Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Condition specific quality of life
研究概览
简要总结
Evaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.
详细描述
This United Kingdom study will comprise a single blind, primary care, post-market evaluation of a novel neuromuscular electrical stimulation treatment for urinary incontinence . Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two groups (intervention or control). The control group will receive routine care via their GP practice. The intervention group will receive the electrical stimulation device. Treatment will last for 12 weeks with a Quality of Life (QoL) primary end point immediately post treatment with a second phase to explore the impact of a further 12 weeks maintenance programme in the intervention group compared to routine care. There will be a further two year follow-up assessment.
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
- Triple (Care Provider, Investigator, 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
- 是
入选标准
- •Aged between 18 and 65
- •GP determined urinary incontinence
排除标准
- •Abnormal abdominal mass
- •Clinical history of urinary retention problems
- •Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia
- •Pregnancy or given birth within the last three months
- •Implanted pacemaker
- •Recent pelvic surgery (within the last 12 months)
- •Recent haemorrhage, haematoma and/or tissue damage to the vagina
- •Undergoing any active therapy or review appointments for pelvic malignancy
- •Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
- •Manual dexterity insufficient to place the electrical stimulation device in the vagina
- •Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease
- •Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
- •Insufficient cognitive ability to provide informed consent and/or participate in the study
- •Unwillingness to participate in the study
结局指标
主要结局
Condition specific quality of life
时间窗: 12 weeks
The primary outcome measure is Quality of Life measured through self-completion of the short form version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI). The Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on urinary incontinence in research and clinical practice across the world. Scoring \& analysis: Question items include: frequency of urinary incontinence, amount of leakage and leak interference. The overall score is calculated from the sum of: Leak frequency (minimum 0, maximum 5) Leak amount (minimum 0, maximum 6) Leak interference (minimum 0, maximum 10) Overall score is therefore between 0-21 - the higher the score the worse the outcome
次要结局
- Female Sexual Function Index (FSFI)(12 weeks)
- Sexual dysfunction questionnaire(12 weeks)
- Patient Global Impression of Severity and of Improvement(12 weeks)
- 1-hour in-clinic provocative pad weight test(12 weeks)
- User experience Diaries(12 weeks)
研究者
Jackie Oldham
Professor Jackie Oldham
University of Manchester