Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
研究概览
简要总结
Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.
Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.
All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.
Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.
The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.
详细描述
- OBJECTIVES
To assess the effectiveness of self-management interventions in men with uncomplicated LUTS. 2. STUDY DESIGN
2.1 This is a randomised controlled trial comparing self-management with standard therapy. These interventions are proposed to optimise watchful waiting, providing an alternative to drugs and surgery for symptom control.
Participants
2.2. Participating urological units include the Middlesex Hospital NHS Trust and the Whittington Hospital NHS Trust.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •new patients with uncomplicated LUTS (I-PSS score 0-35)
- •aged 40 years and over
- •referred for the first time by their family doctor (general practitioner) to one of a participating urological outpatient departments
排除标准
- •lower urinary tract symptoms due to any urological malignancy
- •previous prostatic surgery within the last 10 years or pelvic radiotherapy
- •complications of urinary obstruction (acute or chronic urinary retention - post micturition volumes over 300ml, bladder stones, renal failure, recurrent urinary tract infection or haematuria)
- •uncontrolled diabetes, dementia and end stage cardiac or respiratory failure
- •inability to speak or understand the English language
- •severe symptoms where drug therapy or surgical management is indicated or requested by the patient
- •medical therapy for lower urinary tract symptoms in the previous 3 months, including alpha-blockers, 5-alpha reductase inhibitors (finasteride) or anti-cholinergics.
结局指标
主要结局
treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
次要结局
- infection
- quality of life / bother assessment (BPH Impact Index)
- Short Form-36
- Illness Perception Questionnaire - IPQ
- health-seeking behaviour (unscheduled clinic, A&E or GP visits)
- 3 day frequency / volume chart