Clinical Research

Recent 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. 

Following the latest clinical trials it is true to say that the PelvicToner is therefore superior to the use of electro-stimulation and vaginal weights or cones.

Research in the US confirms that the PelvicToner exercise programme can play a major role in the treatment of stress incontinence symptoms and some physical aspects of sexual dysfunction. Subjects were monitored throughout a 16 week period. The pelvic tone pressure was measured at rest and during active voluntary contraction (Kegel strength or Kegel tone). 87% of subjects showed improved Kegel strength and amongst those achieving improved resting tone the mean increase in Kegel tone was 38%. Subjective data collected by surveys revealed an overall improvement in bladder function and sexual satisfaction, and high levels of user acceptance. 

User surveys in the UK have mirrored these findings with 87% of respondents reporting improved bladder control with 4 weeks and 80% reporting an improved sex life. 

The PelvicToner has been the subject of a full scale clinical trial to compare it with traditional Pelvic Floor Muscle Training (PFMT) at the Bristol Urological Institute, one of the UK's leading stress incontinence clinics and centre for urodynamics research.

The Bristol Urological Institute clinical study 
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 'gold standard' ie pelvic floor muscle exercises (PFME). 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. To download the full paper in pdf form click here.

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 PFME 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 PFME.” 
  • 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. 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 you exercise by squeezing against resistance. The user gets instant feedback to show you 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 PFME which recommend 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 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! 

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." 

In contrast, treatment using electro-stimulation or 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.

Click here for details.

For a summary of scientific papers related to non-surgical treatment of incontinence and pelvic floor exercises click here