A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
研究概览
简要总结
This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine samples will also be assessed for underlying infected cause of OAB using urinalysis, microscopy and culture and cytokine assays (In collaboration with the University of Kent). We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB.
详细描述
We aim to measure outcomes initially, 6 weels and 6months follow-up.
- Resolution measured by Urgency Perception Scale (UPS). Resolution of urgency will be assessed with the UPS. The numbers of women with a Level 3 UPS score (hold and finish task) will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms.
- Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study.
- Change in urinary symptoms defined by Patient's Perception of Intensity Scale. Change in uregncy scores will be compared between the 2 arms of the study.
Secondary Outcome Measure:1. Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2. To identify whether urinary cytokines are present in a higher proportion of patients with OAB.
Inclusion Criteria
- Women with only OAB symptoms
- Women who have failed bladder drill and anticholinergic agents
- Women who stopped medication due to side-effects or lack of efficacy
- Currently receiving no treatment
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with only OAB symptoms
- •Women who have failed bladder drill and anticholinergic agents
- •Women who stopped medication due to side-effects or lack of efficacy
- •Currently receiving no treatment
排除标准
- •Patients with co-existing urodynamic stress incontinence
- •Patients with neurological diseases
- •Patients with pre-existing voiding dysfunction
- •Free flow rate <5th centile or equivalent reduced pressure flow rate OR
- •Post-void residual volume greater than 100ml
结局指标
主要结局
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
时间窗: 12-18months
1. Resolution measured by Urgency Perception Scale. 2. Change in quality of life status. 3. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale
次要结局
- Improved quality of life.(12-18 months)
研究者
Professor Jonathan Duckett
Consultant Gynaecologist
Medway NHS Foundation Trust