This is an extremely exciting development using a real world setting of a GP practice in Greater Manchester to conduct the next clinical evaluation of Pelviva. This study will be possible due to the development of an enhanced e Health research database using e Health records in Greater Manchester which is part of a new approach to healthcare research supported by MHRA, NIHR, and NICE. Femeda will be the first small / medium sized (SME) medical device business to take part in such research and will work in partnership with the Greater Manchester Clinical Research Network (GMCRN), Northwest e Health and the University of Manchester. The project will be led by Professor Jackie Oldham.
This study will comprise a randomised real world experimental medicine medtech evaluation of a novel neuromuscular electrical stimulation treatment for incontinence - Pelviva. Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two treatment groups.
- Pelviva vs usual GP care for female UI
- Treatment will last for twelve weeks
- Primary end point: post treatment quality of life questionnaire.
This study has been powered to detect a significant mean difference between groups in terms of quality of life immediately post treatment. Data from a previous reported study (Oldham, Herbert & McBride 2013) indicates that a two-sided test, with 0.05 level of significance and 90% power will require a sample size of 134 per group.
A total of 330 patients will be recruited allowing for an additional 20% for dropouts.
Primary outcome measure
ICIQ-UI SF - a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on QoL of urinary incontinence in research and clinical practice across the world.
Primary outcome measure
- Sexual dysfunction questionnaires (PISQ-IR and FSFI)
- Patient Global Impression of Severity and of Improvement (PGIS / PGII)
- 1 hour - in clinic pad weight test.
- Patient usability diaries (throughout the intervention to assess the user experience of ‘usual GP care’ and ‘Pelviva’).
Long term assessment
Every patient interaction with a healthcare provider produces data. The Northwest EHealth Electronic Healthcare Record (EHR) has led to the development of a Linked primary /secondary care Database System (LDS). This will give Femeda the opportunity to periodically interrogate trial patient data in the longer term.
It is intended that this study will enable Femeda to accurately identify detailed incontinence outcomes and utilisation costs in a real world situation.