A Single-blind, Multi-centre, Randomised, Controlled, Non-inferiority, Clinical Study to Assess the Safety and Performance of the Neurotech Vital Compact Device Compared to the Itouch Sure Pelvic Floor Exerciser for the Treatment of Stress Urinary Incontinence in Female Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 24
- 主要终点
- Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.
研究概览
简要总结
A prospective, randomised, controlled, single-blind, multi-site clinical study employing Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress urinary incontinence.
Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary incontinence will be enrolled in this study. All patients who are considered eligible to participate in the clinical study and give consent will be randomised to complete either a 12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will be completed by the subjects at home with treatment with the device in accordance with the device Instructions for Use.
详细描述
This is a prospective, randomised, controlled, single-blind, multi-site clinical study to be conducted in the United States of America (USA) employing Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress urinary incontinence.
Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary incontinence will be enrolled in this study. All patients who are considered eligible to participate in the clinical study and give consent will be randomised to complete either a 12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will be completed by the subjects at home with treatment with the device in accordance with the device Instructions for Use.
Subjects included in the clinical study will be evaluated at screening, on enrolment into the study (baseline) and during the 12-week treatment programme at 4 and 12 weeks. A telephone call will be made at 1 week to check on the patient's progress. In addition, subjects will be evaluated at 26 week following their commencement of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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, and not more than 65 years of age.
- •Subjects who have signed the informed consent form prior to any study related activity.
- •Subjects who have previously tried and failed to improve their condition using Kegel exercises.
- •Subjects who have been clinically diagnosed with stress urinary incontinence and demonstrate a greater than or equal to 3g urine leakage and a less than or equal to 90g urine leakage (>3g and < 90g) following a bladder-filling protocol and then a standardised stress test (provocative pad weight test) at the baseline assessment.
- •Subjects who score 9 or less (<9) out of 18 for the Urge 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 ≤ 35 kg/m
- •Subjects of child-bearing potential who are using a highly effective contraceptive method (established use of oral, injected, implanted hormonal method of contraception or barrier method of contraception with spermicide).
- •Subjects who are willing not to seek any other treatment for stress incontinence during the study period.
- •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, e.g. reduced sensory perception in the contact area of the stimulation electrodes; scars or vaginal tissue wounds, lesions or inflamed/infected areas in the contact area of the stimulation electrodes; vaginal bleeding between menstrual periods; uncontrolled diabetes.
- •Subjects who have a physical condition that would make them unable to perform the study procedures, e.g. pelvic or hip surgery within the past 6 weeks.
- •Subjects who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- •Subjects with a history of an underlying neurological condition, e.g. Multiple Sclerosis, Parkinson's disease, epilepsy.
- •Subjects with any bladder abnormality that would affect the urinary flow through the lower urinary tract including signs or symptoms of an active urinary tract infection, abnormal bladder capacity (e.g., >300 cc), post void residual volume >200 cc, spastic bladder, vesico-ureteral reflux or bladder stones.
- •Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
- •Subjects who have previously had any uro-gynaecological related surgery that would affect the pelvic floor muscles or urinary flow through the urethra (excluding hysterectomy).
- •Subjects who have previously had pelvic floor radiation.
- •Subjects who have previously been treated for stress incontinence with injectable bulking agents and/or vaginal probes within the past 6 months.
- •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 conductive 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, insulin pump etc.) or conditions that may be adversely affected by electrical stimulation (e.g. cardiac arrhythmias).
- •Subjects with a current or active history of pelvic cancer and/or subjects with a life expectancy of less than 12 months.
- •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.
研究组 & 干预措施
Neurotech Vital Compact
The Neurotech Vital Compact will be used by subjects with Stress Urinary Incontinence 5 days per week for 30 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.
干预措施: Neurotech Vital Compact (Device)
itouch Sure Pelvic Floor Exerciser
The itouch Sure Pelvic Floor Exerciser will be used by subjects with Stress Urinary Incontinence 7 days per week for 20 minutes per session for 12 weeks followed by 14 weeks of Kegel exercises.
干预措施: itouch Sure Pelvic Floor Exerciser (Device)
结局指标
主要结局
Proportion of subjects who have achieved >50% improvement on the provocative pad weight test.
时间窗: 12 weeks
Subjects will complete an in-office 1 hour provocative pad test to determine volume of urine leaked during the test.
次要结局
- Within group comparison of mean change in urine leakage in the 1 hour pad weight test(12 weeks)
- Between group comparison of the proportion of subjects achieving dryness at Week 12 (<1g on the provocative pad weight test)(12 weeks)
- Between group comparison of mean change in urine leakage in a provocative pad weight test(12 Weeks)
- Between group mean change in urine leakage in the 24-hour pad weight test(12 weeks)
- Within Neurotech Vital Compact group estimate of mean change in the number of pads used/day(12 weeks)
- Within Neurotech Vital Compact group estimate of mean improvement in Incontinence Quality of Life Questionnaire (I-QOL) score(12 weeks)
- Comparison of adverse events(6 months)
- Between group comparison of the mean improvement in the Incontinence Quality of Life Questionnaire (I-QOL) score(12 weeks)
- Between group comparison of the proportion of subjects achieving dryness(12 weeks)
- Between group comparison of mean change in the number of incontinence episodes per day.(12 weeks)
- Within Neurotech Vital Compact group estimate of mean change in urine leakage in the 24-hour pad weight(12 weeks)
- Between group comparison of mean change in the number of pads used/day(12 weeks)