not always to be available, so we make sure we have a few tucked away somewhere in the shop.”

Gareth Evans, Wansford Pharmacy, Peterborough

“Demand increases every year as people are more aware of what’s available. We have signposting from other health professionals too, referring them to us. There are more choices; they look nicer too. We simply can’t order enough to keep up with demand. Customers ask about absorbency, size and which is best among the male, female and unisex products. TENA is the brand leader and is now all we sell. There is so much choice we don’t need another brand and customers ask for it by name. NHS products are quite basic, so many customers prefer to pay for a better product they will be happier using.”

Lila Thakerar, Shaftesbury Pharmacy, Harrow

“With an ageing population, this category is becoming more important and questions more common. It can be an embarrassing topic to discuss and patients may be reluctant to ask questions, so it may be better to approach patients purchasing certain products. If they have been suffering for a while, they may not realise certain cases of incontinence can be treated; the symptoms could be due to something else – for example, diabetes. The TENA brand sells the best. Stock a variety of sizes to cover a range of patients and check prices with shops nearby to be competitive.”

Ellis Nugent, Davies Chemist, Gurnos, Swansea