UK Clinical research

There is total consensus in all the research and reviews on the treatment of Urinary Stress Incontinence in women that pelvic floor exercises are the best first line treatment and NICE CG40 recommends there use in primary care. However, even the physiotherapist supervised pelvic floor muscle training recommended by NICE falls short of the results originally achieved by Arnold Kegel. The PelvicToner is a progressive resistance vaginal exerciser designed to comply with all of Kegel's principles and can demonstrate much greater effectiveness and more rapid improvement than the treatment currently offered.

Clinical research published in the British Medical Journal showed that pelvic floor exercises are far more effective than electro-stimulation or vaginal cones. These options are not recommended in NICE CG40.

The Bristol Urological Institute clinical study

Following an initial study in the US, a second study was started at the UK's leading urodynamics research institute in 2008 with the objective of directly comparing the PelvicToner with the current NHS 'Gold Standard' ie pelvic floor muscle training (PFMT) as recommended by NICE.

The first phase of the study concluded in late 2009 and the results were published in the British Journal of Urology International in January 2010 and confirm that using the PelvicToner without supervision is as effective as the NICE Gold Standard of supervised pelvic floor muscle training.

The trial published in the BJUI established non-inferiority of the PelvicToner compared to a three month course of supervised pelvic floor muscle training - the only other course of treatment recommended under NICE CG40. 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).

The basis of the comparison is explored below - The PelvicToner superiority over the 'Gold Standard'

To download the full paper in pdf form click here.

Everything Kegel envisaged

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.

Significant cost-benefits to the NHS

The cost-benefit justification for the PelvicToner was presented to NHS Prescription Services based on data provided in NICE CG40 Full Guidelines which, at the time of the exercise, were 7 years out of date.

The NICE Guideline does not add a cost for primary care and the assumption was made that the cost of an initial GP consultation with a referral or prescription carries no cost.

The PelvicToner provided on prescription offers the equivalent treatment to supervised PFMT plus biofeedback at a cost of £15.00 plus any administration charges associated with the administration of the prescription service itself.

Urodynamics training is costed by NICE (2004 figures) at £140.00.

Pelvic Floor Muscle Training alone is costed at £131.00 on average and up to £168.00.

Pelvic Floor Muscle Training with Biofeedback is costed at £166.00 It is this latter option that most closely equates to PelvicToner use.

These figures suggest a cost-benefit ratio in excess of 13:1 based on 2004 figures raising the obvious question: Should the PelvicToner be provided automatically to every woman presenting with symptoms of SUI so that the subsequent reduction in demand for specialist physiotherapy services and surgical intervention can be focussed on the most needy.

The PelvicToner superiority over the 'Gold Standard'

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.

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.

The US study

An initial trial in the US measured the physical improvement in muscle strength when resting and 'clenching' the pelvic floor. 20 female patients with incontinence, bladder dysfunction and/or sexual dysfunction related to pelvic floor relaxation participated in a 16 week trial.

The PelvicToner exercise program was taught and surveys were completed initially and at 8 weeks and study completion at 16 weeks.

Pelvic tone pressure measurements at rest and during voluntary contraction effort were taken initially, and at 3, 8 and 16 weeks. 15 subjects completed the full course. Subjective improvement was noted by 73% of study subjects. In the entire group overall mean resting pelvic muscle tone improved by 9.6%, while mean Kegel strength increased by 28%. In the 7 of 15 subjects with improved resting tone, the mean increase was 38%. Thirteen of fifteen subjects (87%) had improved Kegel strength. Average pelvic tone measurements were increased at 3 weeks and continued to increase at 8 and 16 weeks.

Subjective data collected by surveys revealed overall improvement in sexual satisfaction, bladder function and satisfaction with the program and use of the device. Thirteen (87%) of the participants indicated that they would continue the program and using the device on an ongoing basis.

The page below is reprinted from the Autumn 2007 BioMed Newsletter when the BUI trial was announced. It puts the research into a useful context.