The PelvicToner proves superiority over the 'Gold Standard'
The study confirmed that using the PelvicToner without supervision is as effective as the NICE Gold Standard of supervised pelvic floor muscle training.
The Bristol Urological Institute clinical study
Following the successful US trial, a randomised controlled study of the PelvicToner was started at The Bristol Urological Institute, the UK's leading urodynamics research institute in 2008. The aim of the study was to directly compare the PelvicToner with the current NHS 'Gold Standard' treatment of pelvic floor muscle training (PFMT), the only other course of treatment recommended by NICE (CG40).
Clinical research published in the British Medical Journal recommended that pelvic floor exercise should be the first choice of treatment for genuine stress incontinence because simple exercises proved to be far more effective than electro-stimulation or vaginal cones.
Or, in less technical speak. self-treatment in the privacy of your own home using a simple, low-cost device was as effective a treatment for a weak pelvic floor as a three month course of pelvic floor muscle training supervised by a specialist physiotherapist costing £100s.
A unique achievement
In all other comparative studies the only other conservative forms of treatment ie vaginal weights (Aquaflex) and TENS or electro-stimulation devices have consistently proved to be inferior to the Gold Standard.
There are no published trials that justify the issuance or effectiveness of a leaflet describing pelvic floor exercises that is the best that the patients of 62% of GP practices can hope for (recent survey).
To download the full paper in pdf form click here.
About the study
At the commencement of the trial in 2008 Paul Abrams the Professor of Urology at BUI had 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.”
This optimism was well founded.
The report author, Professor Marcus Drake, notes how the use of the PelvicToner can help overcome the fundamental weaknesses associated with PFMT ie poor training, lack of patient confidence and poor compliance with the exercise recommendations.
Key points noted by the research are that:
- the PelvicToner gives “confidence to women that they were correctly contracting their pelvic floor, and this may be helpful encouragement when a woman is starting out on a regime of PFMT.”
- the biofeedback given by the PelvicToner “may be particularly helpful to demonstrate to the woman that she is carrying out the PFME appropriately.”
- the PelvicToner is particularly relevant to those women “who do not consult their physician and wish to maintain confidentiality regarding their SUI symptom.”
The findings of the trial have been presented at national and international conferences including the ICS Conference, San Francisco, September 2009.
In January 2011 the PelvicToner was listed within the Drug Tariff Part IXA-Appliances in the new category of Pelvic Toning Devices.
How it works
The PelvicToner works on the basis of the key principles identified by Arnold Kegel, and helps the user identify and isolate the correct muscles and then exercise by squeezing against resistance. The user gets instant feedback to show they are squeezing correctly and, as the user improves, she can increase the resistance in stages to make your exercise more demanding. It's so simple to use and takes just five minutes a day.
A fair comparison
The PelvicToner exercise regime, as recommended, is significantly more demanding and more effective than traditional PFMT which recommends just a daily total of 10 x fast pull-ups and 10x slow pull-ups. Users of the PelvicToner are recommended to start with three sets of ten repetitions at the lowest resistance building to three sets of 50 or more based on personal ambition and ability. Users start with the lowest level of resistance but can build swiftly through 5 progressive levels. Kegel viewed the use of a progressive resistance, increasing in line with ability, as fundamental. He also recommended a minimum of 300 squeezes per session. The current NHS teaching methods do Kegel a total disservice by associating his name with a totally watered-down version of his exercises! The bastardisation of Kegel's recommendations has been the subject of some debate within the medical profession worldwide.
In the clinical trial the aim was to compare the two methods on a level playing field so the users of the PelvicToner were restricted to a daily total of 10 x fast pull-ups and 10x slow pull-ups at the lowest resistance. Even on this basis the research concluded:
“the PelvicToner Device (PTD) is not inferior to standard treatment, is safe and well tolerated, and increases patient choice. The PTD helped to isolate and focus on contracting the correct muscles, motivating (patients) to continue exercising."
The consultant, Mr Marcus Drake points out that treatment, such as electro-stimulation and vaginal weights or cones, have been deemed as ‘inferior’ in clinical trials. This leads to the obvious conclusion that the PelvicToner is therefore superior to the use of electro-stimulation and vaginal weights or cones.
Several papers by nurses and physiotherapists have identified that the traditional PFMT methods fail because: "Pelvic floor exercises are often poorly taught and ineffectively carried out, patients often fail to engage the correct muscles and fail to continue with the exercises as prescribed." Some clinical studies report that as many as 30% of women are unable to identify and squeeze their pelvic floor muscle when asked.
All of these weaknesses in the current approach are directly overcome with the PelvicToner. Perhaps the greatest benefit is that women are much more likely to continue with the exercises if they experience a very rapid improvement in their symptoms. With traditional PFMT they are advised to exercise for three months and many physiotherapists do not expect to see an improvement any sooner than this. In the absence of progress many women just give up.
It could have been better!
The PelvicToner was not tested in use according to the manufacturer's instructions and therefore the results significantly understated the benefits, not least the key fact that over 85% of users become more aware of their pelvic floor within a week and experience resolution of their symptoms within 4 weeks. Two factors that significantly influence compliance with the exercise regime when compared to supervised PFMT.
Download the full report
Click on the link below to download the full trial document: