Is the PelvicToner clinically proven?
It is essential to meet very strict levels of proven clinical efficacy before a product can be put on the Drug Tariff and made available on prescription. The clinical trials of the PelvicToner were conducted by one of the most highly regarded research institutes in the UK to a protocol that met the most demanding standards of clinical research of this nature. The sample size was robust and very significant for a study of this kind, and much larger than many other comparative studies in this field.
The trial results published in the British Journal of Urology International 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 Guidelines CG40. In the context of a clinical trial, non-inferiority is praise indeed. Treatments are assessed as inferior or not inferior. The word 'superiority' does not feature.
In comparative studies the other conservative forms of treatment, ie vaginal weights (Aquaflex) and TENS or electro-stimulation devices, have consistently proved to be inferior to supervised pelvic floor muscle training. This is well documented with papers published in the British Medical Journal and others. It is for this reason that these other conservative forms of treatment are not suggested in NICE Guidelines.
"Measures such as electrical stimulation, weighted vaginal cones and biofeedback ... are not universally advocated as they have yet to produce sufficient evidence of efficacy." Comment on current NICE recommendations extracted from BJUI article.
As the only treatment that is not inferior to PFMT, the PelvicToner is accurately judged to be superior to weights and electrical devices.
In very many respects the PelvicToner is superior to supervised pelvic floor muscle training. In the clinical trial the sole objective was deliberately to compare the Gold Standard treatment (a 3 month programme of supervised pelvic floor muscle training) with the PelvicToner on a level playing field. The PelvicToner was not tested in use according to the manufacturer's instructions and therefore the results significantly understated the benefits of using it, 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.
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. Arnold 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 PelvicToner is not specifically mentioned in the current NICE Guidelines because CG40 has not been reviewed since the PelvicToner was entered onto the Drug Tariff.