The Pelvic Toner
The Pelvic Toner, a device available on prescription in the UK, has been missed out of UK guidelines for clinicians treating female incontinence.
The publisher of a book about pelvic floor muscles and exercises to improve female incontinence, The Kegel Legacy, has criticised recent guidelines from the UK's National Institute for Health and Care Excellence (NICE) saying they ignore cheaper non-surgical pathways for treatment of female incontinence. The press release containing their critique is as follows.
No wonder that the NHS is in a financial mess! The newly published NICE Clinical Guidelines (CG171) that review the treatment of urinary incontinence in women focus entirely on expensive surgical and pharmaceutical intervention and ignore developments in cheap, effective non-invasive options.
However, the review must be welcomed for once again emphasising the scale of the problem, the cost to the NHS and the fact that, due to a lack of effective communication of the issues by the media and the medical profession, most women are in ignorance of the issues and suffering unnecessarily for very many years.
Ignorance And Embarrassment
The review, published on 11 September, highlights that ignorance and embarrassment are key factors:
“Urinary incontinence is an embarrassing problem to many women and thus its presence may be significantly underreported. In a UK community study, the prevalence of UI known to the health and social service agencies was 0.2% in women aged 15–64 years.
Where the most inclusive definitions have been used (‘ever’, ‘any’, ‘at least once in the last 12 months’), prevalence estimates in the general population range from 5% to 69% in women 15 years and older, with most studies in the range 25–45%.
Some women may not see their UI as a major problem. For others, who do perceive a problem with which they would like help, there are often barriers to presentation. Women may take up to 10 years before seeking help. They may be too embarrassed to seek advice, may not wish to bother their general practitioner (GP), may believe UI to be a normal consequence of the ageing process or may not appreciate that treatments are available.”
Serious Social And Health Implications
There are serious social and health implications for the women who suffer in silence:
“In adult women with UI, 60% avoid going away from home, 50% feel odd or different from others, 45% avoid public transport and 50% report avoiding sexual activity through fear of incontinence. Serious psychiatric morbidity has been reported in one-quarter of women attending hospital for investigation of UI.
The cost to the NHS is significant: “this would approximate to gbp1.8bn annually in England and Wales, or perhaps gbp600 per incontinent individual.”
Lifestyle approaches excluded
The review specifically excluded an assessment of lifestyle and physical management approaches such as Pelvic Floor Muscle Training despite intensive lobbying at all stages of the process from the initial scoping document to the final draft. For example:
“The draft recommends Supervised Pelvic Floor Muscle Training but makes no mention of the only clinically proven pelvic toning device available on the Drug Tariff. In the published clinical trial the PelvicToner™ was shown to offer considerable benefits over traditional SPFMT especially in terms of more confident identification and isolation of the pubococcygeal muscle and improved compliance.”
“Thank you for your comment. This area falls outside the scope of the guideline update. Therefore, we could not provide a response. Details of your comment are held on file and may be considered as part of the scope of further updates of this guideline.”
However, in a summary of research the review notes that intensive Pelvic Floor Muscle Training is more effective than the standard recommended by previous NICE Guidelines:
“the rate of subjective cure or improvement was significantly higher in the intensive group in the study that considered this outcome (96% versus 66%)
But the Guidelines still hold to the recommendations of the 2006 Clinical Guidelines (CG40)
“• Offer a trial of supervised pelvic floor muscle training of at least 3 months’ duration as first-line treatment to women with stress or mixed UI.
• Pelvic floor muscle training programmes should comprise at least 8 contractions performed 3 times per day.”
This approach has no real clinical justification and it totally ignores the largest clinical trial in the field that demonstrated an objective cure in 85% in two weeks when women followed an intensive and rigorous pelvic floor exercise regime!
The Kegel Legacy
This whole issue is the subject of a new book that claims that a core treatment recommended by the NHS is not fit for purpose leading to a shocking waste of scarce resources and failing millions of women who then suffer a lifetime of discomfort, frustration and embarrassment.
The Kegel Legacy (ebook gbp1.99, paperback gbp 6.99) calls for a fundamental review of post-natal rehabilitation and care quoting clinical studies showing that at least 5000 new mothers every week are developing serious health problems because of the inadequate and ineffective care and advice being offered by the NHS. These new mothers are joining millions of women who are already suffering long term problems in one of the biggest health scandals of the 21st Century .
According to author Barry Fowler, the problem has arisen because the medical profession has ignored the one large scale clinical trial that established a Gold Standard for the treatment of the most common post-natal conditions caused by weak and damaged pelvic floor muscles - conditions such as stress incontinence, prolapse and poor sex - that make life a misery for between a third and a half of all women of all ages.
Barry Fowler cannot hide his frustration that mothers are not getting good, timely advice and the treatment they deserve. He finds it impossible to believe that a treatment that was clinically proven to cure 85% of problems in two weeks could be just ignored:
“Women are told to do their ‘Kegel exercises’ but the techniques recommended by doctors, physiotherapists and the media are not fit for purpose because they are simply not rigorous enough and fall far short of the clinically proven exercises recommended by Arnold Kegel. They fail to follow his key principles in every respect.”
To prove the point he emphasises the stark evidence: “If the exercises you are told to do by your doctor or physiotherapist were at all effective then we would not have 7 million women in the UK with stress incontinence, millions suffering prolapse and a multi-billion industry supplying designer incontinence pads. Millions of women are wasting their time for many months with ‘exercises’ that will never deliver any real improvement.”
“Instead of effectively promoting a simple, lifestyle management approach, successive NICE Guidelines have failed to adequately acknowledge the one solution that addresses the problem. Instead, huge sums are being wasted on surgery and pharmaceutical intervention that are often unnecessary and largely ineffective at curing the root cause of the problem. It is impossible to put a cost on the impact that this is having on the lives of millions of women. And on the waste of resources and budgets.”
The Kegel Legacy highlights sources showing that that most women are totally unprepared for the distressing health consequences of childbirth caused by pelvic floor weakness and damage ie stress incontinence, prolapse and poor sex, and unaware that simple and effective treatments are available. They are also unaware that the problems may not always be immediately obvious and that, without treatment, they can, and often do, become much worse on reaching the menopause.
The Kegel Legacy reviews the clinical research and the development of treatments over the years, and tracks the history of ‘Kegel’ exercises from when they were eventually adopted, 30 years after the original clinical trials. The medical profession of the day paid lip service to the original clinical studies and adopted an unproductive set of exercises for purely arbitrary reasons. Nothing has changed over time and there has been no attempt to develop the exercises in the light of new technologies and experience, nor to test the efficacy of the current methods against the original Gold Standard. As a consequence, on the rare occasions when women are actually taught to use the NICE recommended treatment, the results are poor, compliance is low and most women give up in frustration.
The Kegel Legacy guides the reader towards simple, effective and non-invasive treatment options to treat the major problems and is intended to stimulate an informed debate on the whole subject of post-natal care that will hopefully lead to a more effective and pro-active approach to post-natal pelvic floor rehabilitation and the better use of lifestyle management approaches as alternatives to pharmaceutical and surgical intervention.