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临床试验/NCT00780832
NCT00780832终止不适用

Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder

IWK Health Centre1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Change in Bladder Function Questionnaire score

研究概览

简要总结

The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications.

详细描述

Urinary symptoms such as frequency, urgency, nocturia, and incontinence occur in many women. Overactive bladder (OAB) accounts for forty to seventy percent of urinary incontinence. These symptoms can be mildly annoying to life altering. Many women wear pads or adult diapers daily and avoid social situations for fear of embarrassment. It is felt that up to sixteen percent of the adult population may suffer from these symptoms and many of these women seek medical help.

Currently, the standard of care for OAB includes some combination of lifestyle modification counseling, bladder retraining, or anticholinergic medications. It is anticipated that stimulants such as caffeine irritate the bladder and exacerbate OAB symptoms. There have been a few studies looking at the effect of caffeine but interventions have varied, and the results have been mixed.

Perhaps the most common treatment for significant OAB symptoms is the prescription of anticholinergic medications. We know that these are efficacious in many women but they can be expensive and have significant side effects4. In fact, many women discontinue their anticholinergics due to dry mouth, dry eyes, gastrointestinal, and genitourinary effects.

To date there have been no studies comparing caffeine reduction to anticholinergic medications.

Research Questions

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

性别
Female
接受健康志愿者

入选标准

  • Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
  • Women who consume > one cup (250ml) caffeinated beverage per day
  • Women who score $ 6 on the QUID Questionnaire for urgency symptoms

排除标准

  • Women currently receiving treatment for OAB symptoms
  • Women with narrow angle Glaucoma
  • Women taking anticholinergics or loop diuretics
  • Women with an untreated urinary tract infection. After resolution of the UTI, and if all other eligibility criteria are met, the woman can be a candidate for inclusion in the study.
  • Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
  • Women scoring >4 on the QUID Questionnaire for stress symptoms
  • Women with de novo symptoms following surgery
  • Women with major pelvic prolapse

研究组 & 干预措施

1

Active Comparator

Caffeine reduction through diet and beverage counselling

干预措施: Dietary Caffeine reduction (Behavioral)

2

Active Comparator

Anticholinergic medication

干预措施: Anticholinergic medication (Drug)

结局指标

主要结局

Change in Bladder Function Questionnaire score

时间窗: 30 days

次要结局

  • Does the amount of caffeine consumed relate to symptom severity?(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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