Demonstrating the clinical performance to our health professional customers is important to Femeda
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.
Author: Oldham J, Herbert J, McBride K.
Publishers: Neurourology Urodynamics 2013 Jun;32(5):460-6.
A randomized single blinded pre-post test evaluation of Pelviva® versus unsupervised pelvic floor muscle exercises, was conducted by Wellcome Trust Research Centre, Manchester.
Using a condition specific quality of life questionnaire (ICIQ-UI) (clinical trial standard for category) women using Pelviva® for 12 weeks experienced a four times greater reduction in the impact that bladder leaks had on their lives when compared to women doing unsupervised Pelvic Floor muscle exercises
Using the patient global impression of severity and improvement (PGIS/PGII) scale 84% of women, using Pelviva reported improved bladder control
Pelviva plus unsupervised exercise produced a significant better outcome than unsupervised exercise alone.
Women found Pelviva comfortable, easy to use and experienced no adverse events
Femeda is committed to an enhanced post market clinical evaluation programme for Pelviva®.
Both a post market Clinical Study and a Longitudinal Human Factors Study are planned post launch in Quarter 2 2018. These are designed to deliver enhanced claims for professional marketing and public relations development.