Neurotech Vital RCT - BMR-11-1002
Research type
Research Study
Full title
A randomised, controlled, double-blind, clinical study to evaluate the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device for the treatment of stress urinary incontinence.
IRAS ID
136737
Contact name
Julie Rowbotham
Contact email
Sponsor organisation
Bio-Medical Research Ltd
ISRCTN Number
ISRCTN68358784
Research summary
Stress Urinary Incontinence is described as an uncontrolled loss of urine which happens when physical activities such as running, jumping and lifting etc are carried out or when increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.
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 Neurotech Vital device with an altered Neurotech Vital device that does not give the same stimulation treatment. There is a 50% chance of you receiving the altered device, if you do, you will be offered the non-altered Neurotech vital device after your first 12 week treatment programme. Both devices are identical in looks, but give different stimulations through the skin contact electrodes.
The study involves wearing a device that includes a wired garment around the hip and bottom area for a period of 30 minutes, 5 days out of 7, for 12 weeks. During this treatment, 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 failed a 6 week exercise programme and have been diagnosed with Stress Urinary Incontinence. It will take place at hospital uro-gynaecology clinics/continence clinics across the United Kingdom. The study could last up to 16 months.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
13/YH/0318
Date of REC Opinion
7 Oct 2013
REC opinion
Further Information Favourable Opinion