The Bristol Urological Institute clinical study
Following the 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 '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 and confirm that using the
PelvicToner without supervision is as effective as the NICE Gold Standard of
supervised pelvic floor muscle training. 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 following page is reprinted from the Autumn 2007 BioMed
Newsletter when the BUI trial was announced. It puts the research into a
useful context.