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Clinical trial leads to major advance in NHS treatment of Stress Incontinence

PelvicToner now on NHS Prescription

For the first time GPs can now offer a more effective and speedier treatment option to the millions of new mums and women of all ages that present with the distressing symptoms of Stress Urinary Incontinence (SUI).

This is the first major advance in the NHS primary care treatment of SUI for over 60 years.

Following a highly successful clinical trial and a robust cost-benefit evaluation, the NHS has decided that the PelvicToner™ will be available on prescription with effect from January 2011. The PelvicToner will be the only product available under the brand new Drug Tariff category of Pelvic Toning Devices.

NICE Best Practice currently recommends that women be individually assessed, trained and supervised by a specialist in a three month programme of Pelvic Floor Exercise (PFEs). But very few women receive this Gold Standard Treatment and are generally just offered women a simple instruction sheet to use unsupervised.

In clinical trials, published in the British Journal of Urology International, the PelvicToner was shown to be as effective as Supervised PFEs with the added benefit that it helped women confidently identify their pelvic floor and exercise more effectively by squeezing against a mild resistance. The result is a very high level of satisfaction with over 80% of PelvicToner users reporting significant improvement within a couple of weeks.

The use of the PelvicToner should also bring significant cost benefits to the NHS. Prescribing the PelvicToner in the first instance could and should save the NHS £millions (there are 4,000,000 women in the UK with the problem) and enable the NHS to focus scarce resources such as Continence Advisors, specialist physiotherapists and surgeons on the most needy cases.

The author of the BJUI article and the research leader, Professor Marcus Drake of the Bristol Urology Institute, says: "continence service provision is patchy and this sort of product empowers women, gives them better privacy and the prospect of not wasting their time. In our study the PelvicToner aided women to identify their pelvic floor confidently. It increases patient choice and may promote subsequent compliance and sustained efficacy.''

Specialists in the field have long recognized the weaknesses in the current system. Clinical estimates suggest that a third of women cannot identify their pelvic floor and how to squeeze it in the first place, so giving them just an instruction sheet is of no real benefit.

Many specialists note that the general level of training is poor. Supervised PFEs do not expect to see significant improvements inside three months and women just given a sheet of paper rarely see any improvement at all. All this leads to frustration, low motivation and very poor compliance. In contrast, PelvicToner users report rapid improvement and demonstrate eagerness to exercise on a regular basis to maintain a strong and healthy pelvic floor.

Barry Fowler, MD of the manufacturer SPM Ltd, said: "This recognition is a major boost for the PelvicToner and the women who are happy to consult their GP for advice. But there are still millions of women who are too embarrassed to even consult with their doctor because of the taboo that surrounds stress incontinence. These women can now help themselves and purchase with confidence knowing that the PelvicToner is cheap, simple to use and of proven effectiveness.''

The PelvicToner™ is a simple, portable exercise device that works by strengthening the walls of the pelvic floor through mild resistance training. This tightens the muscles around the neck of the bladder and prevents urine leaking out when you cough, sneeze, laugh or make a sudden movement.

The PelvicToner costs just £31.99 (including p&p) and can be purchased from www.pelvictoner.co.uk or from 0117 968 1414.

From January 2011 the PelvicToner will be available on prescription in England and Wales and from pharmacies nationwide. For pharmacies the PIP Code is 359-4520.

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NOTES FOR EDITORS
For more information contact Barry Fowler at press@spml.biz. 0117 968 0171 or 07768 233670

Stress incontinence occurs as a result of reduced support for the bladder, usually by 'sagging' pelvic floor muscles commonly brought-on by childbirth, the natural effects of the menopause, obesity and a lack of regular, effective pelvic floor exercise.

It accounts for 65 per cent of female urinary incontinence and affects around 4 million women in the UK. One in ten women in the workplace suffer, as do a third of all new mothers.

Weak pelvic floor muscles are also a key cause of a lacklustre sex life and PelvicToner exercises have been shown to significantly improve the ability to achieve orgasm. In a user survey, 80% of respondents reported an improved sex life and 62% also reported that their partner noticed improved vaginal tightness.

The benefits of an effective pelvic floor exercise regime have been acknowledged since Arnold Kegel launched his eponymous exercises in 1948. However, the key recommendations of his research went largely unnoticed and few women appreciate how to exercise correctly. When first shown the PelvicToner, Paul Abrams, Professor of Urology at the Bristol Urological Institute said:

"It is 60 years since Arnold Kegel proposed pelvic floor exercises as a treatment for stress incontinence but a simple, effective method of putting all his principles into practice has eluded us. The PelvicToner™ seems to meet all the requirements that Kegel envisaged - it is a simple, patient-friendly, progressive resistance exercise device and provides feedback to the patient that the correct muscles are being engaged.”

Research shows that women will suffer the symptoms of stress incontinence for an average of 4 years or more before consulting their GP. Most women will not discuss the problems with their partner, relatives or friends and suffer in silence. Greater openness and media coverage of the issues will thus benefit millions of women.

The two-year randomised study of the PelvicToner at the Bristol Urological Institute (BUI) monitored participants for 16 weeks. The BUI, Britain's leading urodynamics research centre, is based at Southmead Hospital, Bristol.

The researchers said the PelvicToner was ''easy to use'' and proved ''particularly helpful'' in the majority of cases. A total of 86 per cent gave a satisfaction rating of seven-out-of-ten or higher. 86 per cent of participants who used the PelvicToner reported a ''significant'' improvement in their condition.

In supporting the submission to NHS Prescription Services and the robust evaluation that ensued, Professor Drake noted: “Primary care does not provide supervised pelvic floor exercises except in rare cases. The vast majority of women are handed a leaflet and not examined. Supervised PFEs are known to be better than that rather poor service. Thus, in being equivalent to supervised PFEs, PelvicToner is better than unsupervised. The review should not have neglected the distinction between supervised and unsupervised; supervised means that women are actively taught the PF contraction by a highly trained healthcare professional (and hence it is expensive).”

There are a variety of products that purport to strengthen the pelvic floor, but the clinical trials confirm that the PelvicToner is much more effective than expensive electrical stimulation devices and weighted vaginal cones. These alternatives are not recommended by NICE and are not universally advocated by clinicians as they have yet to produce sufficient evidence of efficacy.

The PelvicToner is the first and only pelvic toning device to be recognised by the NHS and a special new category of ‘Pelvic Toning Devices’ has been created on the Drug Tariff IXA.

The PelvicToner was developed in the UK and is manufactured in the SouthWest.

ENDS