Wellcome Trust Clinical Study – Pelviva® Shows Proven Efficacy

Wellcome Trust Clinical Study – Pelviva® Shows Proven Efficacy

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How women manage poor bladder control associated with urinary incontinence varies immensely. In our market research we identified that some women are avid pelvic floor exercisers managing to effectively maintain their pelvic floor muscles, to prevent bladder leaks occurring. Yet others use methods that only cope with what they see as the inevitable. However, just making-do with a condition that can severely impact quality of life, may lead to anxiety, depression, and social isolation.1,2

Showing the efficacy of Pelviva® in retraining pelvic floor muscles to help regain bladder control has been at the core of the clinical development programme at Femeda.  A clinical study lead by Professor Jackie Oldham and a team at the Wellcome Trust Clinical Research Centre in Manchester, undertook a 12-week randomised single blinded pre-post-test evaluation of Pelviva® verses unsupervised pelvic floor exercises with 123 women.3

Pelviva® is a unique single use intra-vaginal medical device that uses reactive pulse technology to effectively exercise, strengthen and re-train the pelvic floor muscle fibres. The device is used every alternative day for 30 minutes over a 12-week period. Each Pelviva® delivers a unique intensive reactive pulse to stimulate the pelvic floor muscles. During the 30-minute treatment Pelviva’s reactive pulse technology provides constant feedback to ensure the right therapeutic level of muscle stimulation is maintained.4

In the 12-week study, 84% of women using Pelviva® reported improved bladder control finding the device easy and comfortable to use. When compared to women doing their own pelvic floor muscle exercises, women using Pelviva® experienced a four times greater reduction on the impact that bladder leaks had on their lives.3

Overall, women using Pelviva® alongside unsupervised pelvic floor exercises, experienced statistically significant superior results to unsupervised pelvic floor muscle exercise alone. Furthermore, there were no apparent adverse incidents associated with using the device, which women found easy and comfortable to use in the privacy of their own home.3

Pelviva® will be launched in the UK in Quarter 2 of 2018.

References

  1. Harriet Vogt Research & Planning May 2015.
  2. Sinclair, A. J. and Ramsay, I. N. (2011), The psychosocial impact of urinary incontinence in women. The Obstetrician & Gynaecologist, 13: 143–148. doi:10.1576/toag.13.3.143.27665.
  3. Oldham J, Herbert J, McBride K. Evaluation of a new disposable “tampon like” electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: a 12-week single blind randomized controlled trial.Neurourol Urodyn. 2013 Jun;32(5):460-6. doi: 10.1002/nau.22326.
    Femeda Data on File 2014.