The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder.
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.
研究概览
简要总结
OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes.
The OAB Assessment Tool is a self-administered questionnaire (8-question self-filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.
详细描述
This study will be a non-randomised, non-placebo controlled prospective clinical trial.
We intend to recruit approximately 100 patients that will receive and fill out the questionnaire before and after medical treatment with detrusitol 4mg.
Study protocol will receive approval of the local ethical committee.
Method:
Twenty general practitioners (GP) will actively participate in the recruitment and treatment of these patients. After a brief inquiry, patients with urinary complaints will be offered the option of completing the OAB-V8 questionnaire and to participate in this trial if eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OAB score of ≥ 8
- •Age 20-80 years old
- •Patients must comply and agree to the requirement of taking only Detrusitol 4mg and no other new medication affecting the lower urinary tract system
- •Exclusion criteria:
- •Patients that are on any other treatment (whether medical or conservative) for OAB.
- •Patients with documented UTI.
- •Patients who have demonstrated hypersensitivity to the drug or its ingredients.
- •Where Detrusitol is contraindicated (i.e. patients with severe outlet obstruction, gastric retention, or uncontrolled narrow-angle glaucoma).
排除标准
- 未提供
结局指标
主要结局
A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.
次要结局
未报告次要终点