Clinical 2018-01-05T16:10:35+00:00

Clinical Research

Demonstrating the clinical performance to our health professional customers is important to Femeda

Peer-Reviewed Publication

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.

Primary outcome:

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

Secondary outcome:

Using the patient global impression of severity and improvement (PGIS/PGII) scale 84% of women, using Pelviva reported improved bladder control

Summary:

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

Post-marketing surveillance

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.