Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Maximum urinary flow rate (Qmax)
研究概览
简要总结
Ageing and the availability of medication has led to an increase of elderly male patients being treated for lower urinary tract symptoms (LUTS), or voiding problems ("prostate problems"). However, guidelines are vague as to which patients should and which should not be treated, and how.
Although several treatment modalities have proven efficacy in selected populations, it is unclear how effective these treatments are in daily practice.
This study investigates the hypothesis that a treatment protocol in which clear indications are formulated for all treatment modalities is more effective, as compared to current usual primary care, in reducing both symptoms as related to the quality of voiding in elderly males.
详细描述
Guidelines fail to provide specific diagnostic criteria and clear indications for therapy in elderly male patients with lower urinary tract symptoms. Consequently, the group of patients diagnosed with LUTS in primary care is very heterogeneous, and daily care varies widely.
Consequently, efficacy trials of alpha-blockers, 5-alpha-reductase inhibitors and surgery performed in selected, well defined homogeneous populations cannot easily be generalised to the heterogeneous primary care situation.
A practical randomised trial enrolling patients on the basis of symptoms have the advantage of being of immediate practical value.
We compare a treatment protocol with clear indications for therapy with current usual care in a population selected on symptoms rather than well defined diseases or definite test results.
Two hundred eight subjects were randomised into intervention (N=104) and control (N=104) conditions.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •International Prostate Symptom Score > 7
- •Age > 55 years
排除标准
- •Heart failure
- •Diabetes type I
- •Psychiatric disorder/cognitive dysfunction
- •History of prostate surgery
- •Active treatment for lower urinary tract symptoms
结局指标
主要结局
Maximum urinary flow rate (Qmax)
Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])
次要结局
- incidence of acute urinary retention
- Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])
- incidence of urinary tract infections