A single blind, randomised UK pilot study
Research type
Research Study
Full title
A randomised, controlled, single blind, pilot clinical study to evaluate the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device compared to the itouch Sure Pelvic Floor Exerciser for the treatment of stress urinary incontinence in female patients.
IRAS ID
151261
Contact name
Paul Ballard
Contact email
Sponsor organisation
Bio-Medical Research Ltd
Research summary
Stress Urinary Incontinence is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting are carried out.
There are various treatment options available - surgical operations, pelvic floor exercises/muscle training and electrical stimulation. This study aims to prove that using the Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and tone them and in doing so improving stress urinary incontinence.
We are comparing the device to a vaginal probe device which is CE marked and on the market for use in the UK.The Neurotech Vital and the vaginal probe both use electrical muscular stimulation to stimulate the pelvic floor muscles, however the probe is placed inside the vagina to stimulate the muscles and the Neurotech Vital device has external electrodes which are wrapped around the upper thigh and buttocks and stimulate the muscles.
The study involves wearing the Neurotech Vital for a period of 20 minutes, 5 days out of 7, for 12 weeks or using the vaginal probe for 20 minutes, 7 days a week for 12 weeks according to the manufacturers instructions. During the treatment with the Neurotech Vital, electrical stimulation is passed through skin contact electrodes (large sticky black pads) which causes the pelvic floor to contract and relax, without you having to do anything. This treatment is not painful and is very similar to the workout you would get from relaxing and contracting your pelvic floor muscles yourself, however the device produces a much stronger contraction.
The study is open to females who have been diagnosed with Stress Urinary Incontinence. It will take place at one hospital in the United Kingdom. The study could last up to 18 months.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/0083
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion