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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- All participants to complete a Quality of life questionnaire (I-QOL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
All participants to complete a Quality of life questionnaire (I-QOL)
时间窗: 12 weeks
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.
All participants taking part in a standardised 1-minute stress test
时间窗: 12 weeks
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.
次要结局
- participants taking part in a 1-hour pad weight 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)
- quality of life questionnaire(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- Pelvic floor ultrasound(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- particpants taking part in the stress test and then having the pad weight to show loss of urine.(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- Modified Oxford Score(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 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)
- 1-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(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- 3-day diary card(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- 3-day voiding diary(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)
- 24 hour pad weight test(4, 8 and 12 weeks and at 6 months for main and cohort part of the study)