Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence

Study Overview
=================
Brief 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: 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). 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.

Official 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

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Active Neurotech Vital
* Device: Modified Neurotech Vital Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are female and at least 18 years of age. Subjects who have signed informed consent form prior to any study related activity. Subjects who have previously failed a 6 week volitional pelvic floor muscle training programme or in the Investigators opinion an equivalent lifestyle and exercise programme. Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a >4g urine leakage following a standardised 1-minute stress test at 1 hour post-bladder filling protocol (1-hour pad weight test). Stress urinary incontinence is defined as complaint of involuntary leakage on effort or exertion, or on sneezing and coughing' (International Continence Society). Subjects who have scored at least 18 out of 27 for the Stress Incontinence Questions and are confirmed as having predominant stress urinary incontinence on the Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment. Subjects with a Body Mass Index of ≤ 40 kg/m2 Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained. Subjects who are able to understand this study and are willing to complete all the study assessments. Exclusion Criteria: Subjects who have an existing medical condition that would compromise their participation in the study. Subjects who have a physical condition that would make them unable to perform the study procedures. Subjects who have any respiratory condition including a chronic cough or history of same. Subjects with a history of an underlying neurological condition. Subjects with a history of low back pain involving the spinal nerve root. Subjects who are currently taking medication, or have taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergics or anti-histamines or any anti-anxiety medications. Subjects with a blood clotting disorder or who are taking anti-coagulant medications. Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy. Subjects with a clinical diagnosis of prolapse greater than Stage 2. Subjects who are pregnant or could be pregnant. Subjects who are less than 6 months post-partum or who are lactating. Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine. Subjects with pelvic pain or fibromyalgia or paravaginal defect. Subjects with an active implanted medical device (i.e. pacemaker, pump etc). Subjects with a history of heart disease or stroke. Subjects with a known cancer. Subjects with an injury or disability affecting any part of their body which will be in contact with the garment. Subjects who are currently involved in any injury litigation claims. Subjects who have participated in a clinical study in the last 3 months or any previous clinical study with Bio-Medical Research Ltd. Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority. Any vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical and medical device industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Neurotech Vital Device<br>50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks. | Device: Active Neurotech Vital<br>* 12 weeks treatment for 30 minutes per day, 5 days out of 7.<br>|
| Placebo Comparator: Modified Neurotech Vital Device<br>50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks. | Device: Modified Neurotech Vital Device<br>* 12 weeks treatment for 30 minutes per day for 5 days out of 7.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All participants taking part in a standardised 1-minute stress test | We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement. | 12 weeks | 
| All participants to complete a Quality of life questionnaire (I-QOL) | We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| participants taking part in a 1 minute stress test | We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule. | 4, 8, 12 and 26 weeks | 
| participants taking part in a 1-hour pad weight test | The loss of urine in grams after this test at the above time points will be collected and using the definition of dryness (pad weight of less than 1 gram) they will be looked at to see if at any of the above timepoints the participants are classed as dry i.e. have urine loss of less than 1gram following the stres test. | Stress test done at 4, 8 and 12 weeks during treatment with the device and at 6 months, for the main and cohort part of study | 
| particpants taking part in the stress test and then having the pad weight to show loss of urine. | We are looking at a significant reduction in the weight of the pad after the stress test has taken place, this improvement is defined as a greater than 50% reduction in pad weight in all particpants who took the test at baseline compared to the weight of the pad at 4, 8 and 12 weeks and at 6months for the main and cohort studies. | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 1-hour pad weight test | reduction in pad weight on the 1-hour pad weight test in relation to the mean intensity of the stimulation delivered during the 12-week treatment programme; | 4, 8 and 12 weeks and at 6 months, for main and cohort part of the study | 
| quality of life questionnaire | quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL) (except for the 12 week assessment which is one of the primary endpoints); | 4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study | 
| quality of life questionnaire | quality of life questionnaire assessed using the Kings Health Questionnaire (KHQ) | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 24 hour pad weight test | urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test); | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 24 hour pad weight test | dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test; | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 24hour pad weight test | significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24-hour pad weight test; | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 3-day diary card | number of incontinence episodes/day recorded using a 3-day voiding diary; | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| 3-day voiding diary | number of pads used/day recorded using a 3-day voiding diary; | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| Modified Oxford Score | pelvic floor strength and quality of contraction measured using the Modified Oxford Score; | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| Pelvic floor ultrasound | pelvic floor muscle function measured using sonographic/real time ultrasound imaging/recording with displacement measurement using on screen callipers on the sonogram unit to assess volitional contractions | 4, 8 and 12 weeks and at 6 months for main and cohort part of the study | 
| participants taking part in a 1 minute stress test | We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule. | We will compare the urine loss against the urine loss after 4weeks treatment with the device and also after 8weeks treatment with the device and 12 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress urinary Incontinence, SUI, Continence