A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 5
- 主要终点
- urgencyepisodes
研究概览
简要总结
Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder.
The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).
详细描述
Program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women at the age of 18 and more
- •patients with overactive bladder
排除标准
- •dominance of stress incontinence
- •not able to attend sessions
- •do not to understand danish
- •do not want training in groups or individual
- •hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months)
- •no treatment for OAB up till 1 month before study and during study
- •no renal or neurological diseases, symptomatic cystitis or non regulated diabetes
- •no pregnancy during study
- •no normal gynecological examination
- •no operation in pelvis up till 3 month before studystart
- •no polyuria measured 2 times before studystart (> 40 ml/ kg/ day)
- •no upstart of treatment with medication during studystart which according to the investigator can create symptoms of OAB
- •no participation in other CT
研究组 & 干预措施
bladdertraining group
Cognitive training in groups at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
干预措施: bladdertraining in groups (Behavioral)
bladdertraining individually
Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
干预措施: bladdertraining individually (Behavioral)
结局指标
主要结局
urgencyepisodes
时间窗: after 2 month (end of study)
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
VAS score from ICI_OAB_Q
时间窗: after 2 month (studyend)
with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
urgeincontinence
时间窗: after 2 month (studyend)
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
次要结局
- Compliance in training(after 2 month (studyend))
- voiding frequency(after 2 month (studyend))
- Adverse events(after 2 month (studyend))