The Femeda team are committed to developing evidence based treatments. We have worked in partnership with Professor Jackie Oldham at Manchester University to put the new product through clinical trials at the Wellcome Trust Research facility in Manchester.
The product was developed using the working name ‘Femestim’. The study was designed
as a pragmatic randomised controlled trial. A total of 123 women consented to take
part in the study. The control group performed unsupervised pelvic floor exercises
daily and the active group used the ‘Femestim’ product and performed unsupervised
pelvic floor exercises daily for 12 weeks. The outcome measures were the ICIQ UI,
the ICIQ-
The results of this research were presented to the International Continence Society meeting in2010.
Following the Manchester study the Femeda team have added a few improvements to the
Femestim device and it is now ready to be launched to the UK market under its new
name ‘Pelviva’. Our market research has lead us to take a very positive approach
to this subject area. Previous sales campaigns for products in this sector have avoided
the real issues affecting women – inventing terms such as ‘Light adult incontinence’
and ‘sensitive bladder’. The word ‘Pelviva’-
It is anticipated that ‘Pelviva’ will be a valuable aid to clinicians working in pelvic floor muscle rehabilitation; enabling women to be able to improve the function of their pelvic floor muscles in a way that can easily fit into their lifestyle.
Summary Highlights
Femestim plus exercise produced significantly better outcome when compared to unsupervised
exercise alone. This amounted to 50% improvement for the Femestim group compared
to 25% for the exercise alone group in terms of overall ICIQ-
In terms of sexual activity it was apparent that in the majority of women their
incontinence did not spoil or cause discomfort during sex. Women did however describe
their incontinence as bothersome during sex. This improved for both groups though
to a statistically significantly (p=0.026) greater extent in the Femestim group.
Both groups of women described a reduction in severity of symptoms post treatment (p<0.000) though on average the number of women describing their condition as mild or normal post treatment was greater for the stimulation group (84.3%) than for the exercise only group (69.6%). Both groups described a similar degree of exercise participation (p>0.05) varying from nothing to three times daily. Women generally were enthusiastic about using the Femestim device, found it easy and comfortable to use and described moderate to strong contraction of the pelvic floor.
Reducing female bladder weakness
Healthcare
Professionals
