NCT02214784

Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Atlantic Therapeutics · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stress Urinary Incontinence (SUI) 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.

Detailed description

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. This study is being carried out to further prove that the Neurotech Vital device is an effective way of treating stress urinary incontinence in female participants.The study will look at the results of a 12 week treatment programme with the Neurotech Vital device compared to the modified Neurotech Vital device. It will compare the following: 1. how much urine is lost in a standard 1 minute stress test carried out at the baseline visit (start of the treatment) right through to visit 5 (end of the treatment - 12 weeks). 2. How much improvement is shown in the quality of life questionnaire (this is measured by ticking questions which have scores attached to them and adding up the total score for the questionnaire). This questionnaire asks questions on quality of life which is affected by stress urinary incontinence.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Active Neurotech Vital	12 weeks treatment for 30 minutes per day, 5 days out of 7.
DEVICE	Modified Neurotech Vital Device	12 weeks treatment for 30 minutes per day for 5 days out of 7.

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-08-12
• Last updated: 2018-02-05

Locations

3 sites across 1 country: Germany