Evaluation of a new technology for treatment of bladder leakage v1.0
Research type
Research Study
Full title
Primary Care Evaluation of a Novel Disposable Neuromuscular Electrical Stimulation Treatment for Female Urinary Incontinence: A Randomised Controlled Trial
IRAS ID
223014
Contact name
Jacqueline Oldham
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN13500331
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Urinary incontinence affects as many as one in three women and can have a considerable impact on quality of life. Commonly women experience leakage of urine during activities with increased intra abdominal pressure such as physical exertion, coughing, or sneezing, which is known as urinary stress incontinence. However, some are affected by urgency, frequency or being woken at night to pass urine and can have episodes of urgency urinary incontinence. Some women also experience mixed incontinence. Femeda, a UK-based company and scientists at the University of Manchester have now developed a disposable neuromuscular electrostimulation device known as Pelviva with an innovative stimulation pattern that is capable of creating a contraction of the pelvic floor muscles when inserted like a tampon in the vagina. A previous study has demonstrated the efficacy of the Pelviva device for the treatment of urinary incontinence in women (Oldham, Herbert & McBride 2013). The study demonstrated that Pelviva is a successful device for the treatment of urinary incontinence when combined with unsupervised pelvic floor muscle exercise and produces statistically significant superior results to unsupervised pelvic floor muscle exercise alone. Furthermore, there are no apparent adverse incidents associated with using the device. The device is generally easy and comfortable to use and enables women to manage their incontinence in the privacy of their own home. The Pelviva device has undergone further development and modification since the 2013 trial report and this study addresses previous limitations in evaluating the final commercialisable product.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0395
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion